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Albashaireh 2017
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Drug coated balloon angioplasty for subclavian artery stenosis: A potential novel indication
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Subclavian artery stenosis is associated with increased cardiovascular disease mortality. It remains an important treatable cause of upper extremity, brain and cardiac ischemia. Endovascular treatment with angioplasty and stenting has become the preferred modality of treatment. Surgical revascularization is reserved for difficult cases with unfavorable anatomy to endovascular approach. Here we describe a case of subclavian artery stenosis causing subclavian steal syndrome with unfavorable anatomy to stenting treated successfully with drug coated balloon angioplasty with maintenance of patency at 6 months.
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Include
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DI2 - Off Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug coated balloon angioplasty for subclavian artery stenosis: A potential novel indication ###Abstract: Subclavian artery stenosis is associated with increased cardiovascular disease mortality. It remains an important treatable cause of upper extremity, brain and cardiac ischemia. Endovascular treatment with angioplasty and stenting has become the preferred modality of treatment. Surgical revascularization is reserved for difficult cases with unfavorable anatomy to endovascular approach. Here we describe a case of subclavian artery stenosis causing subclavian steal syndrome with unfavorable anatomy to stenting treated successfully with drug coated balloon angioplasty with maintenance of patency at 6 months. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug coated balloon angioplasty for subclavian artery stenosis: A potential novel indication ###Abstract: Subclavian artery stenosis is associated with increased cardiovascular disease mortality. It remains an important treatable cause of upper extremity, brain and cardiac ischemia. Endovascular treatment with angioplasty and stenting has become the preferred modality of treatment. Surgical revascularization is reserved for difficult cases with unfavorable anatomy to endovascular approach. Here we describe a case of subclavian artery stenosis causing subclavian steal syndrome with unfavorable anatomy to stenting treated successfully with drug coated balloon angioplasty with maintenance of patency at 6 months. [/INST] Include </s>
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Ansel 2018
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Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study
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Purpose: To report a post hoc analysis comparing outcomes between subjects who would have been included in the IN.PACT SFA randomized controlled trial vs those who would have been excluded. Methods: The 1406 subjects enrolled in the IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) were retrospectively assigned to a standard-use group (n=281) based on the inclusion and exclusion criteria from the randomized IN.PACT SFA trial; the remaining 1125 patients were assigned to the broader-use group. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated at 12 months. The composite primary safety endpoint was freedom from 30-day device- and procedure-related death plus freedom from 12-month target limb major amputation and clinically-driven target vessel revascularization (CD-TVR). Functional outcomes were evaluated with dedicated questionnaires. Results: Compared with the standard-use cohort, the broader-use lesions were longer, more calcified, and had more popliteal involvement, bilateral disease, and in-stent restenosis (p<0.001 for all). Freedom from 12-month CD-TLR by Kaplan-Meier analysis was 96.6% for the standard-use group and 91.6% for the broader-use group (p=0.005). The safety endpoint was 96.2% in the standard-use group and 91.0% in the broader-use group (p=0.003). The 12-month CD-TLR (3.4% standard-use vs 8.5% broader-use, p=0.004) and CD-TVR (4.2% standard-use vs 9.1% broader-use, p=0.008) were increased in the broader-use group. Twelve-month all-cause mortality was not increased (3.8% standard-use vs 3.4% broader-use, p=0.852). Conclusion: Post hoc analysis of the IN.PACT Global Study of real-world patients demonstrated consistent outcomes with significant clinical improvement to 12 months in subjects with complex lesions typically excluded from a randomized controlled trial.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study ###Abstract: Purpose: To report a post hoc analysis comparing outcomes between subjects who would have been included in the IN.PACT SFA randomized controlled trial vs those who would have been excluded. Methods: The 1406 subjects enrolled in the IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) were retrospectively assigned to a standard-use group (n=281) based on the inclusion and exclusion criteria from the randomized IN.PACT SFA trial; the remaining 1125 patients were assigned to the broader-use group. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated at 12 months. The composite primary safety endpoint was freedom from 30-day device- and procedure-related death plus freedom from 12-month target limb major amputation and clinically-driven target vessel revascularization (CD-TVR). Functional outcomes were evaluated with dedicated questionnaires. Results: Compared with the standard-use cohort, the broader-use lesions were longer, more calcified, and had more popliteal involvement, bilateral disease, and in-stent restenosis (p<0.001 for all). Freedom from 12-month CD-TLR by Kaplan-Meier analysis was 96.6% for the standard-use group and 91.6% for the broader-use group (p=0.005). The safety endpoint was 96.2% in the standard-use group and 91.0% in the broader-use group (p=0.003). The 12-month CD-TLR (3.4% standard-use vs 8.5% broader-use, p=0.004) and CD-TVR (4.2% standard-use vs 9.1% broader-use, p=0.008) were increased in the broader-use group. Twelve-month all-cause mortality was not increased (3.8% standard-use vs 3.4% broader-use, p=0.852). Conclusion: Post hoc analysis of the IN.PACT Global Study of real-world patients demonstrated consistent outcomes with significant clinical improvement to 12 months in subjects with complex lesions typically excluded from a randomized controlled trial. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study ###Abstract: Purpose: To report a post hoc analysis comparing outcomes between subjects who would have been included in the IN.PACT SFA randomized controlled trial vs those who would have been excluded. Methods: The 1406 subjects enrolled in the IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) were retrospectively assigned to a standard-use group (n=281) based on the inclusion and exclusion criteria from the randomized IN.PACT SFA trial; the remaining 1125 patients were assigned to the broader-use group. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated at 12 months. The composite primary safety endpoint was freedom from 30-day device- and procedure-related death plus freedom from 12-month target limb major amputation and clinically-driven target vessel revascularization (CD-TVR). Functional outcomes were evaluated with dedicated questionnaires. Results: Compared with the standard-use cohort, the broader-use lesions were longer, more calcified, and had more popliteal involvement, bilateral disease, and in-stent restenosis (p<0.001 for all). Freedom from 12-month CD-TLR by Kaplan-Meier analysis was 96.6% for the standard-use group and 91.6% for the broader-use group (p=0.005). The safety endpoint was 96.2% in the standard-use group and 91.0% in the broader-use group (p=0.003). The 12-month CD-TLR (3.4% standard-use vs 8.5% broader-use, p=0.004) and CD-TVR (4.2% standard-use vs 9.1% broader-use, p=0.008) were increased in the broader-use group. Twelve-month all-cause mortality was not increased (3.8% standard-use vs 3.4% broader-use, p=0.852). Conclusion: Post hoc analysis of the IN.PACT Global Study of real-world patients demonstrated consistent outcomes with significant clinical improvement to 12 months in subjects with complex lesions typically excluded from a randomized controlled trial. [/INST] Include </s>
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Bague 2017
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Femoropopliteal In-stent Restenosis Repair: Midterm Outcomes After Paclitaxel Eluting Balloon Use (PLAISIR Trial)
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Objective The aim was to assess 18 month outcomes of the paclitaxel eluting balloon (PEB) in patients with femoropopliteal (FP) in-stent restenosis (ISR). Methods In a national prospective and multicentre cohort study, symptomatic patients with femoropopliteal in-stent restenosis were included from January 2012 to June 2013. Patients were treated by paclitaxel eluting balloon angioplasty (In Pact Admiral, Medtronic, Santa Rosa, CA, USA). Clinical and duplex scan follow-up evaluations were performed at 1, 3, 6, 9, 12, and 18 months. The primary endpoint was freedom from target lesion revascularisation (TLR) at 12 months. Secondary endpoints were major adverse cardiovascular events (MACE), Target extremity revascularisation (TER), primary and secondary sustained clinical improvement, recurrent restenosis rate, primary and secondary patency, quality of life assessed by EQ-5D questionnaire, technical success, clinical success, and length of stay Results A total of 53 patients were enrolled. After a blinded review, 10 patients were defined as protocol violation because restenosis occurred more than 2 years after stent implantation. Procedures were performed in 55 limbs, 48 (87%) for claudication and 7 (13%) for critical limb ischaemia. The mean diameter and length of PEB were 6 ± 0.57 mm and 86 mm ± 32 mm, follow-up was 17 months (range 1–19). At 1 year, the survival rate was 96 ± 2.7% and freedom from TLR and TER were 90.2 ± 4.2% and 85 ± 5%, respectively. Sustained primary and secondary clinical improvements were 78.6 ± 5.7% and 92.0 ± 3.8%, respectively. At 1 year, the primary patency rate was 83.7 ± 5.0%. Prior to the procedure, the mean EQ-5D score was 66 ± 14 and 74 ± 16 at 1 year (p = .10). Two patients died during follow-up; one patient died 33 days after the procedure because of limb ischaemia. Conclusion PEB for the treatment of FP ISR is associated with a low rate of re-interventions and restenosis. Clinical improvement is maintained at 18 months.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Femoropopliteal In-stent Restenosis Repair: Midterm Outcomes After Paclitaxel Eluting Balloon Use (PLAISIR Trial) ###Abstract: Objective The aim was to assess 18 month outcomes of the paclitaxel eluting balloon (PEB) in patients with femoropopliteal (FP) in-stent restenosis (ISR). Methods In a national prospective and multicentre cohort study, symptomatic patients with femoropopliteal in-stent restenosis were included from January 2012 to June 2013. Patients were treated by paclitaxel eluting balloon angioplasty (In Pact Admiral, Medtronic, Santa Rosa, CA, USA). Clinical and duplex scan follow-up evaluations were performed at 1, 3, 6, 9, 12, and 18 months. The primary endpoint was freedom from target lesion revascularisation (TLR) at 12 months. Secondary endpoints were major adverse cardiovascular events (MACE), Target extremity revascularisation (TER), primary and secondary sustained clinical improvement, recurrent restenosis rate, primary and secondary patency, quality of life assessed by EQ-5D questionnaire, technical success, clinical success, and length of stay Results A total of 53 patients were enrolled. After a blinded review, 10 patients were defined as protocol violation because restenosis occurred more than 2 years after stent implantation. Procedures were performed in 55 limbs, 48 (87%) for claudication and 7 (13%) for critical limb ischaemia. The mean diameter and length of PEB were 6 ± 0.57 mm and 86 mm ± 32 mm, follow-up was 17 months (range 1–19). At 1 year, the survival rate was 96 ± 2.7% and freedom from TLR and TER were 90.2 ± 4.2% and 85 ± 5%, respectively. Sustained primary and secondary clinical improvements were 78.6 ± 5.7% and 92.0 ± 3.8%, respectively. At 1 year, the primary patency rate was 83.7 ± 5.0%. Prior to the procedure, the mean EQ-5D score was 66 ± 14 and 74 ± 16 at 1 year (p = .10). Two patients died during follow-up; one patient died 33 days after the procedure because of limb ischaemia. Conclusion PEB for the treatment of FP ISR is associated with a low rate of re-interventions and restenosis. Clinical improvement is maintained at 18 months. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Femoropopliteal In-stent Restenosis Repair: Midterm Outcomes After Paclitaxel Eluting Balloon Use (PLAISIR Trial) ###Abstract: Objective The aim was to assess 18 month outcomes of the paclitaxel eluting balloon (PEB) in patients with femoropopliteal (FP) in-stent restenosis (ISR). Methods In a national prospective and multicentre cohort study, symptomatic patients with femoropopliteal in-stent restenosis were included from January 2012 to June 2013. Patients were treated by paclitaxel eluting balloon angioplasty (In Pact Admiral, Medtronic, Santa Rosa, CA, USA). Clinical and duplex scan follow-up evaluations were performed at 1, 3, 6, 9, 12, and 18 months. The primary endpoint was freedom from target lesion revascularisation (TLR) at 12 months. Secondary endpoints were major adverse cardiovascular events (MACE), Target extremity revascularisation (TER), primary and secondary sustained clinical improvement, recurrent restenosis rate, primary and secondary patency, quality of life assessed by EQ-5D questionnaire, technical success, clinical success, and length of stay Results A total of 53 patients were enrolled. After a blinded review, 10 patients were defined as protocol violation because restenosis occurred more than 2 years after stent implantation. Procedures were performed in 55 limbs, 48 (87%) for claudication and 7 (13%) for critical limb ischaemia. The mean diameter and length of PEB were 6 ± 0.57 mm and 86 mm ± 32 mm, follow-up was 17 months (range 1–19). At 1 year, the survival rate was 96 ± 2.7% and freedom from TLR and TER were 90.2 ± 4.2% and 85 ± 5%, respectively. Sustained primary and secondary clinical improvements were 78.6 ± 5.7% and 92.0 ± 3.8%, respectively. At 1 year, the primary patency rate was 83.7 ± 5.0%. Prior to the procedure, the mean EQ-5D score was 66 ± 14 and 74 ± 16 at 1 year (p = .10). Two patients died during follow-up; one patient died 33 days after the procedure because of limb ischaemia. Conclusion PEB for the treatment of FP ISR is associated with a low rate of re-interventions and restenosis. Clinical improvement is maintained at 18 months. [/INST] Include </s>
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Björkman 2018
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Drug-Coated Versus Plain Balloon Angioplasty In Arteriovenous Fistulas: A Randomized, Controlled Study With 1-Year Follow-Up (The Drecorest Ii-Study)
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Background and Aims: Stenosis due to intimal hyperplasia and restenosis after initially successful percutaneous angioplasty are common reasons for failing arteriovenous fistulas. The aim of this study was to evaluate the effect of drug-coated balloons in the treatment of arteriovenous fistula stenosis. Design: Single-center, parallel group, randomized controlled trial. Block randomized by sealed envelope 1:1. Materials and Methods: A total of 39 patients with primary or recurrent stenosis in a failing native arteriovenous fistulas were randomized to drug-coated balloon (n = 19) or standard balloon angioplasty (n = 20). Follow-up was 1 year. Primary outcome measure was target lesion revascularization. Results: In all, 36 stenoses were analyzed; three patients were excluded due to technical failure after randomization. A total of 88.9% (16/18) in the drug-coated balloon group was revascularized or occluded within 1 year, compared to 22.2% (4/18) of the stenoses in the balloon angioplasty group (relative risk for drug-coated balloon 7.09). Mean time-to- target lesion revascularization was 110 and 193 days after the drug-coated balloon and balloon angioplasty, respectively (p = 0.06). Conclusions: With 1-year follow-up, the target lesion revascularization-free survival after drug-coated balloon-treatment was clearly worse. The reason for this remains unknown, but it may be due to differences in the biological response to paclitaxel in the venous arteriovenous fistula-wall compared to its antiproliferative effect in the arterial wall after drug-coated balloon treatment of atherosclerotic occlusive lesions. Trial registration: ClinicalTrials.gov NCT03036241
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Versus Plain Balloon Angioplasty In Arteriovenous Fistulas: A Randomized, Controlled Study With 1-Year Follow-Up (The Drecorest Ii-Study) ###Abstract: Background and Aims: Stenosis due to intimal hyperplasia and restenosis after initially successful percutaneous angioplasty are common reasons for failing arteriovenous fistulas. The aim of this study was to evaluate the effect of drug-coated balloons in the treatment of arteriovenous fistula stenosis. Design: Single-center, parallel group, randomized controlled trial. Block randomized by sealed envelope 1:1. Materials and Methods: A total of 39 patients with primary or recurrent stenosis in a failing native arteriovenous fistulas were randomized to drug-coated balloon (n = 19) or standard balloon angioplasty (n = 20). Follow-up was 1 year. Primary outcome measure was target lesion revascularization. Results: In all, 36 stenoses were analyzed; three patients were excluded due to technical failure after randomization. A total of 88.9% (16/18) in the drug-coated balloon group was revascularized or occluded within 1 year, compared to 22.2% (4/18) of the stenoses in the balloon angioplasty group (relative risk for drug-coated balloon 7.09). Mean time-to- target lesion revascularization was 110 and 193 days after the drug-coated balloon and balloon angioplasty, respectively (p = 0.06). Conclusions: With 1-year follow-up, the target lesion revascularization-free survival after drug-coated balloon-treatment was clearly worse. The reason for this remains unknown, but it may be due to differences in the biological response to paclitaxel in the venous arteriovenous fistula-wall compared to its antiproliferative effect in the arterial wall after drug-coated balloon treatment of atherosclerotic occlusive lesions. Trial registration: ClinicalTrials.gov NCT03036241 [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Versus Plain Balloon Angioplasty In Arteriovenous Fistulas: A Randomized, Controlled Study With 1-Year Follow-Up (The Drecorest Ii-Study) ###Abstract: Background and Aims: Stenosis due to intimal hyperplasia and restenosis after initially successful percutaneous angioplasty are common reasons for failing arteriovenous fistulas. The aim of this study was to evaluate the effect of drug-coated balloons in the treatment of arteriovenous fistula stenosis. Design: Single-center, parallel group, randomized controlled trial. Block randomized by sealed envelope 1:1. Materials and Methods: A total of 39 patients with primary or recurrent stenosis in a failing native arteriovenous fistulas were randomized to drug-coated balloon (n = 19) or standard balloon angioplasty (n = 20). Follow-up was 1 year. Primary outcome measure was target lesion revascularization. Results: In all, 36 stenoses were analyzed; three patients were excluded due to technical failure after randomization. A total of 88.9% (16/18) in the drug-coated balloon group was revascularized or occluded within 1 year, compared to 22.2% (4/18) of the stenoses in the balloon angioplasty group (relative risk for drug-coated balloon 7.09). Mean time-to- target lesion revascularization was 110 and 193 days after the drug-coated balloon and balloon angioplasty, respectively (p = 0.06). Conclusions: With 1-year follow-up, the target lesion revascularization-free survival after drug-coated balloon-treatment was clearly worse. The reason for this remains unknown, but it may be due to differences in the biological response to paclitaxel in the venous arteriovenous fistula-wall compared to its antiproliferative effect in the arterial wall after drug-coated balloon treatment of atherosclerotic occlusive lesions. Trial registration: ClinicalTrials.gov NCT03036241 [/INST] Include </s>
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Brodmann 2017
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Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The IN.PACT Global Study De Novo In-Stent Restenosis Imaging Cohort
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Objectives This study sought to evaluate the safety and effectiveness of a paclitaxel-coated drug-coated balloon (DCB) for the treatment of patients with de novo in-stent restenosis (ISR). Background Treatment of patients with ISR remains a challenge. Current strategies are plagued by high rates of recurrent restenosis and need for reintervention. The best intervention for ISR remains to be elucidated. Methods The IN.PACT Global study is an independently adjudicated multicenter, prospective, single-arm study that enrolled 1,535 subjects with symptomatic atherosclerotic disease of the superficial femoral and/or popliteal arteries, including de novo ISR lesions. Patients enrolled in the pre-specified ISR imaging cohort were evaluated for vessel patency and reintervention within the 12-month follow-up period. Results A total of 131 subjects with 149 ISR lesions were included for analysis. The mean age of the cohort was 67.8 years. Mean lesion length was 17.17 ± 10.47 cm, including 34.0% total occlusions and 59.1% calcified lesions. The 12-month Kaplan-Meier estimate of primary patency was 88.7%. The rate of clinically driven target lesion revascularization (CD TLR) at 12 months was 7.3%. The primary safety outcome, a composite of freedom from device- and procedure-related mortality through 30 days and freedom from major target limb amputation and CD TLR within 12 months, was 92.7%. There were no major target limb amputations, no deaths, and a low (0.8%) thrombosis rate. Conclusions Results from the ISR imaging cohort demonstrate high patency and a low rate of CD TLR at 12 months. These data confirm the safety and effectiveness of the IN.PACT Admiral DCB (Medtronic, Dublin, Ireland) in complex femoropopliteal lesions, including this challenging subset.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The IN.PACT Global Study De Novo In-Stent Restenosis Imaging Cohort ###Abstract: Objectives This study sought to evaluate the safety and effectiveness of a paclitaxel-coated drug-coated balloon (DCB) for the treatment of patients with de novo in-stent restenosis (ISR). Background Treatment of patients with ISR remains a challenge. Current strategies are plagued by high rates of recurrent restenosis and need for reintervention. The best intervention for ISR remains to be elucidated. Methods The IN.PACT Global study is an independently adjudicated multicenter, prospective, single-arm study that enrolled 1,535 subjects with symptomatic atherosclerotic disease of the superficial femoral and/or popliteal arteries, including de novo ISR lesions. Patients enrolled in the pre-specified ISR imaging cohort were evaluated for vessel patency and reintervention within the 12-month follow-up period. Results A total of 131 subjects with 149 ISR lesions were included for analysis. The mean age of the cohort was 67.8 years. Mean lesion length was 17.17 ± 10.47 cm, including 34.0% total occlusions and 59.1% calcified lesions. The 12-month Kaplan-Meier estimate of primary patency was 88.7%. The rate of clinically driven target lesion revascularization (CD TLR) at 12 months was 7.3%. The primary safety outcome, a composite of freedom from device- and procedure-related mortality through 30 days and freedom from major target limb amputation and CD TLR within 12 months, was 92.7%. There were no major target limb amputations, no deaths, and a low (0.8%) thrombosis rate. Conclusions Results from the ISR imaging cohort demonstrate high patency and a low rate of CD TLR at 12 months. These data confirm the safety and effectiveness of the IN.PACT Admiral DCB (Medtronic, Dublin, Ireland) in complex femoropopliteal lesions, including this challenging subset. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The IN.PACT Global Study De Novo In-Stent Restenosis Imaging Cohort ###Abstract: Objectives This study sought to evaluate the safety and effectiveness of a paclitaxel-coated drug-coated balloon (DCB) for the treatment of patients with de novo in-stent restenosis (ISR). Background Treatment of patients with ISR remains a challenge. Current strategies are plagued by high rates of recurrent restenosis and need for reintervention. The best intervention for ISR remains to be elucidated. Methods The IN.PACT Global study is an independently adjudicated multicenter, prospective, single-arm study that enrolled 1,535 subjects with symptomatic atherosclerotic disease of the superficial femoral and/or popliteal arteries, including de novo ISR lesions. Patients enrolled in the pre-specified ISR imaging cohort were evaluated for vessel patency and reintervention within the 12-month follow-up period. Results A total of 131 subjects with 149 ISR lesions were included for analysis. The mean age of the cohort was 67.8 years. Mean lesion length was 17.17 ± 10.47 cm, including 34.0% total occlusions and 59.1% calcified lesions. The 12-month Kaplan-Meier estimate of primary patency was 88.7%. The rate of clinically driven target lesion revascularization (CD TLR) at 12 months was 7.3%. The primary safety outcome, a composite of freedom from device- and procedure-related mortality through 30 days and freedom from major target limb amputation and CD TLR within 12 months, was 92.7%. There were no major target limb amputations, no deaths, and a low (0.8%) thrombosis rate. Conclusions Results from the ISR imaging cohort demonstrate high patency and a low rate of CD TLR at 12 months. These data confirm the safety and effectiveness of the IN.PACT Admiral DCB (Medtronic, Dublin, Ireland) in complex femoropopliteal lesions, including this challenging subset. [/INST] Include </s>
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Brodmann 2020
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Optimized drug-coated balloon angioplasty of the superficial femoral and proximal popliteal arteries using the Tack Endovascular System: TOBA III 12-month results
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Objective: The Tack Endovascular System (Intact Vascular, Wayne, Pa) combines low-metallic content with focal delivery to seal areas of dissection associated with balloon angioplasty. The device system is designed to treat vascular dissections in the superficial femoral and proximal popliteal arteries. Tack implants exert low radial force and are associated with minimal metal burden, which reduces the mechanical stress on the arterial wall in treating dissections after balloon angioplasty. This study investigated the safety and effectiveness of the Tack Endovascular System in patients with dissections after drug-coated balloon (DCB) angioplasty. Methods: The Tack Optimized Balloon Angioplasty III (TOBA III) study is a prospective, multicenter, single-arm study in which patients who underwent percutaneous transluminal angioplasty with the Medtronic IN.PACT Admiral DCB (Medtronic, Dublin, Ireland) and experienced dissection after angioplasty were treated with Tack implants. The primary end points were freedom from major adverse events at 30 days and primary patency at 12 months. Results: A total of 201 patients were enrolled in the trial, 169 with standard-length lesions (≥20 mm and ≤150 mm) and 32 with long-length lesions (>150 mm and ≤250 mm). Safety and effectiveness results were favorable compared with historical benchmarks at 12 months in the standard-lesion cohort. Notably, patients in the standard-lesion cohort experienced 95.0% primary patency, 97.5% freedom from clinically driven target lesion revascularization, 100% freedom from amputation, and 100% survival at 12 months (P <.0001). Primary patency in long-lesion patients was 89.3%, freedom from clinically driven target lesion revascularization was 96.8%, and freedom from amputation was 100% at 12 months. Device success was achieved in 95.8% (182/190) and 97.7% (43/44) of devices deployed into standard-lesion and long-lesion patients, respectively. Procedural success was 99.4% (168/169) and 100% (44/44) in the standard-lesion and long-lesion cohorts, respectively, with only one bailout stent placed in the entire population. Conclusions: The Tack Endovascular System is a safe and effective treatment option for patients with dissections after angioplasty in the superficial femoral and proximal popliteal arteries, with high patency, low rates of secondary intervention, and low incidence of bailout stenting when it is used in combination with DCB.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Optimized drug-coated balloon angioplasty of the superficial femoral and proximal popliteal arteries using the Tack Endovascular System: TOBA III 12-month results ###Abstract: Objective: The Tack Endovascular System (Intact Vascular, Wayne, Pa) combines low-metallic content with focal delivery to seal areas of dissection associated with balloon angioplasty. The device system is designed to treat vascular dissections in the superficial femoral and proximal popliteal arteries. Tack implants exert low radial force and are associated with minimal metal burden, which reduces the mechanical stress on the arterial wall in treating dissections after balloon angioplasty. This study investigated the safety and effectiveness of the Tack Endovascular System in patients with dissections after drug-coated balloon (DCB) angioplasty. Methods: The Tack Optimized Balloon Angioplasty III (TOBA III) study is a prospective, multicenter, single-arm study in which patients who underwent percutaneous transluminal angioplasty with the Medtronic IN.PACT Admiral DCB (Medtronic, Dublin, Ireland) and experienced dissection after angioplasty were treated with Tack implants. The primary end points were freedom from major adverse events at 30 days and primary patency at 12 months. Results: A total of 201 patients were enrolled in the trial, 169 with standard-length lesions (≥20 mm and ≤150 mm) and 32 with long-length lesions (>150 mm and ≤250 mm). Safety and effectiveness results were favorable compared with historical benchmarks at 12 months in the standard-lesion cohort. Notably, patients in the standard-lesion cohort experienced 95.0% primary patency, 97.5% freedom from clinically driven target lesion revascularization, 100% freedom from amputation, and 100% survival at 12 months (P <.0001). Primary patency in long-lesion patients was 89.3%, freedom from clinically driven target lesion revascularization was 96.8%, and freedom from amputation was 100% at 12 months. Device success was achieved in 95.8% (182/190) and 97.7% (43/44) of devices deployed into standard-lesion and long-lesion patients, respectively. Procedural success was 99.4% (168/169) and 100% (44/44) in the standard-lesion and long-lesion cohorts, respectively, with only one bailout stent placed in the entire population. Conclusions: The Tack Endovascular System is a safe and effective treatment option for patients with dissections after angioplasty in the superficial femoral and proximal popliteal arteries, with high patency, low rates of secondary intervention, and low incidence of bailout stenting when it is used in combination with DCB. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Optimized drug-coated balloon angioplasty of the superficial femoral and proximal popliteal arteries using the Tack Endovascular System: TOBA III 12-month results ###Abstract: Objective: The Tack Endovascular System (Intact Vascular, Wayne, Pa) combines low-metallic content with focal delivery to seal areas of dissection associated with balloon angioplasty. The device system is designed to treat vascular dissections in the superficial femoral and proximal popliteal arteries. Tack implants exert low radial force and are associated with minimal metal burden, which reduces the mechanical stress on the arterial wall in treating dissections after balloon angioplasty. This study investigated the safety and effectiveness of the Tack Endovascular System in patients with dissections after drug-coated balloon (DCB) angioplasty. Methods: The Tack Optimized Balloon Angioplasty III (TOBA III) study is a prospective, multicenter, single-arm study in which patients who underwent percutaneous transluminal angioplasty with the Medtronic IN.PACT Admiral DCB (Medtronic, Dublin, Ireland) and experienced dissection after angioplasty were treated with Tack implants. The primary end points were freedom from major adverse events at 30 days and primary patency at 12 months. Results: A total of 201 patients were enrolled in the trial, 169 with standard-length lesions (≥20 mm and ≤150 mm) and 32 with long-length lesions (>150 mm and ≤250 mm). Safety and effectiveness results were favorable compared with historical benchmarks at 12 months in the standard-lesion cohort. Notably, patients in the standard-lesion cohort experienced 95.0% primary patency, 97.5% freedom from clinically driven target lesion revascularization, 100% freedom from amputation, and 100% survival at 12 months (P <.0001). Primary patency in long-lesion patients was 89.3%, freedom from clinically driven target lesion revascularization was 96.8%, and freedom from amputation was 100% at 12 months. Device success was achieved in 95.8% (182/190) and 97.7% (43/44) of devices deployed into standard-lesion and long-lesion patients, respectively. Procedural success was 99.4% (168/169) and 100% (44/44) in the standard-lesion and long-lesion cohorts, respectively, with only one bailout stent placed in the entire population. Conclusions: The Tack Endovascular System is a safe and effective treatment option for patients with dissections after angioplasty in the superficial femoral and proximal popliteal arteries, with high patency, low rates of secondary intervention, and low incidence of bailout stenting when it is used in combination with DCB. [/INST] Include </s>
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Cantu 2020
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Outcomes of Drug-Coated Balloon Angioplasty vs. Conventional Balloon Angioplasty for Endovascular Treatment of Common Femoral Artery Atherosclerotic Disease
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Background: Atherosclerotic disease of the common femoral artery (CFA), commonly associated with multilevel disease affecting the femoropopliteal segment, can cause claudication or contribute to critical limb ischemia. Although endovascular therapy for the management of peripheral arterial disease (PAD) has been increasingly utilized, its role in CFA lesions remains controversial. The aim of this study was to investigate the safety and efficacy of drug (DCB) vs non drug coated balloon angioplasty (BA) at the CFA segment. Methods: In this two-center study, we identified 154 patients treated either with DCB (n = 47) or BA (n = 107) for CFA lesions. Hazard ratios (HR) and the respective 95% confidence interval (CI) were synthesized to examine the association between the two groups in terms of target lesion revascularization (TLR), limb loss, and major adverse limb event (MALE) at 12 and 24 months of follow up. Results: This real-world population included a high percentage of patients with critical limb ischemia (43%) and moderate to severe lesion calcification (75%). Adjunctive atherectomy was performed in 97.9% of DCB cases (N = 46/47) and 44.7% of BA cases (N = 51/114). The overall procedural success rate was 95% without any differences between the two groups. Post-angioplasty dissections were observed in 15 cases [DCB: 8.5% (N = 4/47) vs BA: 9.7% (N = 11/113); p = .81], while distal embolization occurred in one patient in the DCB group and one in the BA group (p = .52). Provisional stenting was more commonly necessary in BA vs. DCB cases (12.3% vs 2.13%, p = .044). Physiologic assessment during follow up demonstrated a better mean 2-year ABI for the DCB group (mean: 0.9; SD: 0.2) vs BA group (mean: 0.6; SD: 0.4), although statistical significance was not reached (p = .06). No difference between the two groups was detected in terms of freedom from TLR (DCB: 75.5% vs BA: 86.8%; HR: 1.31; 95% CI: 0.46–3.67; p = .61), freedom from limb loss (DCB: 83.8% vs BA: 83.6%; HR: 1.04; 95% CI: 0.36–2.99; p = .94) or freedom from MALE (DCB: 83.5% vs BA: 78%; HR: 0.73; 95% CI: 0.26–1.99; p = .53) at 24 m of follow up. However, at the end of follow up more deaths were observed in patients treated with BA than DCB (DCB: 14.9% vs BA: 31.7%; p = .03). Patients who required provisional stenting were at higher risk for limb loss 2 years after the initial procedure (multivariate: HR: 4.54; 95% CI: 1.09–18.85; p = .04). Conclusions: Both DCB and non-DCB strategies are effective modalities for revascularization of patients with CFA lesions. Larger prospective studies are necessary to determine the relative benefit, if any, of drug-eluting technologies for the treatment of common femoral artery disease.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Outcomes of Drug-Coated Balloon Angioplasty vs. Conventional Balloon Angioplasty for Endovascular Treatment of Common Femoral Artery Atherosclerotic Disease ###Abstract: Background: Atherosclerotic disease of the common femoral artery (CFA), commonly associated with multilevel disease affecting the femoropopliteal segment, can cause claudication or contribute to critical limb ischemia. Although endovascular therapy for the management of peripheral arterial disease (PAD) has been increasingly utilized, its role in CFA lesions remains controversial. The aim of this study was to investigate the safety and efficacy of drug (DCB) vs non drug coated balloon angioplasty (BA) at the CFA segment. Methods: In this two-center study, we identified 154 patients treated either with DCB (n = 47) or BA (n = 107) for CFA lesions. Hazard ratios (HR) and the respective 95% confidence interval (CI) were synthesized to examine the association between the two groups in terms of target lesion revascularization (TLR), limb loss, and major adverse limb event (MALE) at 12 and 24 months of follow up. Results: This real-world population included a high percentage of patients with critical limb ischemia (43%) and moderate to severe lesion calcification (75%). Adjunctive atherectomy was performed in 97.9% of DCB cases (N = 46/47) and 44.7% of BA cases (N = 51/114). The overall procedural success rate was 95% without any differences between the two groups. Post-angioplasty dissections were observed in 15 cases [DCB: 8.5% (N = 4/47) vs BA: 9.7% (N = 11/113); p = .81], while distal embolization occurred in one patient in the DCB group and one in the BA group (p = .52). Provisional stenting was more commonly necessary in BA vs. DCB cases (12.3% vs 2.13%, p = .044). Physiologic assessment during follow up demonstrated a better mean 2-year ABI for the DCB group (mean: 0.9; SD: 0.2) vs BA group (mean: 0.6; SD: 0.4), although statistical significance was not reached (p = .06). No difference between the two groups was detected in terms of freedom from TLR (DCB: 75.5% vs BA: 86.8%; HR: 1.31; 95% CI: 0.46–3.67; p = .61), freedom from limb loss (DCB: 83.8% vs BA: 83.6%; HR: 1.04; 95% CI: 0.36–2.99; p = .94) or freedom from MALE (DCB: 83.5% vs BA: 78%; HR: 0.73; 95% CI: 0.26–1.99; p = .53) at 24 m of follow up. However, at the end of follow up more deaths were observed in patients treated with BA than DCB (DCB: 14.9% vs BA: 31.7%; p = .03). Patients who required provisional stenting were at higher risk for limb loss 2 years after the initial procedure (multivariate: HR: 4.54; 95% CI: 1.09–18.85; p = .04). Conclusions: Both DCB and non-DCB strategies are effective modalities for revascularization of patients with CFA lesions. Larger prospective studies are necessary to determine the relative benefit, if any, of drug-eluting technologies for the treatment of common femoral artery disease. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Outcomes of Drug-Coated Balloon Angioplasty vs. Conventional Balloon Angioplasty for Endovascular Treatment of Common Femoral Artery Atherosclerotic Disease ###Abstract: Background: Atherosclerotic disease of the common femoral artery (CFA), commonly associated with multilevel disease affecting the femoropopliteal segment, can cause claudication or contribute to critical limb ischemia. Although endovascular therapy for the management of peripheral arterial disease (PAD) has been increasingly utilized, its role in CFA lesions remains controversial. The aim of this study was to investigate the safety and efficacy of drug (DCB) vs non drug coated balloon angioplasty (BA) at the CFA segment. Methods: In this two-center study, we identified 154 patients treated either with DCB (n = 47) or BA (n = 107) for CFA lesions. Hazard ratios (HR) and the respective 95% confidence interval (CI) were synthesized to examine the association between the two groups in terms of target lesion revascularization (TLR), limb loss, and major adverse limb event (MALE) at 12 and 24 months of follow up. Results: This real-world population included a high percentage of patients with critical limb ischemia (43%) and moderate to severe lesion calcification (75%). Adjunctive atherectomy was performed in 97.9% of DCB cases (N = 46/47) and 44.7% of BA cases (N = 51/114). The overall procedural success rate was 95% without any differences between the two groups. Post-angioplasty dissections were observed in 15 cases [DCB: 8.5% (N = 4/47) vs BA: 9.7% (N = 11/113); p = .81], while distal embolization occurred in one patient in the DCB group and one in the BA group (p = .52). Provisional stenting was more commonly necessary in BA vs. DCB cases (12.3% vs 2.13%, p = .044). Physiologic assessment during follow up demonstrated a better mean 2-year ABI for the DCB group (mean: 0.9; SD: 0.2) vs BA group (mean: 0.6; SD: 0.4), although statistical significance was not reached (p = .06). No difference between the two groups was detected in terms of freedom from TLR (DCB: 75.5% vs BA: 86.8%; HR: 1.31; 95% CI: 0.46–3.67; p = .61), freedom from limb loss (DCB: 83.8% vs BA: 83.6%; HR: 1.04; 95% CI: 0.36–2.99; p = .94) or freedom from MALE (DCB: 83.5% vs BA: 78%; HR: 0.73; 95% CI: 0.26–1.99; p = .53) at 24 m of follow up. However, at the end of follow up more deaths were observed in patients treated with BA than DCB (DCB: 14.9% vs BA: 31.7%; p = .03). Patients who required provisional stenting were at higher risk for limb loss 2 years after the initial procedure (multivariate: HR: 4.54; 95% CI: 1.09–18.85; p = .04). Conclusions: Both DCB and non-DCB strategies are effective modalities for revascularization of patients with CFA lesions. Larger prospective studies are necessary to determine the relative benefit, if any, of drug-eluting technologies for the treatment of common femoral artery disease. [/INST] Include </s>
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Chan 2020
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Lumivascular optical coherence tomography– guided atherectomy in recurrent femoropopliteal occlusive diseases associated with in-stent restenosis: Case-series report
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Lumivascular optical coherence tomography (OCT) is a novel adjunct in the field of medicine. It offers clear real-time imaging of artery walls before and during endovascular intervention. This study reports our initial experience on the use of lumivascular OCT-guided atherectomy in the management of two patients with recurrent restenosis in their femoropo-pliteal arteries associated with in-stent restenosis. Endovascular procedures were successful with a Pantheris atherectomy device (Avinger, Redwood City, CA, USA) and drug-eluting balloons. The OCT images clearly distinguished normal anatomy from plaque pathology, were of great advantage in both the accurate diagnosis and treatment of target lesions, and may reduce radiation during the endovascular procedure. However, the price of the device and its need for contrast infusion limit its routine clinical use.
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Include
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DI3 - Case Report
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Lumivascular optical coherence tomography– guided atherectomy in recurrent femoropopliteal occlusive diseases associated with in-stent restenosis: Case-series report ###Abstract: Lumivascular optical coherence tomography (OCT) is a novel adjunct in the field of medicine. It offers clear real-time imaging of artery walls before and during endovascular intervention. This study reports our initial experience on the use of lumivascular OCT-guided atherectomy in the management of two patients with recurrent restenosis in their femoropo-pliteal arteries associated with in-stent restenosis. Endovascular procedures were successful with a Pantheris atherectomy device (Avinger, Redwood City, CA, USA) and drug-eluting balloons. The OCT images clearly distinguished normal anatomy from plaque pathology, were of great advantage in both the accurate diagnosis and treatment of target lesions, and may reduce radiation during the endovascular procedure. However, the price of the device and its need for contrast infusion limit its routine clinical use. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Lumivascular optical coherence tomography– guided atherectomy in recurrent femoropopliteal occlusive diseases associated with in-stent restenosis: Case-series report ###Abstract: Lumivascular optical coherence tomography (OCT) is a novel adjunct in the field of medicine. It offers clear real-time imaging of artery walls before and during endovascular intervention. This study reports our initial experience on the use of lumivascular OCT-guided atherectomy in the management of two patients with recurrent restenosis in their femoropo-pliteal arteries associated with in-stent restenosis. Endovascular procedures were successful with a Pantheris atherectomy device (Avinger, Redwood City, CA, USA) and drug-eluting balloons. The OCT images clearly distinguished normal anatomy from plaque pathology, were of great advantage in both the accurate diagnosis and treatment of target lesions, and may reduce radiation during the endovascular procedure. However, the price of the device and its need for contrast infusion limit its routine clinical use. [/INST] Include </s>
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Chen 2019
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IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population
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Purpose: To confirm the safety and effectiveness of the IN.PACT Admiral drug-coated balloon (DCB) as a treatment for de novo and native artery restenotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery in Chinese subjects. Materials and Methods: IN.PACT SFA China (ClinicalTrials.gov identifier NCT02118532) was a single-arm, independently adjudicated, prospective, premarket study that enrolled 143 subjects (mean age 66.8±7.7 years; 107 men) at 15 centers. The predominant risk factors were hypertension (104, 72.7%) and diabetes mellitus (66, 46.2%). The majority of subjects were classified as Rutherford category 2 or 3 [69 (48.3%) and 55 (38.5%), respectively]; 19 (13.3%) subjects had critical limb ischemia (Rutherford category 4). The mean lesion length was 10.4±6.51 cm; more than half of the lesions (75, 52.4%) were chronic total occlusions. Calcification was found in 66 (46.2%) lesions. Outcomes at 12 months were compared with DCB safety and effectiveness performance goals derived from the literature. The 30-day primary safety outcome was a composite of freedom from device- and procedure-related mortality, major target limb amputation, and clinically-driven target lesion revascularization (CD-TLR). Results: The primary safety outcome was 99.3% at 30 days. Follow-up compliance at 12 months was 92.6%. Estimated 1-year primary patency using Kaplan-Meier analysis was 90.9% and freedom from CD-TLR was 97.1%. The rate of CD-TLR at 12 months was 2.9%. The Rutherford category status improved significantly (p<0.001) between baseline and 12 months. Conclusion: Results from IN.PACT SFA China demonstrated high rates of patency and low rates of CD-TLR in Chinese subjects through 12 months despite patient and lesion complexity. These data are consistent with the results of other IN.PACT DCB trials.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population ###Abstract: Purpose: To confirm the safety and effectiveness of the IN.PACT Admiral drug-coated balloon (DCB) as a treatment for de novo and native artery restenotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery in Chinese subjects. Materials and Methods: IN.PACT SFA China (ClinicalTrials.gov identifier NCT02118532) was a single-arm, independently adjudicated, prospective, premarket study that enrolled 143 subjects (mean age 66.8±7.7 years; 107 men) at 15 centers. The predominant risk factors were hypertension (104, 72.7%) and diabetes mellitus (66, 46.2%). The majority of subjects were classified as Rutherford category 2 or 3 [69 (48.3%) and 55 (38.5%), respectively]; 19 (13.3%) subjects had critical limb ischemia (Rutherford category 4). The mean lesion length was 10.4±6.51 cm; more than half of the lesions (75, 52.4%) were chronic total occlusions. Calcification was found in 66 (46.2%) lesions. Outcomes at 12 months were compared with DCB safety and effectiveness performance goals derived from the literature. The 30-day primary safety outcome was a composite of freedom from device- and procedure-related mortality, major target limb amputation, and clinically-driven target lesion revascularization (CD-TLR). Results: The primary safety outcome was 99.3% at 30 days. Follow-up compliance at 12 months was 92.6%. Estimated 1-year primary patency using Kaplan-Meier analysis was 90.9% and freedom from CD-TLR was 97.1%. The rate of CD-TLR at 12 months was 2.9%. The Rutherford category status improved significantly (p<0.001) between baseline and 12 months. Conclusion: Results from IN.PACT SFA China demonstrated high rates of patency and low rates of CD-TLR in Chinese subjects through 12 months despite patient and lesion complexity. These data are consistent with the results of other IN.PACT DCB trials. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population ###Abstract: Purpose: To confirm the safety and effectiveness of the IN.PACT Admiral drug-coated balloon (DCB) as a treatment for de novo and native artery restenotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery in Chinese subjects. Materials and Methods: IN.PACT SFA China (ClinicalTrials.gov identifier NCT02118532) was a single-arm, independently adjudicated, prospective, premarket study that enrolled 143 subjects (mean age 66.8±7.7 years; 107 men) at 15 centers. The predominant risk factors were hypertension (104, 72.7%) and diabetes mellitus (66, 46.2%). The majority of subjects were classified as Rutherford category 2 or 3 [69 (48.3%) and 55 (38.5%), respectively]; 19 (13.3%) subjects had critical limb ischemia (Rutherford category 4). The mean lesion length was 10.4±6.51 cm; more than half of the lesions (75, 52.4%) were chronic total occlusions. Calcification was found in 66 (46.2%) lesions. Outcomes at 12 months were compared with DCB safety and effectiveness performance goals derived from the literature. The 30-day primary safety outcome was a composite of freedom from device- and procedure-related mortality, major target limb amputation, and clinically-driven target lesion revascularization (CD-TLR). Results: The primary safety outcome was 99.3% at 30 days. Follow-up compliance at 12 months was 92.6%. Estimated 1-year primary patency using Kaplan-Meier analysis was 90.9% and freedom from CD-TLR was 97.1%. The rate of CD-TLR at 12 months was 2.9%. The Rutherford category status improved significantly (p<0.001) between baseline and 12 months. Conclusion: Results from IN.PACT SFA China demonstrated high rates of patency and low rates of CD-TLR in Chinese subjects through 12 months despite patient and lesion complexity. These data are consistent with the results of other IN.PACT DCB trials. [/INST] Include </s>
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Chen 2020a
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Diffuse Cutaneous Manifestations after Drug-Coated Balloon Angioplasty
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We present here a case of an uncommon cutaneous manifestation after paclitaxel-coated balloon angioplasty. In this case, the patient underwent drug-coated balloon angioplasty for stenosis of a prior vein bypass graft. The patient subsequently developed extensive cutaneous lesions not confined to a single arterial distribution. This case represents a rare complication related to paclitaxel-eluting balloons and provides a cautionary tale as well as clinical acumen for providers in using such devices in their practice.
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Include
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DI3 - Case Report
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Diffuse Cutaneous Manifestations after Drug-Coated Balloon Angioplasty ###Abstract: We present here a case of an uncommon cutaneous manifestation after paclitaxel-coated balloon angioplasty. In this case, the patient underwent drug-coated balloon angioplasty for stenosis of a prior vein bypass graft. The patient subsequently developed extensive cutaneous lesions not confined to a single arterial distribution. This case represents a rare complication related to paclitaxel-eluting balloons and provides a cautionary tale as well as clinical acumen for providers in using such devices in their practice. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Diffuse Cutaneous Manifestations after Drug-Coated Balloon Angioplasty ###Abstract: We present here a case of an uncommon cutaneous manifestation after paclitaxel-coated balloon angioplasty. In this case, the patient underwent drug-coated balloon angioplasty for stenosis of a prior vein bypass graft. The patient subsequently developed extensive cutaneous lesions not confined to a single arterial distribution. This case represents a rare complication related to paclitaxel-eluting balloons and provides a cautionary tale as well as clinical acumen for providers in using such devices in their practice. [/INST] Include </s>
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Chen 2020b
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A systematic review and meta-analysis of the risk of death and patency after application of paclitaxel-coated balloons in the hemodialysis access
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Objective: The comparison between paclitaxel-coated balloon (PCB) angioplasty and plain balloon angioplasty (PBA) for hemodialysis (HD) access stenosis or occlusion has not been well investigated. The objectives of this systematic review and meta-analysis were to compare all-cause mortality, HD access primary patency, and circuit primary patency after endovascular maintenance procedures using PCB angioplasty vs PBA. Methods: MEDLINE, Embase, and Cochrane Databases were systematically searched to identify all the relevant studies on paclitaxel-coated devices for stenosis or thrombosis of HD access. A random effects model was applied to pool the effect measures. Dichotomous data were presented using an odds ratio (OR). Effect data were presented using pooled hazard ratio (HR) with 95% confidence interval (CI). Results: A total of 16 studies were included in this meta-analysis, 12 randomized controlled trials and 4 cohort studies involving 1086 patients who underwent endovascular treatment for HD access stenosis or occlusion. All-cause mortality rates at 6, 12, and 24 months after intervention were similar between the PCB and PBA groups (6 months: OR, 1.06 [95% CI, 0.38-2.96; P =.907; I(2) = 19.2%]; 12 months: OR, 1.20 [95% CI, 0.66-2.16; P =.554; I(2) = 0%]; 24 months: OR, 1.43 [95% CI, 0.83-2.45; P =.195; I(2) = 0%]). There was a significant improvement of primary patency in the PCB group compared with the PBA group (HR, 0.47; 95% CI, 0.33-0.69; P <.001; I(2) = 67.3%). This benefit was consistent with the analysis of randomized controlled trials, whereas cohort studies were excluded. Further subgroup analysis of target lesions demonstrated that primary patency was significantly higher in the PCB group than in the PBA group, not only for arteriovenous fistula (HR, 0.54; 95% CI, 0.30-0.98; P =.041; I(2) = 76.8%) but also for central venous stenosis (HR, 0.39; 95% CI, 0.22-0.71; P =.002; I(2) = 0%). The PCB group was associated with higher 6-month (OR, 0.40; 95% CI, 0.27-0.59; P <.001) and 24-month lesion primary patency (OR, 0.28; 95% CI, 0.11-0.72; P =.009) than PBA and was marginally associated with 12-month lesion primary patency (OR, 0.52; 95% CI, 0.26-1.03; P =.06). Circuit primary patency analysis showed a marginal trend toward better outcome in the PCB group (HR, 0.63; 95% CI, 0.40-1.00) but no statistical significance (P =.052). Conclusions: This systematic review and meta-analysis demonstrated that PCB angioplasty is associated with significantly improved primary patency of arteriovenous fistula and central venous stenosis for HD access maintenance, with no evidence of increasing all-cause mortality based on short-term and midterm follow-up. Further large cohort study is needed to investigate long-term mortality.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: A systematic review and meta-analysis of the risk of death and patency after application of paclitaxel-coated balloons in the hemodialysis access ###Abstract: Objective: The comparison between paclitaxel-coated balloon (PCB) angioplasty and plain balloon angioplasty (PBA) for hemodialysis (HD) access stenosis or occlusion has not been well investigated. The objectives of this systematic review and meta-analysis were to compare all-cause mortality, HD access primary patency, and circuit primary patency after endovascular maintenance procedures using PCB angioplasty vs PBA. Methods: MEDLINE, Embase, and Cochrane Databases were systematically searched to identify all the relevant studies on paclitaxel-coated devices for stenosis or thrombosis of HD access. A random effects model was applied to pool the effect measures. Dichotomous data were presented using an odds ratio (OR). Effect data were presented using pooled hazard ratio (HR) with 95% confidence interval (CI). Results: A total of 16 studies were included in this meta-analysis, 12 randomized controlled trials and 4 cohort studies involving 1086 patients who underwent endovascular treatment for HD access stenosis or occlusion. All-cause mortality rates at 6, 12, and 24 months after intervention were similar between the PCB and PBA groups (6 months: OR, 1.06 [95% CI, 0.38-2.96; P =.907; I(2) = 19.2%]; 12 months: OR, 1.20 [95% CI, 0.66-2.16; P =.554; I(2) = 0%]; 24 months: OR, 1.43 [95% CI, 0.83-2.45; P =.195; I(2) = 0%]). There was a significant improvement of primary patency in the PCB group compared with the PBA group (HR, 0.47; 95% CI, 0.33-0.69; P <.001; I(2) = 67.3%). This benefit was consistent with the analysis of randomized controlled trials, whereas cohort studies were excluded. Further subgroup analysis of target lesions demonstrated that primary patency was significantly higher in the PCB group than in the PBA group, not only for arteriovenous fistula (HR, 0.54; 95% CI, 0.30-0.98; P =.041; I(2) = 76.8%) but also for central venous stenosis (HR, 0.39; 95% CI, 0.22-0.71; P =.002; I(2) = 0%). The PCB group was associated with higher 6-month (OR, 0.40; 95% CI, 0.27-0.59; P <.001) and 24-month lesion primary patency (OR, 0.28; 95% CI, 0.11-0.72; P =.009) than PBA and was marginally associated with 12-month lesion primary patency (OR, 0.52; 95% CI, 0.26-1.03; P =.06). Circuit primary patency analysis showed a marginal trend toward better outcome in the PCB group (HR, 0.63; 95% CI, 0.40-1.00) but no statistical significance (P =.052). Conclusions: This systematic review and meta-analysis demonstrated that PCB angioplasty is associated with significantly improved primary patency of arteriovenous fistula and central venous stenosis for HD access maintenance, with no evidence of increasing all-cause mortality based on short-term and midterm follow-up. Further large cohort study is needed to investigate long-term mortality. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: A systematic review and meta-analysis of the risk of death and patency after application of paclitaxel-coated balloons in the hemodialysis access ###Abstract: Objective: The comparison between paclitaxel-coated balloon (PCB) angioplasty and plain balloon angioplasty (PBA) for hemodialysis (HD) access stenosis or occlusion has not been well investigated. The objectives of this systematic review and meta-analysis were to compare all-cause mortality, HD access primary patency, and circuit primary patency after endovascular maintenance procedures using PCB angioplasty vs PBA. Methods: MEDLINE, Embase, and Cochrane Databases were systematically searched to identify all the relevant studies on paclitaxel-coated devices for stenosis or thrombosis of HD access. A random effects model was applied to pool the effect measures. Dichotomous data were presented using an odds ratio (OR). Effect data were presented using pooled hazard ratio (HR) with 95% confidence interval (CI). Results: A total of 16 studies were included in this meta-analysis, 12 randomized controlled trials and 4 cohort studies involving 1086 patients who underwent endovascular treatment for HD access stenosis or occlusion. All-cause mortality rates at 6, 12, and 24 months after intervention were similar between the PCB and PBA groups (6 months: OR, 1.06 [95% CI, 0.38-2.96; P =.907; I(2) = 19.2%]; 12 months: OR, 1.20 [95% CI, 0.66-2.16; P =.554; I(2) = 0%]; 24 months: OR, 1.43 [95% CI, 0.83-2.45; P =.195; I(2) = 0%]). There was a significant improvement of primary patency in the PCB group compared with the PBA group (HR, 0.47; 95% CI, 0.33-0.69; P <.001; I(2) = 67.3%). This benefit was consistent with the analysis of randomized controlled trials, whereas cohort studies were excluded. Further subgroup analysis of target lesions demonstrated that primary patency was significantly higher in the PCB group than in the PBA group, not only for arteriovenous fistula (HR, 0.54; 95% CI, 0.30-0.98; P =.041; I(2) = 76.8%) but also for central venous stenosis (HR, 0.39; 95% CI, 0.22-0.71; P =.002; I(2) = 0%). The PCB group was associated with higher 6-month (OR, 0.40; 95% CI, 0.27-0.59; P <.001) and 24-month lesion primary patency (OR, 0.28; 95% CI, 0.11-0.72; P =.009) than PBA and was marginally associated with 12-month lesion primary patency (OR, 0.52; 95% CI, 0.26-1.03; P =.06). Circuit primary patency analysis showed a marginal trend toward better outcome in the PCB group (HR, 0.63; 95% CI, 0.40-1.00) but no statistical significance (P =.052). Conclusions: This systematic review and meta-analysis demonstrated that PCB angioplasty is associated with significantly improved primary patency of arteriovenous fistula and central venous stenosis for HD access maintenance, with no evidence of increasing all-cause mortality based on short-term and midterm follow-up. Further large cohort study is needed to investigate long-term mortality. [/INST] Include </s>
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Chou 2018
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Drug-coated balloon vs. Conventional balloon angioplasty in dialysis patients with symptomatic femoropopliteal disease ― A matched comparison
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Background: Recent randomized trials have shown the treatment benefits of use of a drug-coated balloon (DCB) over conventional percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal disease. However, the effectiveness and safety of DCB for dialysis patients remain unclear. Methods and Results: Consecutive dialysis patients, who underwent PTA or DCB for femoropopliteal disease, were assessed retrospectively via 2:1 propensity score matching. Effectiveness and safety endpoints, including binary restenosis, clinically driven target lesion revascularization (CD-TLR), amputations, major adverse cardiac events (MACE), and deaths, were compared between groups. A total of 278 dialysis patients with 339 limbs were eligible for matching: 84 limbs from 77 patients treated with PTA and 46 limbs from 37 patients treated with DCB were compared after matching. Baseline patient and lesion characteristics were not different between groups. Patients treated with DCB had significantly higher rates of freedom from binary restenosis (52.4% vs. 18.6%, P<0.001) and CD-TLR (56.4% vs. 25.9%, P=0.001) at 2 years compared with patients treated with PTA. Both groups had similar outcomes for amputation, MACE, and death. Cox proportional analysis showed that treatment with DCB was independently associated with a reduction of binary restenosis (hazard ratio [HR] 0.368, P=0.001) and CD-TLR (HR 0.390, P=0.004). Conclusions: This study suggested superior 2-year outcomes using DCB compared with PTA and similar safety profiles in dialysis patients with femoropopliteal disease.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon vs. Conventional balloon angioplasty in dialysis patients with symptomatic femoropopliteal disease ― A matched comparison ###Abstract: Background: Recent randomized trials have shown the treatment benefits of use of a drug-coated balloon (DCB) over conventional percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal disease. However, the effectiveness and safety of DCB for dialysis patients remain unclear. Methods and Results: Consecutive dialysis patients, who underwent PTA or DCB for femoropopliteal disease, were assessed retrospectively via 2:1 propensity score matching. Effectiveness and safety endpoints, including binary restenosis, clinically driven target lesion revascularization (CD-TLR), amputations, major adverse cardiac events (MACE), and deaths, were compared between groups. A total of 278 dialysis patients with 339 limbs were eligible for matching: 84 limbs from 77 patients treated with PTA and 46 limbs from 37 patients treated with DCB were compared after matching. Baseline patient and lesion characteristics were not different between groups. Patients treated with DCB had significantly higher rates of freedom from binary restenosis (52.4% vs. 18.6%, P<0.001) and CD-TLR (56.4% vs. 25.9%, P=0.001) at 2 years compared with patients treated with PTA. Both groups had similar outcomes for amputation, MACE, and death. Cox proportional analysis showed that treatment with DCB was independently associated with a reduction of binary restenosis (hazard ratio [HR] 0.368, P=0.001) and CD-TLR (HR 0.390, P=0.004). Conclusions: This study suggested superior 2-year outcomes using DCB compared with PTA and similar safety profiles in dialysis patients with femoropopliteal disease. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon vs. Conventional balloon angioplasty in dialysis patients with symptomatic femoropopliteal disease ― A matched comparison ###Abstract: Background: Recent randomized trials have shown the treatment benefits of use of a drug-coated balloon (DCB) over conventional percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal disease. However, the effectiveness and safety of DCB for dialysis patients remain unclear. Methods and Results: Consecutive dialysis patients, who underwent PTA or DCB for femoropopliteal disease, were assessed retrospectively via 2:1 propensity score matching. Effectiveness and safety endpoints, including binary restenosis, clinically driven target lesion revascularization (CD-TLR), amputations, major adverse cardiac events (MACE), and deaths, were compared between groups. A total of 278 dialysis patients with 339 limbs were eligible for matching: 84 limbs from 77 patients treated with PTA and 46 limbs from 37 patients treated with DCB were compared after matching. Baseline patient and lesion characteristics were not different between groups. Patients treated with DCB had significantly higher rates of freedom from binary restenosis (52.4% vs. 18.6%, P<0.001) and CD-TLR (56.4% vs. 25.9%, P=0.001) at 2 years compared with patients treated with PTA. Both groups had similar outcomes for amputation, MACE, and death. Cox proportional analysis showed that treatment with DCB was independently associated with a reduction of binary restenosis (hazard ratio [HR] 0.368, P=0.001) and CD-TLR (HR 0.390, P=0.004). Conclusions: This study suggested superior 2-year outcomes using DCB compared with PTA and similar safety profiles in dialysis patients with femoropopliteal disease. [/INST] Include </s>
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Cioppa 2012
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Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: One-year single centre clinical results
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Background The use of Directional Atherectomy (DA) for the treatment of calcified femoro-popliteal lesions seems to improve the acute procedural success, however without reducing the long term restenosis rate. Drug coated balloons (DCB) reduced restenosis rate in non heavy calcified lesions. Aim of this study was to demonstrate safety and efficacy of a combined endovascular approach using DA and DCB for the treatment of heavy calcified lesions of the femoro-popliteal tract. Methods: From January 2010 to November 2010, 240 patients underwent PTA of the femoro-popliteal tract in our institution. Within this cohort a total of 30 patients had Life Limiting Claudication (LLC) (n = 18) and 12 a Critical Limb Ischemia (CLI) with baseline Rutherford class 4.2 ± 1.2 underwent PTA of heavy calcified lesions with intravascular ultrasound guided DA and DCB. All procedures have been performed using a distal protection device. Stent implantation was allowed only in case of flow limiting dissections or suboptimal result (residual stenosis > 50%) by visual estimation. After the intervention patients were followed up to 12 months. Results Procedural and clinical success, was achieved in all cases. Bail-out stenting was necessary in only two (6.5%). At twelve month follow up median Rutherford class was 2.2 ± 1.2, ABI was 0.8 ± 0.1 and Limb salvage rate was 100%. Two minor, foot finger or forefoot amputations, were performed to reach complete wound healing and/or preserve deambulation. Duplex control was performed in all the cases (n = 30). In three cases duplex scan showed a significant target lesion restenosis requiring a reintervention (TLR = 10%) leading a total one-year secondary patency rate of 100%. All the three restenosed patients were insulin dependent diabetics and none of them were stented during the procedure. Conclusion The data suggest that combined use of DA and DCB may represent a potential alternative strategy for the treatment of femoro-popliteal severely calcified lesions. These very promising data and the considered hypothesis have to be confirmed in a multicentre randomised trial.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: One-year single centre clinical results ###Abstract: Background The use of Directional Atherectomy (DA) for the treatment of calcified femoro-popliteal lesions seems to improve the acute procedural success, however without reducing the long term restenosis rate. Drug coated balloons (DCB) reduced restenosis rate in non heavy calcified lesions. Aim of this study was to demonstrate safety and efficacy of a combined endovascular approach using DA and DCB for the treatment of heavy calcified lesions of the femoro-popliteal tract. Methods: From January 2010 to November 2010, 240 patients underwent PTA of the femoro-popliteal tract in our institution. Within this cohort a total of 30 patients had Life Limiting Claudication (LLC) (n = 18) and 12 a Critical Limb Ischemia (CLI) with baseline Rutherford class 4.2 ± 1.2 underwent PTA of heavy calcified lesions with intravascular ultrasound guided DA and DCB. All procedures have been performed using a distal protection device. Stent implantation was allowed only in case of flow limiting dissections or suboptimal result (residual stenosis > 50%) by visual estimation. After the intervention patients were followed up to 12 months. Results Procedural and clinical success, was achieved in all cases. Bail-out stenting was necessary in only two (6.5%). At twelve month follow up median Rutherford class was 2.2 ± 1.2, ABI was 0.8 ± 0.1 and Limb salvage rate was 100%. Two minor, foot finger or forefoot amputations, were performed to reach complete wound healing and/or preserve deambulation. Duplex control was performed in all the cases (n = 30). In three cases duplex scan showed a significant target lesion restenosis requiring a reintervention (TLR = 10%) leading a total one-year secondary patency rate of 100%. All the three restenosed patients were insulin dependent diabetics and none of them were stented during the procedure. Conclusion The data suggest that combined use of DA and DCB may represent a potential alternative strategy for the treatment of femoro-popliteal severely calcified lesions. These very promising data and the considered hypothesis have to be confirmed in a multicentre randomised trial. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: One-year single centre clinical results ###Abstract: Background The use of Directional Atherectomy (DA) for the treatment of calcified femoro-popliteal lesions seems to improve the acute procedural success, however without reducing the long term restenosis rate. Drug coated balloons (DCB) reduced restenosis rate in non heavy calcified lesions. Aim of this study was to demonstrate safety and efficacy of a combined endovascular approach using DA and DCB for the treatment of heavy calcified lesions of the femoro-popliteal tract. Methods: From January 2010 to November 2010, 240 patients underwent PTA of the femoro-popliteal tract in our institution. Within this cohort a total of 30 patients had Life Limiting Claudication (LLC) (n = 18) and 12 a Critical Limb Ischemia (CLI) with baseline Rutherford class 4.2 ± 1.2 underwent PTA of heavy calcified lesions with intravascular ultrasound guided DA and DCB. All procedures have been performed using a distal protection device. Stent implantation was allowed only in case of flow limiting dissections or suboptimal result (residual stenosis > 50%) by visual estimation. After the intervention patients were followed up to 12 months. Results Procedural and clinical success, was achieved in all cases. Bail-out stenting was necessary in only two (6.5%). At twelve month follow up median Rutherford class was 2.2 ± 1.2, ABI was 0.8 ± 0.1 and Limb salvage rate was 100%. Two minor, foot finger or forefoot amputations, were performed to reach complete wound healing and/or preserve deambulation. Duplex control was performed in all the cases (n = 30). In three cases duplex scan showed a significant target lesion restenosis requiring a reintervention (TLR = 10%) leading a total one-year secondary patency rate of 100%. All the three restenosed patients were insulin dependent diabetics and none of them were stented during the procedure. Conclusion The data suggest that combined use of DA and DCB may represent a potential alternative strategy for the treatment of femoro-popliteal severely calcified lesions. These very promising data and the considered hypothesis have to be confirmed in a multicentre randomised trial. [/INST] Include </s>
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Cioppa 2017
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Combined use of directional atherectomy and drug-coated balloon for the endovascular treatment of common femoral artery disease: Immediate and one-year outcomes
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Aims: Surgical endarterectomy is the therapy of choice for atherosclerotic common femoral artery (CFA) obstruction. Recently, some large single-centre series have shown encouraging results for the percutaneous treatment of CFA obstructions. The purpose of this study was to evaluate the safety, feasibility, and one-year efficacy of the endovascular treatment of CFA obstructions with combined use of directional atherectomy (DA) and a paclitaxel-coated balloon (DCB). Methods and results: Between January 2012 and July 2014, 30 consecutive patients with severely calcified obstructions of the common femoral artery were treated in our centre using DA followed by DCB dilatation. Provisional stenting was allowed in the case of a suboptimal result. Twenty cases (66%) were isolated CFA interventions, whereas five (17%) and five (17%) also involved inflow and outflow vessels, respectively. Chronic total CFA occlusions (CTO) were recanalised in six cases (20%). Procedural success was achieved in all cases; stenting was needed in three cases (10%). At one year, restenosis and target lesion revascularisation were observed in two of 30 (6.6%) and one of 30 (3.3%) patients, respectively. The secondary patency rate was 96.7%. Conclusions: This single-centre prospective study suggests that the combined use of DA and DCB is a safe and effective alternative to surgery, a treatment option for common femoral artery lesions and provides encouraging results in this setting.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Combined use of directional atherectomy and drug-coated balloon for the endovascular treatment of common femoral artery disease: Immediate and one-year outcomes ###Abstract: Aims: Surgical endarterectomy is the therapy of choice for atherosclerotic common femoral artery (CFA) obstruction. Recently, some large single-centre series have shown encouraging results for the percutaneous treatment of CFA obstructions. The purpose of this study was to evaluate the safety, feasibility, and one-year efficacy of the endovascular treatment of CFA obstructions with combined use of directional atherectomy (DA) and a paclitaxel-coated balloon (DCB). Methods and results: Between January 2012 and July 2014, 30 consecutive patients with severely calcified obstructions of the common femoral artery were treated in our centre using DA followed by DCB dilatation. Provisional stenting was allowed in the case of a suboptimal result. Twenty cases (66%) were isolated CFA interventions, whereas five (17%) and five (17%) also involved inflow and outflow vessels, respectively. Chronic total CFA occlusions (CTO) were recanalised in six cases (20%). Procedural success was achieved in all cases; stenting was needed in three cases (10%). At one year, restenosis and target lesion revascularisation were observed in two of 30 (6.6%) and one of 30 (3.3%) patients, respectively. The secondary patency rate was 96.7%. Conclusions: This single-centre prospective study suggests that the combined use of DA and DCB is a safe and effective alternative to surgery, a treatment option for common femoral artery lesions and provides encouraging results in this setting. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Combined use of directional atherectomy and drug-coated balloon for the endovascular treatment of common femoral artery disease: Immediate and one-year outcomes ###Abstract: Aims: Surgical endarterectomy is the therapy of choice for atherosclerotic common femoral artery (CFA) obstruction. Recently, some large single-centre series have shown encouraging results for the percutaneous treatment of CFA obstructions. The purpose of this study was to evaluate the safety, feasibility, and one-year efficacy of the endovascular treatment of CFA obstructions with combined use of directional atherectomy (DA) and a paclitaxel-coated balloon (DCB). Methods and results: Between January 2012 and July 2014, 30 consecutive patients with severely calcified obstructions of the common femoral artery were treated in our centre using DA followed by DCB dilatation. Provisional stenting was allowed in the case of a suboptimal result. Twenty cases (66%) were isolated CFA interventions, whereas five (17%) and five (17%) also involved inflow and outflow vessels, respectively. Chronic total CFA occlusions (CTO) were recanalised in six cases (20%). Procedural success was achieved in all cases; stenting was needed in three cases (10%). At one year, restenosis and target lesion revascularisation were observed in two of 30 (6.6%) and one of 30 (3.3%) patients, respectively. The secondary patency rate was 96.7%. Conclusions: This single-centre prospective study suggests that the combined use of DA and DCB is a safe and effective alternative to surgery, a treatment option for common femoral artery lesions and provides encouraging results in this setting. [/INST] Include </s>
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Debing 2017
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Paclitaxel-coated versus plain old balloon angioplasty for the treatment of infrainguinal arterial disease in diabetic patients: The Belgian diabetic IN.PACT Trial
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BACKGROUND: Several trials have shown that drug coated balloon (DCB) angioplasty reduce the rates of restenosis in the femoropopliteal artery. This controlled, prospective, multicenter study was designed to demonstrate the efficacy of DCB to inhibit restenosis of the infrainguinal arteries in an exclusive diabetic population. METHODS: Between 2012 and 2014, 106 diabetic patients with symptomatic peripheral arterial disease (PAD) were enrolled at 11 sites in Belgium, 54 treated with DCB angioplasty and 52 treated with plain old balloon angioplasty (POBA). The primary endpoint of the study are the primary patency, mean diameter restenosis and binary restenosis of the treated sites at 6 months without re-intervention in the interim. RESULTS: The 6-month mean diameter restenosis was significantly lower in the DCB arm than in the POBA group (29±36% vs. 46±35%, P=0.032) and the binary (≥50% diameter stenosis) restenosis rate was signicantly lower in DCB patients compared with the POBA's (27% vs. 49%, P=0.03). The primary patency was significantly better in the paclitaxel coated balloon group (73% vs. 51%, P=0.03). The 6-month adverse effects rates were 5.5% in the POBA and 5.7% in the DCB arm. CONCLUSIONS: The treatment of diabetic PAD of the infrainguinal arteries with the DCB provides a bettter primary patency rate compared with the plain old balloon angioplasty. The use of DCB did not increase the number of major adverse clinical events when compared with those seen with the use of the uncoated balloons.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel-coated versus plain old balloon angioplasty for the treatment of infrainguinal arterial disease in diabetic patients: The Belgian diabetic IN.PACT Trial ###Abstract: BACKGROUND: Several trials have shown that drug coated balloon (DCB) angioplasty reduce the rates of restenosis in the femoropopliteal artery. This controlled, prospective, multicenter study was designed to demonstrate the efficacy of DCB to inhibit restenosis of the infrainguinal arteries in an exclusive diabetic population. METHODS: Between 2012 and 2014, 106 diabetic patients with symptomatic peripheral arterial disease (PAD) were enrolled at 11 sites in Belgium, 54 treated with DCB angioplasty and 52 treated with plain old balloon angioplasty (POBA). The primary endpoint of the study are the primary patency, mean diameter restenosis and binary restenosis of the treated sites at 6 months without re-intervention in the interim. RESULTS: The 6-month mean diameter restenosis was significantly lower in the DCB arm than in the POBA group (29±36% vs. 46±35%, P=0.032) and the binary (≥50% diameter stenosis) restenosis rate was signicantly lower in DCB patients compared with the POBA's (27% vs. 49%, P=0.03). The primary patency was significantly better in the paclitaxel coated balloon group (73% vs. 51%, P=0.03). The 6-month adverse effects rates were 5.5% in the POBA and 5.7% in the DCB arm. CONCLUSIONS: The treatment of diabetic PAD of the infrainguinal arteries with the DCB provides a bettter primary patency rate compared with the plain old balloon angioplasty. The use of DCB did not increase the number of major adverse clinical events when compared with those seen with the use of the uncoated balloons. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel-coated versus plain old balloon angioplasty for the treatment of infrainguinal arterial disease in diabetic patients: The Belgian diabetic IN.PACT Trial ###Abstract: BACKGROUND: Several trials have shown that drug coated balloon (DCB) angioplasty reduce the rates of restenosis in the femoropopliteal artery. This controlled, prospective, multicenter study was designed to demonstrate the efficacy of DCB to inhibit restenosis of the infrainguinal arteries in an exclusive diabetic population. METHODS: Between 2012 and 2014, 106 diabetic patients with symptomatic peripheral arterial disease (PAD) were enrolled at 11 sites in Belgium, 54 treated with DCB angioplasty and 52 treated with plain old balloon angioplasty (POBA). The primary endpoint of the study are the primary patency, mean diameter restenosis and binary restenosis of the treated sites at 6 months without re-intervention in the interim. RESULTS: The 6-month mean diameter restenosis was significantly lower in the DCB arm than in the POBA group (29±36% vs. 46±35%, P=0.032) and the binary (≥50% diameter stenosis) restenosis rate was signicantly lower in DCB patients compared with the POBA's (27% vs. 49%, P=0.03). The primary patency was significantly better in the paclitaxel coated balloon group (73% vs. 51%, P=0.03). The 6-month adverse effects rates were 5.5% in the POBA and 5.7% in the DCB arm. CONCLUSIONS: The treatment of diabetic PAD of the infrainguinal arteries with the DCB provides a bettter primary patency rate compared with the plain old balloon angioplasty. The use of DCB did not increase the number of major adverse clinical events when compared with those seen with the use of the uncoated balloons. [/INST] Include </s>
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Donas 2020
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Long-Term Mortality of Matched Patients with Intermittent Claudication Treated by High-Dose Paclitaxel-Coated Balloon Versus Plain Balloon Angioplasty: A Real-World Study
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Purpose: The aim of this study was to assess the long-term mortality of patients treated by the IN.PACT Admiral (Medtronic, Dublin, Ireland) paclitaxel-coated balloon angioplasty (PCBA) compared with standard plain balloon angioplasty (POBA). Materials and Methods: Between January 2013 and January 2014, 238 patients met the inclusion criteria. A two-step analysis was performed. In step 1, the 5-year mortality of the whole patient population was evaluated regardless of possible differences in the patient demographics. In step 2, a matched paired analysis was performed using propensity scores. In addition, for those patients who were treated with PCBA, a possible correlation between dose of paclitaxel and mortality was evaluated. Results: Univariate analysis for the whole group of patients (POBA group A, n = 84 and PCBA group B, n = 121) showed a 5-year mortality rate of 26.2% versus 14.0%, p = 0.02, respectively. Univariate analysis of 77 pairs of propensity score-matched patients resulted in mortality of 26.0% versus 20.8%, p = 0.4, of group A and B, respectively (median follow-up of 61.7 and 61.8 months, p = 0.8, respectively). Comparison of the patients of group B who died versus those who survived showed no correlation between the dose of paclitaxel with increased mortality (p = 0.4). Conclusion: The 5-year findings of the present real-world study showed no increased mortality for the matched patients who underwent PCBA versus POBA. In addition, there was no correlation between mortality and the dose of paclitaxel used.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Long-Term Mortality of Matched Patients with Intermittent Claudication Treated by High-Dose Paclitaxel-Coated Balloon Versus Plain Balloon Angioplasty: A Real-World Study ###Abstract: Purpose: The aim of this study was to assess the long-term mortality of patients treated by the IN.PACT Admiral (Medtronic, Dublin, Ireland) paclitaxel-coated balloon angioplasty (PCBA) compared with standard plain balloon angioplasty (POBA). Materials and Methods: Between January 2013 and January 2014, 238 patients met the inclusion criteria. A two-step analysis was performed. In step 1, the 5-year mortality of the whole patient population was evaluated regardless of possible differences in the patient demographics. In step 2, a matched paired analysis was performed using propensity scores. In addition, for those patients who were treated with PCBA, a possible correlation between dose of paclitaxel and mortality was evaluated. Results: Univariate analysis for the whole group of patients (POBA group A, n = 84 and PCBA group B, n = 121) showed a 5-year mortality rate of 26.2% versus 14.0%, p = 0.02, respectively. Univariate analysis of 77 pairs of propensity score-matched patients resulted in mortality of 26.0% versus 20.8%, p = 0.4, of group A and B, respectively (median follow-up of 61.7 and 61.8 months, p = 0.8, respectively). Comparison of the patients of group B who died versus those who survived showed no correlation between the dose of paclitaxel with increased mortality (p = 0.4). Conclusion: The 5-year findings of the present real-world study showed no increased mortality for the matched patients who underwent PCBA versus POBA. In addition, there was no correlation between mortality and the dose of paclitaxel used. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Long-Term Mortality of Matched Patients with Intermittent Claudication Treated by High-Dose Paclitaxel-Coated Balloon Versus Plain Balloon Angioplasty: A Real-World Study ###Abstract: Purpose: The aim of this study was to assess the long-term mortality of patients treated by the IN.PACT Admiral (Medtronic, Dublin, Ireland) paclitaxel-coated balloon angioplasty (PCBA) compared with standard plain balloon angioplasty (POBA). Materials and Methods: Between January 2013 and January 2014, 238 patients met the inclusion criteria. A two-step analysis was performed. In step 1, the 5-year mortality of the whole patient population was evaluated regardless of possible differences in the patient demographics. In step 2, a matched paired analysis was performed using propensity scores. In addition, for those patients who were treated with PCBA, a possible correlation between dose of paclitaxel and mortality was evaluated. Results: Univariate analysis for the whole group of patients (POBA group A, n = 84 and PCBA group B, n = 121) showed a 5-year mortality rate of 26.2% versus 14.0%, p = 0.02, respectively. Univariate analysis of 77 pairs of propensity score-matched patients resulted in mortality of 26.0% versus 20.8%, p = 0.4, of group A and B, respectively (median follow-up of 61.7 and 61.8 months, p = 0.8, respectively). Comparison of the patients of group B who died versus those who survived showed no correlation between the dose of paclitaxel with increased mortality (p = 0.4). Conclusion: The 5-year findings of the present real-world study showed no increased mortality for the matched patients who underwent PCBA versus POBA. In addition, there was no correlation between mortality and the dose of paclitaxel used. [/INST] Include </s>
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Fanelli 2014a
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Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease
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Purpose: This study was designed to assess the effect of calcium on the efficacy of DEB during revascularization of steno-obstructive SFA lesions. Methods: Sixty patients with de novo lesions of the superficial femoral artery underwent endovascular treatment with drug eluting balloons (DEB). DEB was selected according to vessel reference diameter (1:1). In case of residual stenosis > 50 % or flow-limiting dissection, postdilatation with conventional balloon or provisional stenting was done. Patients were classified into eight groups according to circumferential distribution of calcium on CT-angiography axial images (from 0° to 360°) and to its length (length < or > 3 cm) evaluated with digital-subtraction-angiography. Ankle-brachial index (ABI), late lumen loss (LLL), target lesion revascularization (TLR), primary (PP) and secondary (SP) patency, major adverse events (MAE), and Rutherford shift were evaluated at 1-year follow-up and correlated with the amount of calcium. Results: Revascularization was successful in all cases. Flow-limiting dissection occurred in five cases (8.3 %) with a higher circumferential degree of calcium and solved in three cases with postdilatation and in the other two with provisional stenting. DEB effect was lower in patients with higher degree of calcium (>270° vs. <90°): ABI 0.71 ± 0.07 versus 0.92 ± 0.07; LLL 0.75 ± 0.21 versus 0.45 ± 0.1; PP 50 versus 100 %; SP 50 versus 100 %; TLR 25 versus 0 %; MAE 25 versus 0 %. Conclusions: Calcium represents a barrier to optimal drug absorption. Circumferential distribution seems to be the most influencing factor with the worst effect noticed in 360° calcium presence. © 2014 Springer Science+Business Media and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease ###Abstract: Purpose: This study was designed to assess the effect of calcium on the efficacy of DEB during revascularization of steno-obstructive SFA lesions. Methods: Sixty patients with de novo lesions of the superficial femoral artery underwent endovascular treatment with drug eluting balloons (DEB). DEB was selected according to vessel reference diameter (1:1). In case of residual stenosis > 50 % or flow-limiting dissection, postdilatation with conventional balloon or provisional stenting was done. Patients were classified into eight groups according to circumferential distribution of calcium on CT-angiography axial images (from 0° to 360°) and to its length (length < or > 3 cm) evaluated with digital-subtraction-angiography. Ankle-brachial index (ABI), late lumen loss (LLL), target lesion revascularization (TLR), primary (PP) and secondary (SP) patency, major adverse events (MAE), and Rutherford shift were evaluated at 1-year follow-up and correlated with the amount of calcium. Results: Revascularization was successful in all cases. Flow-limiting dissection occurred in five cases (8.3 %) with a higher circumferential degree of calcium and solved in three cases with postdilatation and in the other two with provisional stenting. DEB effect was lower in patients with higher degree of calcium (>270° vs. <90°): ABI 0.71 ± 0.07 versus 0.92 ± 0.07; LLL 0.75 ± 0.21 versus 0.45 ± 0.1; PP 50 versus 100 %; SP 50 versus 100 %; TLR 25 versus 0 %; MAE 25 versus 0 %. Conclusions: Calcium represents a barrier to optimal drug absorption. Circumferential distribution seems to be the most influencing factor with the worst effect noticed in 360° calcium presence. © 2014 Springer Science+Business Media and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE). [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease ###Abstract: Purpose: This study was designed to assess the effect of calcium on the efficacy of DEB during revascularization of steno-obstructive SFA lesions. Methods: Sixty patients with de novo lesions of the superficial femoral artery underwent endovascular treatment with drug eluting balloons (DEB). DEB was selected according to vessel reference diameter (1:1). In case of residual stenosis > 50 % or flow-limiting dissection, postdilatation with conventional balloon or provisional stenting was done. Patients were classified into eight groups according to circumferential distribution of calcium on CT-angiography axial images (from 0° to 360°) and to its length (length < or > 3 cm) evaluated with digital-subtraction-angiography. Ankle-brachial index (ABI), late lumen loss (LLL), target lesion revascularization (TLR), primary (PP) and secondary (SP) patency, major adverse events (MAE), and Rutherford shift were evaluated at 1-year follow-up and correlated with the amount of calcium. Results: Revascularization was successful in all cases. Flow-limiting dissection occurred in five cases (8.3 %) with a higher circumferential degree of calcium and solved in three cases with postdilatation and in the other two with provisional stenting. DEB effect was lower in patients with higher degree of calcium (>270° vs. <90°): ABI 0.71 ± 0.07 versus 0.92 ± 0.07; LLL 0.75 ± 0.21 versus 0.45 ± 0.1; PP 50 versus 100 %; SP 50 versus 100 %; TLR 25 versus 0 %; MAE 25 versus 0 %. Conclusions: Calcium represents a barrier to optimal drug absorption. Circumferential distribution seems to be the most influencing factor with the worst effect noticed in 360° calcium presence. © 2014 Springer Science+Business Media and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE). [/INST] Include </s>
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Foley 2017
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Mid‐term outcomes of orbital atherectomy combined with drug‐coated balloon angioplasty for treatment of femoropopliteal disease
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Purpose To assess the intraprocedural and mid‐term outcomes of orbital atherectomy (OA) combined with drug‐coated balloon (DCB) angioplasty for the treatment of calcified femoropopliteal disease. Methods In this single‐center cohort, 89 patients (139 lesions) were treated with DCB angioplasty for claudication or critical limb ischemia (CLI). Angiographic characteristics and procedural outcomes were reviewed for patients treated with or without adjunctive OA. Lesion calcification was graded using two previously published scoring systems, the angiographic calcium score (ACS) and the peripheral artery calcification scoring system (PACSS). Results Among 139 lesions, 40 (29%) were treated with OA + DCB. Mean lesion length was 135 ± 100 mm for lesions treated with OA + DCB and 139 ± 100 mm for DCB alone (P = 0.9). Moderate to severe calcification was present in 83% of patients treated with OA, compared to 42% of patients treated with DCB alone (P < 0.001). Lesions treated with OA + DCB were less likely to require bailout stenting (18% vs. 39%, P =0.01). Rates of embolization (0% in OA + DCB vs. 2% in DCB only, P = 0.4), dissection (13% vs. 14%, P = 0.8), and perforation (0%) did not differ significantly between groups. The freedom from TLR at 1 year was 82% in both groups (P = 0.6) while primary patency was 81% in‐patients treated with DCB alone and 77% in‐patients treated with DCB with concomitant OA (P = 0.8). Conclusion In this single‐center analysis of patients undergoing DCB angioplasty for claudication or CLI, OA was most often used for the treatment of severely calcified lesions. These lesions were more likely to be treated with scoring balloons and less likely to require bailout stenting. At 1 year, target lesion revascularization and primary patency was similar in patients treated with and without adjunctive OA, despite the higher lesion complexity among those receiving the combination procedure.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Mid‐term outcomes of orbital atherectomy combined with drug‐coated balloon angioplasty for treatment of femoropopliteal disease ###Abstract: Purpose To assess the intraprocedural and mid‐term outcomes of orbital atherectomy (OA) combined with drug‐coated balloon (DCB) angioplasty for the treatment of calcified femoropopliteal disease. Methods In this single‐center cohort, 89 patients (139 lesions) were treated with DCB angioplasty for claudication or critical limb ischemia (CLI). Angiographic characteristics and procedural outcomes were reviewed for patients treated with or without adjunctive OA. Lesion calcification was graded using two previously published scoring systems, the angiographic calcium score (ACS) and the peripheral artery calcification scoring system (PACSS). Results Among 139 lesions, 40 (29%) were treated with OA + DCB. Mean lesion length was 135 ± 100 mm for lesions treated with OA + DCB and 139 ± 100 mm for DCB alone (P = 0.9). Moderate to severe calcification was present in 83% of patients treated with OA, compared to 42% of patients treated with DCB alone (P < 0.001). Lesions treated with OA + DCB were less likely to require bailout stenting (18% vs. 39%, P =0.01). Rates of embolization (0% in OA + DCB vs. 2% in DCB only, P = 0.4), dissection (13% vs. 14%, P = 0.8), and perforation (0%) did not differ significantly between groups. The freedom from TLR at 1 year was 82% in both groups (P = 0.6) while primary patency was 81% in‐patients treated with DCB alone and 77% in‐patients treated with DCB with concomitant OA (P = 0.8). Conclusion In this single‐center analysis of patients undergoing DCB angioplasty for claudication or CLI, OA was most often used for the treatment of severely calcified lesions. These lesions were more likely to be treated with scoring balloons and less likely to require bailout stenting. At 1 year, target lesion revascularization and primary patency was similar in patients treated with and without adjunctive OA, despite the higher lesion complexity among those receiving the combination procedure. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Mid‐term outcomes of orbital atherectomy combined with drug‐coated balloon angioplasty for treatment of femoropopliteal disease ###Abstract: Purpose To assess the intraprocedural and mid‐term outcomes of orbital atherectomy (OA) combined with drug‐coated balloon (DCB) angioplasty for the treatment of calcified femoropopliteal disease. Methods In this single‐center cohort, 89 patients (139 lesions) were treated with DCB angioplasty for claudication or critical limb ischemia (CLI). Angiographic characteristics and procedural outcomes were reviewed for patients treated with or without adjunctive OA. Lesion calcification was graded using two previously published scoring systems, the angiographic calcium score (ACS) and the peripheral artery calcification scoring system (PACSS). Results Among 139 lesions, 40 (29%) were treated with OA + DCB. Mean lesion length was 135 ± 100 mm for lesions treated with OA + DCB and 139 ± 100 mm for DCB alone (P = 0.9). Moderate to severe calcification was present in 83% of patients treated with OA, compared to 42% of patients treated with DCB alone (P < 0.001). Lesions treated with OA + DCB were less likely to require bailout stenting (18% vs. 39%, P =0.01). Rates of embolization (0% in OA + DCB vs. 2% in DCB only, P = 0.4), dissection (13% vs. 14%, P = 0.8), and perforation (0%) did not differ significantly between groups. The freedom from TLR at 1 year was 82% in both groups (P = 0.6) while primary patency was 81% in‐patients treated with DCB alone and 77% in‐patients treated with DCB with concomitant OA (P = 0.8). Conclusion In this single‐center analysis of patients undergoing DCB angioplasty for claudication or CLI, OA was most often used for the treatment of severely calcified lesions. These lesions were more likely to be treated with scoring balloons and less likely to require bailout stenting. At 1 year, target lesion revascularization and primary patency was similar in patients treated with and without adjunctive OA, despite the higher lesion complexity among those receiving the combination procedure. [/INST] Include </s>
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Giacoppo 2016
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Drug-Coated Balloon Versus Plain Balloon Angioplasty for the Treatment of Femoropopliteal Artery Disease: An Updated Systematic Review and Meta-Analysis of Randomized Clinical Trials
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Objectives This study sought to assess the risk of target lesion revascularization (TLR) and all-cause death at 12 months and at the maximum available follow-up. Secondary objectives included the identification of factors which could have influenced general findings. Background Recently several randomized trials comparing drug-coated balloon (DCB) with conventional plain balloon (PB) for the treatment of femoropopliteal artery disease have been reported, but no updated meta-analyses are available and questions remain surrounding the long-term antirestenotic effectiveness of the 2 therapies. Methods We searched main electronic databases for randomized trials comparing DCB and PB for femoropopliteal artery disease. Random effects models were used to estimate the risk of TLR and all-cause death at 12 months, whereas long-term TLR and death risk were assessed by mixed effects Poisson regression models and incident rates of each outcome per patient-year. Main analyses were supplemented by sensitivity analyses, Bayesian estimates, and trial sequential analysis. Results A total of 8 eligible trials were identified. DCB was associated with a marked 12-month TLR risk reduction as compared with PB (risk ratio: 0.33; 95% confidence interval [CI]: 0.19 to 0.57). The risk of death was similar between groups (risk ratio: 0.96; 95% CI: 0.47 to 1.95). Long-term outcomes assessment showed a reduced incidence of TLR with DCB (0.35; 95% CI: 0.24 to 0.51) and a similar incidence of all-cause death (incidence rate ratio: 1.13; 95% CI: 0.60 to 2.15). Similar findings were observed in Bayesian analyses. Significant heterogeneity was present with evidence of differential efficacy across devices. Trial sequential analysis indicated that available evidence is sufficient to prove superior antirestenotic efficacy of DCB over PB. Conclusions DCB significantly reduces the risk of TLR as compared with PB without any effect on all-cause death. Evidence exists for differential efficacy according to the type of device used. Future trials investigating DCB angioplasty should include potentially more effective comparator therapies.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloon Versus Plain Balloon Angioplasty for the Treatment of Femoropopliteal Artery Disease: An Updated Systematic Review and Meta-Analysis of Randomized Clinical Trials ###Abstract: Objectives This study sought to assess the risk of target lesion revascularization (TLR) and all-cause death at 12 months and at the maximum available follow-up. Secondary objectives included the identification of factors which could have influenced general findings. Background Recently several randomized trials comparing drug-coated balloon (DCB) with conventional plain balloon (PB) for the treatment of femoropopliteal artery disease have been reported, but no updated meta-analyses are available and questions remain surrounding the long-term antirestenotic effectiveness of the 2 therapies. Methods We searched main electronic databases for randomized trials comparing DCB and PB for femoropopliteal artery disease. Random effects models were used to estimate the risk of TLR and all-cause death at 12 months, whereas long-term TLR and death risk were assessed by mixed effects Poisson regression models and incident rates of each outcome per patient-year. Main analyses were supplemented by sensitivity analyses, Bayesian estimates, and trial sequential analysis. Results A total of 8 eligible trials were identified. DCB was associated with a marked 12-month TLR risk reduction as compared with PB (risk ratio: 0.33; 95% confidence interval [CI]: 0.19 to 0.57). The risk of death was similar between groups (risk ratio: 0.96; 95% CI: 0.47 to 1.95). Long-term outcomes assessment showed a reduced incidence of TLR with DCB (0.35; 95% CI: 0.24 to 0.51) and a similar incidence of all-cause death (incidence rate ratio: 1.13; 95% CI: 0.60 to 2.15). Similar findings were observed in Bayesian analyses. Significant heterogeneity was present with evidence of differential efficacy across devices. Trial sequential analysis indicated that available evidence is sufficient to prove superior antirestenotic efficacy of DCB over PB. Conclusions DCB significantly reduces the risk of TLR as compared with PB without any effect on all-cause death. Evidence exists for differential efficacy according to the type of device used. Future trials investigating DCB angioplasty should include potentially more effective comparator therapies. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloon Versus Plain Balloon Angioplasty for the Treatment of Femoropopliteal Artery Disease: An Updated Systematic Review and Meta-Analysis of Randomized Clinical Trials ###Abstract: Objectives This study sought to assess the risk of target lesion revascularization (TLR) and all-cause death at 12 months and at the maximum available follow-up. Secondary objectives included the identification of factors which could have influenced general findings. Background Recently several randomized trials comparing drug-coated balloon (DCB) with conventional plain balloon (PB) for the treatment of femoropopliteal artery disease have been reported, but no updated meta-analyses are available and questions remain surrounding the long-term antirestenotic effectiveness of the 2 therapies. Methods We searched main electronic databases for randomized trials comparing DCB and PB for femoropopliteal artery disease. Random effects models were used to estimate the risk of TLR and all-cause death at 12 months, whereas long-term TLR and death risk were assessed by mixed effects Poisson regression models and incident rates of each outcome per patient-year. Main analyses were supplemented by sensitivity analyses, Bayesian estimates, and trial sequential analysis. Results A total of 8 eligible trials were identified. DCB was associated with a marked 12-month TLR risk reduction as compared with PB (risk ratio: 0.33; 95% confidence interval [CI]: 0.19 to 0.57). The risk of death was similar between groups (risk ratio: 0.96; 95% CI: 0.47 to 1.95). Long-term outcomes assessment showed a reduced incidence of TLR with DCB (0.35; 95% CI: 0.24 to 0.51) and a similar incidence of all-cause death (incidence rate ratio: 1.13; 95% CI: 0.60 to 2.15). Similar findings were observed in Bayesian analyses. Significant heterogeneity was present with evidence of differential efficacy across devices. Trial sequential analysis indicated that available evidence is sufficient to prove superior antirestenotic efficacy of DCB over PB. Conclusions DCB significantly reduces the risk of TLR as compared with PB without any effect on all-cause death. Evidence exists for differential efficacy according to the type of device used. Future trials investigating DCB angioplasty should include potentially more effective comparator therapies. [/INST] Include </s>
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Giannopoulos 2020a
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Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis
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Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic literature search was conducted in PubMed, Scopus, and Cochrane Central up to January 2020 to identify randomized trials and observational studies presenting data on the effectiveness and safety of DCBs in the treatment of femoropopliteal or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was conducted to investigate primary patency and all-cause mortality at 12 months; the results are reported as the odds ratios (ORs) and 95% confidence intervals (CIs). Secondary outcomes were procedural success, bailout stenting, target lesion revascularization (TLR), reocclusion, major amputation, wound healing, and major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion lengths were 121±44 and 135±53 mm, respectively. The overall 12-month all-cause mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal lesions demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, TLR, major amputation, or mortality over 12 months. However, patients with infrapopliteal lesions undergoing DCB angioplasty did have a significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal lesions in patients with CLTI results in acceptable 12-month patency rates, although comparative data have not shown a patency benefit for infrapopliteal lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not significantly different, but studies with longer-term outcomes are necessary to determine any association between DCB use and mortality in patients with CLTI.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis ###Abstract: Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic literature search was conducted in PubMed, Scopus, and Cochrane Central up to January 2020 to identify randomized trials and observational studies presenting data on the effectiveness and safety of DCBs in the treatment of femoropopliteal or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was conducted to investigate primary patency and all-cause mortality at 12 months; the results are reported as the odds ratios (ORs) and 95% confidence intervals (CIs). Secondary outcomes were procedural success, bailout stenting, target lesion revascularization (TLR), reocclusion, major amputation, wound healing, and major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion lengths were 121±44 and 135±53 mm, respectively. The overall 12-month all-cause mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal lesions demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, TLR, major amputation, or mortality over 12 months. However, patients with infrapopliteal lesions undergoing DCB angioplasty did have a significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal lesions in patients with CLTI results in acceptable 12-month patency rates, although comparative data have not shown a patency benefit for infrapopliteal lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not significantly different, but studies with longer-term outcomes are necessary to determine any association between DCB use and mortality in patients with CLTI. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis ###Abstract: Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic literature search was conducted in PubMed, Scopus, and Cochrane Central up to January 2020 to identify randomized trials and observational studies presenting data on the effectiveness and safety of DCBs in the treatment of femoropopliteal or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was conducted to investigate primary patency and all-cause mortality at 12 months; the results are reported as the odds ratios (ORs) and 95% confidence intervals (CIs). Secondary outcomes were procedural success, bailout stenting, target lesion revascularization (TLR), reocclusion, major amputation, wound healing, and major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion lengths were 121±44 and 135±53 mm, respectively. The overall 12-month all-cause mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal lesions demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, TLR, major amputation, or mortality over 12 months. However, patients with infrapopliteal lesions undergoing DCB angioplasty did have a significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal lesions in patients with CLTI results in acceptable 12-month patency rates, although comparative data have not shown a patency benefit for infrapopliteal lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not significantly different, but studies with longer-term outcomes are necessary to determine any association between DCB use and mortality in patients with CLTI. [/INST] Include </s>
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Giannopoulos 2020b
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Comparative 12-month outcomes of drug-coated balloon versus non-drug-coated balloon revascularization strategy in chronic limb threatening ischemia: Results from the XLPAD registry
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Background: Endovascular therapy is often the preferred first treatment option for chronic limb threatening ischemia (CLTI) patients. Drug coated balloons (DCB) reduce restenosis rates compared to percutaneous transluminal angioplasty (PTA), however DCB use has not been studied systematically in patients with CLTI. Thus, the optimal treatment option for these complex lesions remains controversial. Methods: We report on 327 patients with CLTI treated either with DCB (n = 105) or non-DCB (n = 222) for femoropopliteal disease. Data were retrieved from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851). Two DCB types were used at the discretion of the operator: Lutonix® (BARD Peripheral Vascular, Inc., Tempe, AZ, USA) and IN.PACT AdmiralTM (Medtronic, Santa Rosa, CA, USA). Odds ratios and the respective 95% confidence interval were synthesized to examine the association between the two groups in terms of all-cause mortality, target limb repeat endovascular or surgical revascularization, target vessel revascularization (TVR), major and minor amputation at 12 months of follow up. Results: The mean lesion length was 150.0 mm (SD:123.2) and 151.2 mm (SD:108.3) for the DCB and non-DCB group respectively. No difference between the two groups was detected in terms of all-cause mortality (2.86%vs2.7%,p = .94), target limb repeat endovascular or surgical revascularization (16.19%vs12.61%,p = .25), TVR (16.19%vs.11.71%,p = .26) or minor amputation (15.24%vs10.81%,p = .25) at 12 months of follow up. Although a higher incidence of 12 months major amputation was observed in the DCB group (11%vs.4%,p = .01), after adjusting for several risk factors the odds of major amputation were not statistically different between the DCB and non-DCB groups (OR:1.54;95%CI:0.53–4.51;p = .43). Conclusions: Both DCB and non-DCB strategies are effective modalities for revascularization of patients with CLTI. No differences were identified between the DCB and non-DCB group in terms of late outcomes during 12 months of follow up.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Comparative 12-month outcomes of drug-coated balloon versus non-drug-coated balloon revascularization strategy in chronic limb threatening ischemia: Results from the XLPAD registry ###Abstract: Background: Endovascular therapy is often the preferred first treatment option for chronic limb threatening ischemia (CLTI) patients. Drug coated balloons (DCB) reduce restenosis rates compared to percutaneous transluminal angioplasty (PTA), however DCB use has not been studied systematically in patients with CLTI. Thus, the optimal treatment option for these complex lesions remains controversial. Methods: We report on 327 patients with CLTI treated either with DCB (n = 105) or non-DCB (n = 222) for femoropopliteal disease. Data were retrieved from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851). Two DCB types were used at the discretion of the operator: Lutonix® (BARD Peripheral Vascular, Inc., Tempe, AZ, USA) and IN.PACT AdmiralTM (Medtronic, Santa Rosa, CA, USA). Odds ratios and the respective 95% confidence interval were synthesized to examine the association between the two groups in terms of all-cause mortality, target limb repeat endovascular or surgical revascularization, target vessel revascularization (TVR), major and minor amputation at 12 months of follow up. Results: The mean lesion length was 150.0 mm (SD:123.2) and 151.2 mm (SD:108.3) for the DCB and non-DCB group respectively. No difference between the two groups was detected in terms of all-cause mortality (2.86%vs2.7%,p = .94), target limb repeat endovascular or surgical revascularization (16.19%vs12.61%,p = .25), TVR (16.19%vs.11.71%,p = .26) or minor amputation (15.24%vs10.81%,p = .25) at 12 months of follow up. Although a higher incidence of 12 months major amputation was observed in the DCB group (11%vs.4%,p = .01), after adjusting for several risk factors the odds of major amputation were not statistically different between the DCB and non-DCB groups (OR:1.54;95%CI:0.53–4.51;p = .43). Conclusions: Both DCB and non-DCB strategies are effective modalities for revascularization of patients with CLTI. No differences were identified between the DCB and non-DCB group in terms of late outcomes during 12 months of follow up. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Comparative 12-month outcomes of drug-coated balloon versus non-drug-coated balloon revascularization strategy in chronic limb threatening ischemia: Results from the XLPAD registry ###Abstract: Background: Endovascular therapy is often the preferred first treatment option for chronic limb threatening ischemia (CLTI) patients. Drug coated balloons (DCB) reduce restenosis rates compared to percutaneous transluminal angioplasty (PTA), however DCB use has not been studied systematically in patients with CLTI. Thus, the optimal treatment option for these complex lesions remains controversial. Methods: We report on 327 patients with CLTI treated either with DCB (n = 105) or non-DCB (n = 222) for femoropopliteal disease. Data were retrieved from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851). Two DCB types were used at the discretion of the operator: Lutonix® (BARD Peripheral Vascular, Inc., Tempe, AZ, USA) and IN.PACT AdmiralTM (Medtronic, Santa Rosa, CA, USA). Odds ratios and the respective 95% confidence interval were synthesized to examine the association between the two groups in terms of all-cause mortality, target limb repeat endovascular or surgical revascularization, target vessel revascularization (TVR), major and minor amputation at 12 months of follow up. Results: The mean lesion length was 150.0 mm (SD:123.2) and 151.2 mm (SD:108.3) for the DCB and non-DCB group respectively. No difference between the two groups was detected in terms of all-cause mortality (2.86%vs2.7%,p = .94), target limb repeat endovascular or surgical revascularization (16.19%vs12.61%,p = .25), TVR (16.19%vs.11.71%,p = .26) or minor amputation (15.24%vs10.81%,p = .25) at 12 months of follow up. Although a higher incidence of 12 months major amputation was observed in the DCB group (11%vs.4%,p = .01), after adjusting for several risk factors the odds of major amputation were not statistically different between the DCB and non-DCB groups (OR:1.54;95%CI:0.53–4.51;p = .43). Conclusions: Both DCB and non-DCB strategies are effective modalities for revascularization of patients with CLTI. No differences were identified between the DCB and non-DCB group in terms of late outcomes during 12 months of follow up. [/INST] Include </s>
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Goksel 2018
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Midterm results with drug-coated balloons for SFA lesions in patients with CLI: Comparison with conventional bypass surgery
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BACKGROUND: Endovascular treatment of symptomatic peripheral artery disease has gained widespread acceptance. The efficacy and safety of drug-coated balloon (DCB) angioplasty in the setting of critical limb ischemia in comparison to conventional surgery has not been demonstrated. We have compared our results with DCB angioplasty to conventional bypass surgery in patients with critical limb ischemia (CLI). METHODS: A total of 187 patients with CLI treated over a 6-year period between 2006 and 2012 by a single operative team constituted the study population. Between 2006 and 2009, all patients underwent conventional surgery. Between 2009 and 2012, the investigators adopted endovascular approach with the use of IN.PACT Admiral (Medtronic Inc., Santa Rosa, CA, USA). Data collection was achieved prospectively. RESULT S: A total 210 procedures (100 surgery, 110 endovascular) were performed over a 6-year period. A 72% of all bypasses were performed using saphenous vein grafts with above-the-knee bypass as the technique of choice in 80% of the cases. 6-mm DCB was used in 41% of the patients. Procedural success rates (98% vs. 99%, NS) as well as clinical success rates (99% vs. 99%, P=NS) and operative mortality (3.7% vs. 2%, NS) was similar in both groups. Primary patency for DCB vs. bypass groups 91.8% vs. 88.9%, respectively (P=0.31) at 12 months and 82.7% vs. 82.8% at 24 months, respectively (P=0.28). Freedom from clinically-driven target lesion revascularization at 12 months was similar in both groups (87.6% vs. 85%, P=0.33). Primary patency for DCB vs. bypass groups at 24 months was 82.7% vs. 82.8%, respectively (P=0.28). CONCLUSIONS: DCB angioplasty yields comparable results to surgery in the setting of critical ischemia. The efficacy and the safety of DCBs in more complex lesions is to be investigated with randomized trials.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Midterm results with drug-coated balloons for SFA lesions in patients with CLI: Comparison with conventional bypass surgery ###Abstract: BACKGROUND: Endovascular treatment of symptomatic peripheral artery disease has gained widespread acceptance. The efficacy and safety of drug-coated balloon (DCB) angioplasty in the setting of critical limb ischemia in comparison to conventional surgery has not been demonstrated. We have compared our results with DCB angioplasty to conventional bypass surgery in patients with critical limb ischemia (CLI). METHODS: A total of 187 patients with CLI treated over a 6-year period between 2006 and 2012 by a single operative team constituted the study population. Between 2006 and 2009, all patients underwent conventional surgery. Between 2009 and 2012, the investigators adopted endovascular approach with the use of IN.PACT Admiral (Medtronic Inc., Santa Rosa, CA, USA). Data collection was achieved prospectively. RESULT S: A total 210 procedures (100 surgery, 110 endovascular) were performed over a 6-year period. A 72% of all bypasses were performed using saphenous vein grafts with above-the-knee bypass as the technique of choice in 80% of the cases. 6-mm DCB was used in 41% of the patients. Procedural success rates (98% vs. 99%, NS) as well as clinical success rates (99% vs. 99%, P=NS) and operative mortality (3.7% vs. 2%, NS) was similar in both groups. Primary patency for DCB vs. bypass groups 91.8% vs. 88.9%, respectively (P=0.31) at 12 months and 82.7% vs. 82.8% at 24 months, respectively (P=0.28). Freedom from clinically-driven target lesion revascularization at 12 months was similar in both groups (87.6% vs. 85%, P=0.33). Primary patency for DCB vs. bypass groups at 24 months was 82.7% vs. 82.8%, respectively (P=0.28). CONCLUSIONS: DCB angioplasty yields comparable results to surgery in the setting of critical ischemia. The efficacy and the safety of DCBs in more complex lesions is to be investigated with randomized trials. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Midterm results with drug-coated balloons for SFA lesions in patients with CLI: Comparison with conventional bypass surgery ###Abstract: BACKGROUND: Endovascular treatment of symptomatic peripheral artery disease has gained widespread acceptance. The efficacy and safety of drug-coated balloon (DCB) angioplasty in the setting of critical limb ischemia in comparison to conventional surgery has not been demonstrated. We have compared our results with DCB angioplasty to conventional bypass surgery in patients with critical limb ischemia (CLI). METHODS: A total of 187 patients with CLI treated over a 6-year period between 2006 and 2012 by a single operative team constituted the study population. Between 2006 and 2009, all patients underwent conventional surgery. Between 2009 and 2012, the investigators adopted endovascular approach with the use of IN.PACT Admiral (Medtronic Inc., Santa Rosa, CA, USA). Data collection was achieved prospectively. RESULT S: A total 210 procedures (100 surgery, 110 endovascular) were performed over a 6-year period. A 72% of all bypasses were performed using saphenous vein grafts with above-the-knee bypass as the technique of choice in 80% of the cases. 6-mm DCB was used in 41% of the patients. Procedural success rates (98% vs. 99%, NS) as well as clinical success rates (99% vs. 99%, P=NS) and operative mortality (3.7% vs. 2%, NS) was similar in both groups. Primary patency for DCB vs. bypass groups 91.8% vs. 88.9%, respectively (P=0.31) at 12 months and 82.7% vs. 82.8% at 24 months, respectively (P=0.28). Freedom from clinically-driven target lesion revascularization at 12 months was similar in both groups (87.6% vs. 85%, P=0.33). Primary patency for DCB vs. bypass groups at 24 months was 82.7% vs. 82.8%, respectively (P=0.28). CONCLUSIONS: DCB angioplasty yields comparable results to surgery in the setting of critical ischemia. The efficacy and the safety of DCBs in more complex lesions is to be investigated with randomized trials. [/INST] Include </s>
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Golamari 2019
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Shockwave Intravascular Lithotripsy Via Exclusive Pedal Approach for the Treatment of Complicated Peripheral Arterial Disease
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Shockwave intravascular lithotripsy for the treatment of peripheral arterial disease is routinely performed via femoral artery access. In patients with complex femoropopliteal disease, this traditional approach is not feasible. To address this situation, we used an exclusive pedal access approach along with other adjunctive treatments, resulting in a successful outcome. (Level of Difficulty: Advanced.)
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Include
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DI3 - Case Report
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Shockwave Intravascular Lithotripsy Via Exclusive Pedal Approach for the Treatment of Complicated Peripheral Arterial Disease ###Abstract: Shockwave intravascular lithotripsy for the treatment of peripheral arterial disease is routinely performed via femoral artery access. In patients with complex femoropopliteal disease, this traditional approach is not feasible. To address this situation, we used an exclusive pedal access approach along with other adjunctive treatments, resulting in a successful outcome. (Level of Difficulty: Advanced.) [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Shockwave Intravascular Lithotripsy Via Exclusive Pedal Approach for the Treatment of Complicated Peripheral Arterial Disease ###Abstract: Shockwave intravascular lithotripsy for the treatment of peripheral arterial disease is routinely performed via femoral artery access. In patients with complex femoropopliteal disease, this traditional approach is not feasible. To address this situation, we used an exclusive pedal access approach along with other adjunctive treatments, resulting in a successful outcome. (Level of Difficulty: Advanced.) [/INST] Include </s>
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Goldberg 2018
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Pulmonary vein stenosis with collateralization via esophageal varices: Long-term follow-up after successful treatment with drug-eluting stent
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Objective: We describe the long-term follow-up of a child with recurrent hemoptysis due to severe pulmonary vein stenosis decompressing via collaterals to esophageal varices. Design: Case report. Setting: Tertiary children's hospital. Patient: Single child through ages 2- to 11-year old. Interventions: The child underwent cutting balloon angioplasty, bare metal stenting, and implantation of a PTFE-covered stent, all of which failed rapidly. Only after placement of a paclitaxel drug eluting stent did he have prolonged relief from hemoptysis and long-term patency of the treated vein. The stents were serially dilated to keep up with somatic growth of the child, eventually culminating in the need to induce intentional stent fracture. Conclusions: We highlight novel transcatheter techniques to treat this vexing condition, discuss mechanisms of disease treatment and progression, and present the only patient with this rare combination of lesions to have achieved both longstanding pulmonary vein patency and resolution of esophageal varices.
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Include
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DI3 - Case Report
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Pulmonary vein stenosis with collateralization via esophageal varices: Long-term follow-up after successful treatment with drug-eluting stent ###Abstract: Objective: We describe the long-term follow-up of a child with recurrent hemoptysis due to severe pulmonary vein stenosis decompressing via collaterals to esophageal varices. Design: Case report. Setting: Tertiary children's hospital. Patient: Single child through ages 2- to 11-year old. Interventions: The child underwent cutting balloon angioplasty, bare metal stenting, and implantation of a PTFE-covered stent, all of which failed rapidly. Only after placement of a paclitaxel drug eluting stent did he have prolonged relief from hemoptysis and long-term patency of the treated vein. The stents were serially dilated to keep up with somatic growth of the child, eventually culminating in the need to induce intentional stent fracture. Conclusions: We highlight novel transcatheter techniques to treat this vexing condition, discuss mechanisms of disease treatment and progression, and present the only patient with this rare combination of lesions to have achieved both longstanding pulmonary vein patency and resolution of esophageal varices. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Pulmonary vein stenosis with collateralization via esophageal varices: Long-term follow-up after successful treatment with drug-eluting stent ###Abstract: Objective: We describe the long-term follow-up of a child with recurrent hemoptysis due to severe pulmonary vein stenosis decompressing via collaterals to esophageal varices. Design: Case report. Setting: Tertiary children's hospital. Patient: Single child through ages 2- to 11-year old. Interventions: The child underwent cutting balloon angioplasty, bare metal stenting, and implantation of a PTFE-covered stent, all of which failed rapidly. Only after placement of a paclitaxel drug eluting stent did he have prolonged relief from hemoptysis and long-term patency of the treated vein. The stents were serially dilated to keep up with somatic growth of the child, eventually culminating in the need to induce intentional stent fracture. Conclusions: We highlight novel transcatheter techniques to treat this vexing condition, discuss mechanisms of disease treatment and progression, and present the only patient with this rare combination of lesions to have achieved both longstanding pulmonary vein patency and resolution of esophageal varices. [/INST] Include </s>
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Gunnar 2015
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Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial
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Background: Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease.
Methods and results: The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point was primary patency, defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94 ± 4.89 and 8.81 ± 5.12 cm (P=0.82) and 25.8% and 19.5% (P=0.22), respectively. DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA [P=0.10]). There were no device- or procedure-related deaths and no major amputations.
Conclusions: In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial ###Abstract: Background: Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease.
Methods and results: The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point was primary patency, defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94 ± 4.89 and 8.81 ± 5.12 cm (P=0.82) and 25.8% and 19.5% (P=0.22), respectively. DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA [P=0.10]). There were no device- or procedure-related deaths and no major amputations.
Conclusions: In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial ###Abstract: Background: Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease.
Methods and results: The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point was primary patency, defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94 ± 4.89 and 8.81 ± 5.12 cm (P=0.82) and 25.8% and 19.5% (P=0.22), respectively. DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA [P=0.10]). There were no device- or procedure-related deaths and no major amputations.
Conclusions: In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease. [/INST] Include </s>
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Haave 2019
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Treatment of restenosis in radiocephalic arteriovenous hemodialysis fistulas: percutaneous transluminal angioplasty or drug-coated balloon
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Background: Percutaneous transluminal angioplasty (PTA) is an established treatment of arteriovenous fistula (AVF) stenosis. Drug-coated balloons (DCB) are coated with an antiproliferative drug intended to decrease neointimal hyperplasia and restenosis. Purpose: To investigate the patency after treatment of restenosis in radiocephalic AVFs with PTA versus DCB. Material and Methods: A retrospective study comprising 26 patients, recruited from treatment registers, receiving at least one previous PTA and a re-intervention (13 PTAs and 13 DCBs) at the same anatomic location, were observed for 24 months. Patency after re-intervention was compared between the two cohorts. Furthermore, an intra-subject analysis, comparing patency before and after DCB, was performed in the DCB cohort. The Kaplan–Meier method was used to estimate the proportion of stenosis-free patients at different time points after treatment. Results: After 12 and 24 months, the estimated proportions of stenosis-free patients were 61% and 31%, respectively, in the DCB cohort, compared to 40% and 15% in the PTA cohort. In the intra-subject analysis, 15% and 8% of the patients treated with PTA remained stenosis-free after 12 and 24 months, respectively. Patients treated with DCB had significantly longer patency than patients in the PTA cohort (median 16 vs. 5 months, respectively; P = 0.05). Additionally, in the intra-subject analysis, patency after DCB treatment exceeded PTA (median 16 vs. 5 months, respectively; P = 0.01). Conclusion: Our results indicate that DCB angioplasty is associated with significantly improved patency in the treatment of restenosis in radiocephalic AVFs. A longer follow-up or randomized controlled trial is warranted.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Treatment of restenosis in radiocephalic arteriovenous hemodialysis fistulas: percutaneous transluminal angioplasty or drug-coated balloon ###Abstract: Background: Percutaneous transluminal angioplasty (PTA) is an established treatment of arteriovenous fistula (AVF) stenosis. Drug-coated balloons (DCB) are coated with an antiproliferative drug intended to decrease neointimal hyperplasia and restenosis. Purpose: To investigate the patency after treatment of restenosis in radiocephalic AVFs with PTA versus DCB. Material and Methods: A retrospective study comprising 26 patients, recruited from treatment registers, receiving at least one previous PTA and a re-intervention (13 PTAs and 13 DCBs) at the same anatomic location, were observed for 24 months. Patency after re-intervention was compared between the two cohorts. Furthermore, an intra-subject analysis, comparing patency before and after DCB, was performed in the DCB cohort. The Kaplan–Meier method was used to estimate the proportion of stenosis-free patients at different time points after treatment. Results: After 12 and 24 months, the estimated proportions of stenosis-free patients were 61% and 31%, respectively, in the DCB cohort, compared to 40% and 15% in the PTA cohort. In the intra-subject analysis, 15% and 8% of the patients treated with PTA remained stenosis-free after 12 and 24 months, respectively. Patients treated with DCB had significantly longer patency than patients in the PTA cohort (median 16 vs. 5 months, respectively; P = 0.05). Additionally, in the intra-subject analysis, patency after DCB treatment exceeded PTA (median 16 vs. 5 months, respectively; P = 0.01). Conclusion: Our results indicate that DCB angioplasty is associated with significantly improved patency in the treatment of restenosis in radiocephalic AVFs. A longer follow-up or randomized controlled trial is warranted. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Treatment of restenosis in radiocephalic arteriovenous hemodialysis fistulas: percutaneous transluminal angioplasty or drug-coated balloon ###Abstract: Background: Percutaneous transluminal angioplasty (PTA) is an established treatment of arteriovenous fistula (AVF) stenosis. Drug-coated balloons (DCB) are coated with an antiproliferative drug intended to decrease neointimal hyperplasia and restenosis. Purpose: To investigate the patency after treatment of restenosis in radiocephalic AVFs with PTA versus DCB. Material and Methods: A retrospective study comprising 26 patients, recruited from treatment registers, receiving at least one previous PTA and a re-intervention (13 PTAs and 13 DCBs) at the same anatomic location, were observed for 24 months. Patency after re-intervention was compared between the two cohorts. Furthermore, an intra-subject analysis, comparing patency before and after DCB, was performed in the DCB cohort. The Kaplan–Meier method was used to estimate the proportion of stenosis-free patients at different time points after treatment. Results: After 12 and 24 months, the estimated proportions of stenosis-free patients were 61% and 31%, respectively, in the DCB cohort, compared to 40% and 15% in the PTA cohort. In the intra-subject analysis, 15% and 8% of the patients treated with PTA remained stenosis-free after 12 and 24 months, respectively. Patients treated with DCB had significantly longer patency than patients in the PTA cohort (median 16 vs. 5 months, respectively; P = 0.05). Additionally, in the intra-subject analysis, patency after DCB treatment exceeded PTA (median 16 vs. 5 months, respectively; P = 0.01). Conclusion: Our results indicate that DCB angioplasty is associated with significantly improved patency in the treatment of restenosis in radiocephalic AVFs. A longer follow-up or randomized controlled trial is warranted. [/INST] Include </s>
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Hsieh 2019
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Feasibility and mid-term outcomes of drug-coated balloon angioplasty between intermittent claudication and critical limb ischemia in patients with femoropopliteal disease
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Background: The efficacy of drug-coated balloons (DCBs) in critical limb ischemia (CLI) is unclear. To investigate the clinical characteristics and outcomes of DCBs in symptomatic femoropopliteal disease between patients with intermittent claudication (IC) and CLI. Methods: Data were retrospectively collected from three centers in Taiwan on patients who received DCBs for femoropopliteal lesions between March 2013 and June 2017.We compared the clinical characteristics and outcomes regarding binary restenosis, amputation-free survival (AFS), and major adverse limb events (MALEs) between groups. Cox proportional hazards analysis was used to identify predictors of outcome endpoints. Results:We enrolled a total of 200 affected limbs in 174 patients, including 83 limbs in 71 patients with IC and 117 limbs in 103 patients with CLI. Compared to the patients with claudication, those with CLI were older and had higher proportions of medical comorbidities, tissue inflammation, poor runoff, and vessel calcification. The 3-year rates of freedom from binary restenosis (57% vs. 59%, p = 0.781), and MALEs (77% vs. 67%, p = 0.507) were similar between the two groups. However, the 3-year AFS was significantly higher in the IC group compared to the CLI group (91% vs. 73%, p = 0.001). Lesion length and severe calcification independently predicted binary restenosis, and restenotic lesion predicted MALEs. Age, congestive heart failure, and dialysis were independently associated with AFS. Conclusions: Despite advanced limb ischemia and comorbidities, the mid-term outcomes in surviving CLI patients were similar to those in the IC patients after treatment with DCBs for femoropopliteal disease.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Feasibility and mid-term outcomes of drug-coated balloon angioplasty between intermittent claudication and critical limb ischemia in patients with femoropopliteal disease ###Abstract: Background: The efficacy of drug-coated balloons (DCBs) in critical limb ischemia (CLI) is unclear. To investigate the clinical characteristics and outcomes of DCBs in symptomatic femoropopliteal disease between patients with intermittent claudication (IC) and CLI. Methods: Data were retrospectively collected from three centers in Taiwan on patients who received DCBs for femoropopliteal lesions between March 2013 and June 2017.We compared the clinical characteristics and outcomes regarding binary restenosis, amputation-free survival (AFS), and major adverse limb events (MALEs) between groups. Cox proportional hazards analysis was used to identify predictors of outcome endpoints. Results:We enrolled a total of 200 affected limbs in 174 patients, including 83 limbs in 71 patients with IC and 117 limbs in 103 patients with CLI. Compared to the patients with claudication, those with CLI were older and had higher proportions of medical comorbidities, tissue inflammation, poor runoff, and vessel calcification. The 3-year rates of freedom from binary restenosis (57% vs. 59%, p = 0.781), and MALEs (77% vs. 67%, p = 0.507) were similar between the two groups. However, the 3-year AFS was significantly higher in the IC group compared to the CLI group (91% vs. 73%, p = 0.001). Lesion length and severe calcification independently predicted binary restenosis, and restenotic lesion predicted MALEs. Age, congestive heart failure, and dialysis were independently associated with AFS. Conclusions: Despite advanced limb ischemia and comorbidities, the mid-term outcomes in surviving CLI patients were similar to those in the IC patients after treatment with DCBs for femoropopliteal disease. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Feasibility and mid-term outcomes of drug-coated balloon angioplasty between intermittent claudication and critical limb ischemia in patients with femoropopliteal disease ###Abstract: Background: The efficacy of drug-coated balloons (DCBs) in critical limb ischemia (CLI) is unclear. To investigate the clinical characteristics and outcomes of DCBs in symptomatic femoropopliteal disease between patients with intermittent claudication (IC) and CLI. Methods: Data were retrospectively collected from three centers in Taiwan on patients who received DCBs for femoropopliteal lesions between March 2013 and June 2017.We compared the clinical characteristics and outcomes regarding binary restenosis, amputation-free survival (AFS), and major adverse limb events (MALEs) between groups. Cox proportional hazards analysis was used to identify predictors of outcome endpoints. Results:We enrolled a total of 200 affected limbs in 174 patients, including 83 limbs in 71 patients with IC and 117 limbs in 103 patients with CLI. Compared to the patients with claudication, those with CLI were older and had higher proportions of medical comorbidities, tissue inflammation, poor runoff, and vessel calcification. The 3-year rates of freedom from binary restenosis (57% vs. 59%, p = 0.781), and MALEs (77% vs. 67%, p = 0.507) were similar between the two groups. However, the 3-year AFS was significantly higher in the IC group compared to the CLI group (91% vs. 73%, p = 0.001). Lesion length and severe calcification independently predicted binary restenosis, and restenotic lesion predicted MALEs. Age, congestive heart failure, and dialysis were independently associated with AFS. Conclusions: Despite advanced limb ischemia and comorbidities, the mid-term outcomes in surviving CLI patients were similar to those in the IC patients after treatment with DCBs for femoropopliteal disease. [/INST] Include </s>
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Ibrahim 2016
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Downstream Panniculitis Secondary to Drug-Eluting Balloon Angioplasty
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Include
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DI3 - Case Report
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Downstream Panniculitis Secondary to Drug-Eluting Balloon Angioplasty ###Abstract: None [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Downstream Panniculitis Secondary to Drug-Eluting Balloon Angioplasty ###Abstract: None [/INST] Include </s>
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Iida 2018
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Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial
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Purpose: To assess the safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) for the treatment of de novo and native artery restenotic lesions in the superficial femoral and proximal popliteal arteries vs percutaneous transluminal angioplasty (PTA) with an uncoated balloon in a Japanese cohort. Methods: MDT-2113 SFA Japan (ClinicalTrials.gov identifier NCT01947478) is an independently adjudicated, prospective, randomized, single-blinded trial that randomized (2:1) 100 patients (mean age 73.6±7.0 years; 76 men) from 11 Japanese centers to treatment with DCB (n=68) or PTA (n=32). Baseline characteristics were similar between the groups, including mean lesion length (9.15±5.85 and 8.89±6.01 cm for the DCB and PTA groups, respectively). The primary effectiveness outcome was primary patency at 12 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasonography. The safety endpoint was a composite of 30-day device- and procedure-related death and target limb major amputation and clinically-driven target vessel revascularization within 12 months. Results: Patients treated with DCBs exhibited superior 12-month primary patency (89%) compared to patients treated with PTA (48%, p<0.001). The 12-month CD-TLR rate was 3% for DCB vs 19% for PTA (p=0.012). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Quality-of-life measures showed sustained improvement from baseline to 12 months in both groups. Conclusion: Results from the MDT-2113 SFA Japan trial showed superior treatment effect for DCB vs PTA, with excellent patency and low CD-TLR rates. These results are consistent with other IN.PACT SFA DCB trials and demonstrate the safety and effectiveness of this DCB for the treatment of femoropopliteal lesions in this Japanese cohort.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial ###Abstract: Purpose: To assess the safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) for the treatment of de novo and native artery restenotic lesions in the superficial femoral and proximal popliteal arteries vs percutaneous transluminal angioplasty (PTA) with an uncoated balloon in a Japanese cohort. Methods: MDT-2113 SFA Japan (ClinicalTrials.gov identifier NCT01947478) is an independently adjudicated, prospective, randomized, single-blinded trial that randomized (2:1) 100 patients (mean age 73.6±7.0 years; 76 men) from 11 Japanese centers to treatment with DCB (n=68) or PTA (n=32). Baseline characteristics were similar between the groups, including mean lesion length (9.15±5.85 and 8.89±6.01 cm for the DCB and PTA groups, respectively). The primary effectiveness outcome was primary patency at 12 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasonography. The safety endpoint was a composite of 30-day device- and procedure-related death and target limb major amputation and clinically-driven target vessel revascularization within 12 months. Results: Patients treated with DCBs exhibited superior 12-month primary patency (89%) compared to patients treated with PTA (48%, p<0.001). The 12-month CD-TLR rate was 3% for DCB vs 19% for PTA (p=0.012). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Quality-of-life measures showed sustained improvement from baseline to 12 months in both groups. Conclusion: Results from the MDT-2113 SFA Japan trial showed superior treatment effect for DCB vs PTA, with excellent patency and low CD-TLR rates. These results are consistent with other IN.PACT SFA DCB trials and demonstrate the safety and effectiveness of this DCB for the treatment of femoropopliteal lesions in this Japanese cohort. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial ###Abstract: Purpose: To assess the safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) for the treatment of de novo and native artery restenotic lesions in the superficial femoral and proximal popliteal arteries vs percutaneous transluminal angioplasty (PTA) with an uncoated balloon in a Japanese cohort. Methods: MDT-2113 SFA Japan (ClinicalTrials.gov identifier NCT01947478) is an independently adjudicated, prospective, randomized, single-blinded trial that randomized (2:1) 100 patients (mean age 73.6±7.0 years; 76 men) from 11 Japanese centers to treatment with DCB (n=68) or PTA (n=32). Baseline characteristics were similar between the groups, including mean lesion length (9.15±5.85 and 8.89±6.01 cm for the DCB and PTA groups, respectively). The primary effectiveness outcome was primary patency at 12 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasonography. The safety endpoint was a composite of 30-day device- and procedure-related death and target limb major amputation and clinically-driven target vessel revascularization within 12 months. Results: Patients treated with DCBs exhibited superior 12-month primary patency (89%) compared to patients treated with PTA (48%, p<0.001). The 12-month CD-TLR rate was 3% for DCB vs 19% for PTA (p=0.012). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Quality-of-life measures showed sustained improvement from baseline to 12 months in both groups. Conclusion: Results from the MDT-2113 SFA Japan trial showed superior treatment effect for DCB vs PTA, with excellent patency and low CD-TLR rates. These results are consistent with other IN.PACT SFA DCB trials and demonstrate the safety and effectiveness of this DCB for the treatment of femoropopliteal lesions in this Japanese cohort. [/INST] Include </s>
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Iida 2019
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Drug-coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2-year results of the MDT-2113 SFA Japan randomized trial
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Objectives: To assess the longer-term safety and efficacy of the IN.PACT Admiral (MDT-2113) drug-coated balloon (DCB) for the treatment of de novo and non-stented restenotic lesions in the superficial femoral and/or proximal popliteal arteries versus uncoated percutaneous transluminal angioplasty (PTA) in a Japanese cohort. Background: Although DCBs are the newest endovascular strategy for patients with peripheral artery disease presenting with femoropopliteal lesions, there remains a paucity of results in non-Caucasian populations. Methods: IN.PACT SFA Japan is an independently-adjudicated, prospective, multicenter, randomized, single-blinded trial. Endpoints through 2 years included primary patency and a composite safety endpoint of freedom from device- and procedure-related death through 30 days, freedom from target limb major amputation and freedom from clinically-driven target vessel revascularization at 24 months. Results: One hundred patients were assigned by 2:1 randomization to treatment with the IN.PACT Admiral DCB (n = 68) or PTA (n = 32). The groups were well-matched at baseline. Mean lesion length for the DCB and PTA groups were 9.15 ± 5.85 and 8.89 ± 6.01 cm (P = 0.838), respectively. Patients treated with DCB exhibited superior 24-month primary patency compared to PTA (79.8% vs. 46.9%; log rank P < 0.001). The 24-month clinically driven target lesion revascularization rate was 9.1% for DCB versus 20.7% for PTA (P = 0.177). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Conclusions: Two-year results from IN.PACT SFA Japan demonstrated persistently superior patency and low CD-TLR rates through 2 years when compared to uncoated PTA in Japanese patients. These data are consistent with other IN.PACT DCB trials.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2-year results of the MDT-2113 SFA Japan randomized trial ###Abstract: Objectives: To assess the longer-term safety and efficacy of the IN.PACT Admiral (MDT-2113) drug-coated balloon (DCB) for the treatment of de novo and non-stented restenotic lesions in the superficial femoral and/or proximal popliteal arteries versus uncoated percutaneous transluminal angioplasty (PTA) in a Japanese cohort. Background: Although DCBs are the newest endovascular strategy for patients with peripheral artery disease presenting with femoropopliteal lesions, there remains a paucity of results in non-Caucasian populations. Methods: IN.PACT SFA Japan is an independently-adjudicated, prospective, multicenter, randomized, single-blinded trial. Endpoints through 2 years included primary patency and a composite safety endpoint of freedom from device- and procedure-related death through 30 days, freedom from target limb major amputation and freedom from clinically-driven target vessel revascularization at 24 months. Results: One hundred patients were assigned by 2:1 randomization to treatment with the IN.PACT Admiral DCB (n = 68) or PTA (n = 32). The groups were well-matched at baseline. Mean lesion length for the DCB and PTA groups were 9.15 ± 5.85 and 8.89 ± 6.01 cm (P = 0.838), respectively. Patients treated with DCB exhibited superior 24-month primary patency compared to PTA (79.8% vs. 46.9%; log rank P < 0.001). The 24-month clinically driven target lesion revascularization rate was 9.1% for DCB versus 20.7% for PTA (P = 0.177). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Conclusions: Two-year results from IN.PACT SFA Japan demonstrated persistently superior patency and low CD-TLR rates through 2 years when compared to uncoated PTA in Japanese patients. These data are consistent with other IN.PACT DCB trials. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2-year results of the MDT-2113 SFA Japan randomized trial ###Abstract: Objectives: To assess the longer-term safety and efficacy of the IN.PACT Admiral (MDT-2113) drug-coated balloon (DCB) for the treatment of de novo and non-stented restenotic lesions in the superficial femoral and/or proximal popliteal arteries versus uncoated percutaneous transluminal angioplasty (PTA) in a Japanese cohort. Background: Although DCBs are the newest endovascular strategy for patients with peripheral artery disease presenting with femoropopliteal lesions, there remains a paucity of results in non-Caucasian populations. Methods: IN.PACT SFA Japan is an independently-adjudicated, prospective, multicenter, randomized, single-blinded trial. Endpoints through 2 years included primary patency and a composite safety endpoint of freedom from device- and procedure-related death through 30 days, freedom from target limb major amputation and freedom from clinically-driven target vessel revascularization at 24 months. Results: One hundred patients were assigned by 2:1 randomization to treatment with the IN.PACT Admiral DCB (n = 68) or PTA (n = 32). The groups were well-matched at baseline. Mean lesion length for the DCB and PTA groups were 9.15 ± 5.85 and 8.89 ± 6.01 cm (P = 0.838), respectively. Patients treated with DCB exhibited superior 24-month primary patency compared to PTA (79.8% vs. 46.9%; log rank P < 0.001). The 24-month clinically driven target lesion revascularization rate was 9.1% for DCB versus 20.7% for PTA (P = 0.177). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Conclusions: Two-year results from IN.PACT SFA Japan demonstrated persistently superior patency and low CD-TLR rates through 2 years when compared to uncoated PTA in Japanese patients. These data are consistent with other IN.PACT DCB trials. [/INST] Include </s>
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Irani 2018
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Hemodialysis Arteriovenous Fistula and Graft Stenoses: Randomized Trial Comparing Drug-eluting Balloon Angioplasty with Conventional Angioplasty
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Purpose To compare lesion primary patency and restenosis rates between drug-eluting balloon (DEB) percutaneous transluminal angioplasty (PTA) and conventional balloon PTA (cPTA) in the treatment of arteriovenous fistula (AVF) and arteriovenous graft (AVG) stenosis. Materials and Methods In this prospective study, 119 participants (mean age, 59.2 years; 79 men, 40 women) with failing AVFs (n = 98) or AVGs (n = 21) were randomly assigned to undergo either DEB PTA (n = 59) or cPTA (n = 60) from January 2012 to May 2013. Primary end points were lesion primary patency and restenosis rates at 6 months; secondary outcomes were anatomic and clinical success after PTA, circuit primary patency at 6 months and 1 year, and lesion primary patency at 1 year. Statistical analysis was performed by using the Kaplan-Meier product limit estimator, and hazard ratio was calculated by using Cox proportional hazards regression. Complication rates were assessed in both groups. Results Estimated lesion primary patency in the DEB PTA and cPTA arms was 0.81 and 0.61, respectively, at 6 months (P = .03) and 0.51 and 0.34, respectively, at 1 year (P = .04). Estimated circuit primary patency in the DEB PTA and cPTA arms was 0.76 and 0.56, respectively, at 6 months (P = .048) and 0.45 and 0.32, respectively, at 1 year (P = .16). Restenosis rate was 34.0% (16 of 47) for DEB PTA and 62.9% (22 of 35) for cPTA at 6 months (P = .01). No major complications were noted. Conclusion Drug-eluting balloon angioplasty was effective in prolonging lesion primary patency of dialysis access stenoses at 6 months and 1 year.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Hemodialysis Arteriovenous Fistula and Graft Stenoses: Randomized Trial Comparing Drug-eluting Balloon Angioplasty with Conventional Angioplasty ###Abstract: Purpose To compare lesion primary patency and restenosis rates between drug-eluting balloon (DEB) percutaneous transluminal angioplasty (PTA) and conventional balloon PTA (cPTA) in the treatment of arteriovenous fistula (AVF) and arteriovenous graft (AVG) stenosis. Materials and Methods In this prospective study, 119 participants (mean age, 59.2 years; 79 men, 40 women) with failing AVFs (n = 98) or AVGs (n = 21) were randomly assigned to undergo either DEB PTA (n = 59) or cPTA (n = 60) from January 2012 to May 2013. Primary end points were lesion primary patency and restenosis rates at 6 months; secondary outcomes were anatomic and clinical success after PTA, circuit primary patency at 6 months and 1 year, and lesion primary patency at 1 year. Statistical analysis was performed by using the Kaplan-Meier product limit estimator, and hazard ratio was calculated by using Cox proportional hazards regression. Complication rates were assessed in both groups. Results Estimated lesion primary patency in the DEB PTA and cPTA arms was 0.81 and 0.61, respectively, at 6 months (P = .03) and 0.51 and 0.34, respectively, at 1 year (P = .04). Estimated circuit primary patency in the DEB PTA and cPTA arms was 0.76 and 0.56, respectively, at 6 months (P = .048) and 0.45 and 0.32, respectively, at 1 year (P = .16). Restenosis rate was 34.0% (16 of 47) for DEB PTA and 62.9% (22 of 35) for cPTA at 6 months (P = .01). No major complications were noted. Conclusion Drug-eluting balloon angioplasty was effective in prolonging lesion primary patency of dialysis access stenoses at 6 months and 1 year. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Hemodialysis Arteriovenous Fistula and Graft Stenoses: Randomized Trial Comparing Drug-eluting Balloon Angioplasty with Conventional Angioplasty ###Abstract: Purpose To compare lesion primary patency and restenosis rates between drug-eluting balloon (DEB) percutaneous transluminal angioplasty (PTA) and conventional balloon PTA (cPTA) in the treatment of arteriovenous fistula (AVF) and arteriovenous graft (AVG) stenosis. Materials and Methods In this prospective study, 119 participants (mean age, 59.2 years; 79 men, 40 women) with failing AVFs (n = 98) or AVGs (n = 21) were randomly assigned to undergo either DEB PTA (n = 59) or cPTA (n = 60) from January 2012 to May 2013. Primary end points were lesion primary patency and restenosis rates at 6 months; secondary outcomes were anatomic and clinical success after PTA, circuit primary patency at 6 months and 1 year, and lesion primary patency at 1 year. Statistical analysis was performed by using the Kaplan-Meier product limit estimator, and hazard ratio was calculated by using Cox proportional hazards regression. Complication rates were assessed in both groups. Results Estimated lesion primary patency in the DEB PTA and cPTA arms was 0.81 and 0.61, respectively, at 6 months (P = .03) and 0.51 and 0.34, respectively, at 1 year (P = .04). Estimated circuit primary patency in the DEB PTA and cPTA arms was 0.76 and 0.56, respectively, at 6 months (P = .048) and 0.45 and 0.32, respectively, at 1 year (P = .16). Restenosis rate was 34.0% (16 of 47) for DEB PTA and 62.9% (22 of 35) for cPTA at 6 months (P = .01). No major complications were noted. Conclusion Drug-eluting balloon angioplasty was effective in prolonging lesion primary patency of dialysis access stenoses at 6 months and 1 year. [/INST] Include </s>
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Jaldin 2018
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Drug-coated balloon used to treat in-stent restenosis of the renal artery
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During recent years, drug-coated balloons (DCBs) have emerged as a promising therapeutic option. DCBs directly transfer antiproliferative drugs to the arterial wall in order to decrease myointimal hyperplasia. We describe a case of de novo renal artery in-stent restenosis (ISR) treated with drug-coated balloon angioplasty with acceptable short-term results, achieving blood pressure control using fewer antihypertensive agents. The experience and results obtained with DCBs in other territories could suggest and justify use of this technology in renal artery ISR.
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Include
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DI3 - Case Report
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon used to treat in-stent restenosis of the renal artery ###Abstract: During recent years, drug-coated balloons (DCBs) have emerged as a promising therapeutic option. DCBs directly transfer antiproliferative drugs to the arterial wall in order to decrease myointimal hyperplasia. We describe a case of de novo renal artery in-stent restenosis (ISR) treated with drug-coated balloon angioplasty with acceptable short-term results, achieving blood pressure control using fewer antihypertensive agents. The experience and results obtained with DCBs in other territories could suggest and justify use of this technology in renal artery ISR. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon used to treat in-stent restenosis of the renal artery ###Abstract: During recent years, drug-coated balloons (DCBs) have emerged as a promising therapeutic option. DCBs directly transfer antiproliferative drugs to the arterial wall in order to decrease myointimal hyperplasia. We describe a case of de novo renal artery in-stent restenosis (ISR) treated with drug-coated balloon angioplasty with acceptable short-term results, achieving blood pressure control using fewer antihypertensive agents. The experience and results obtained with DCBs in other territories could suggest and justify use of this technology in renal artery ISR. [/INST] Include </s>
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Jang 2015
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Feasibility and Clinical Outcomes of Peripheral Drug-Coated Balloon in High-Risk Patients with Femoropopliteal Disease
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Background Clinical outcomes of the drug-coated balloon (DCB) procedure in high-risk patients with femoropopliteal (FP) disease have not been investigated sufficiently. Methods This retrospective, single-center study analyzed 87 patients (39% dialysis) and 97 affected legs (64% critical limb ischemia [CLI]) that underwent DCB for symptomatic FP disease from March 2013 to September 2014. Risk stratification was based on FeDCLIP (female, diabetes, dialysis, CLI, lesion length >150 mm and poor runoff) score. The DCB outcomes among the different risk groups were compared and factors predicting restenosis were analyzed during follow-up. Results Most of study participants (84%) were moderate to high-risk patients. The procedural success rate was 100% and the 30-day major adverse vascular event rate was 2.1%. The mean lesion length was 178 ± 106 mm and the mean follow-up time was 428 ± 145 (range 50 782) days. The binary restenosis-free and clinically driven target lesion revascularization (CD-TLR)-free rates at 12 months were 77.5% and 84.3%, respectively, for all participants. No significant differences were observed in 1-year binary restenosis and CD-TLR rates in the low-, moderate-, and high-risk groups (60%, 84%, and 73%: p = 0.396; 78%, 89%, and 80%: p = 0.635, respectively). In multivariate analysis, lesion length >150 mm (Hazard ratio [HR]: 8.00, 95% confidence interval (CI) 1.12 to 55.6, p = 0.038) and Rutherford class 6 (HR: 7.09, 95% CI, 1.15 to 43.5, p = 0.034) were identified as independent predictors of binary restenosis. Conclusions Despite general comorbidities and advanced limb ischemia, 1-year outcomes of DCB in high-risk patients with FP disease were effective. The DCB procedure holds promise to improve vessel patency; however, lesion length >150 mm and major tissue loss were independent predictors for binary restenosis after the treatment.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Feasibility and Clinical Outcomes of Peripheral Drug-Coated Balloon in High-Risk Patients with Femoropopliteal Disease ###Abstract: Background Clinical outcomes of the drug-coated balloon (DCB) procedure in high-risk patients with femoropopliteal (FP) disease have not been investigated sufficiently. Methods This retrospective, single-center study analyzed 87 patients (39% dialysis) and 97 affected legs (64% critical limb ischemia [CLI]) that underwent DCB for symptomatic FP disease from March 2013 to September 2014. Risk stratification was based on FeDCLIP (female, diabetes, dialysis, CLI, lesion length >150 mm and poor runoff) score. The DCB outcomes among the different risk groups were compared and factors predicting restenosis were analyzed during follow-up. Results Most of study participants (84%) were moderate to high-risk patients. The procedural success rate was 100% and the 30-day major adverse vascular event rate was 2.1%. The mean lesion length was 178 ± 106 mm and the mean follow-up time was 428 ± 145 (range 50 782) days. The binary restenosis-free and clinically driven target lesion revascularization (CD-TLR)-free rates at 12 months were 77.5% and 84.3%, respectively, for all participants. No significant differences were observed in 1-year binary restenosis and CD-TLR rates in the low-, moderate-, and high-risk groups (60%, 84%, and 73%: p = 0.396; 78%, 89%, and 80%: p = 0.635, respectively). In multivariate analysis, lesion length >150 mm (Hazard ratio [HR]: 8.00, 95% confidence interval (CI) 1.12 to 55.6, p = 0.038) and Rutherford class 6 (HR: 7.09, 95% CI, 1.15 to 43.5, p = 0.034) were identified as independent predictors of binary restenosis. Conclusions Despite general comorbidities and advanced limb ischemia, 1-year outcomes of DCB in high-risk patients with FP disease were effective. The DCB procedure holds promise to improve vessel patency; however, lesion length >150 mm and major tissue loss were independent predictors for binary restenosis after the treatment. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Feasibility and Clinical Outcomes of Peripheral Drug-Coated Balloon in High-Risk Patients with Femoropopliteal Disease ###Abstract: Background Clinical outcomes of the drug-coated balloon (DCB) procedure in high-risk patients with femoropopliteal (FP) disease have not been investigated sufficiently. Methods This retrospective, single-center study analyzed 87 patients (39% dialysis) and 97 affected legs (64% critical limb ischemia [CLI]) that underwent DCB for symptomatic FP disease from March 2013 to September 2014. Risk stratification was based on FeDCLIP (female, diabetes, dialysis, CLI, lesion length >150 mm and poor runoff) score. The DCB outcomes among the different risk groups were compared and factors predicting restenosis were analyzed during follow-up. Results Most of study participants (84%) were moderate to high-risk patients. The procedural success rate was 100% and the 30-day major adverse vascular event rate was 2.1%. The mean lesion length was 178 ± 106 mm and the mean follow-up time was 428 ± 145 (range 50 782) days. The binary restenosis-free and clinically driven target lesion revascularization (CD-TLR)-free rates at 12 months were 77.5% and 84.3%, respectively, for all participants. No significant differences were observed in 1-year binary restenosis and CD-TLR rates in the low-, moderate-, and high-risk groups (60%, 84%, and 73%: p = 0.396; 78%, 89%, and 80%: p = 0.635, respectively). In multivariate analysis, lesion length >150 mm (Hazard ratio [HR]: 8.00, 95% confidence interval (CI) 1.12 to 55.6, p = 0.038) and Rutherford class 6 (HR: 7.09, 95% CI, 1.15 to 43.5, p = 0.034) were identified as independent predictors of binary restenosis. Conclusions Despite general comorbidities and advanced limb ischemia, 1-year outcomes of DCB in high-risk patients with FP disease were effective. The DCB procedure holds promise to improve vessel patency; however, lesion length >150 mm and major tissue loss were independent predictors for binary restenosis after the treatment. [/INST] Include </s>
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Jang 2017
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Clinical outcomes of repetition of drug-coated balloon for femoropopliteal restenosis after drug-coated balloon treatment
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Background: To compare the clinical outcomes of patients undergoing repeated drug-coated balloon (DCB) treatment for femoropopliteal (FP) DCB restenosis with those of patients without repetition-DCB. Methods and Results: From March 2013 to September 2014, 102 patients (118 affected legs) underwent DCB for symptomatic FP disease; 47 patients had restenosis, and 37 underwent reintervention over a 45-month follow-up. We compared the outcomes of repetition-DCB for DCB restenosis with those of patients without repetition. The baseline patient and lesion characteristics were similar between groups. The mean lesion length was 200.8±113.1 and 195.2±134.6 mm, P=0.894, respectively. In addition, the procedural and follow-up outcomes were not different. The rates of freedom from binary restenosis (70% vs. 14%, P=0.001) and clinically driven target lesion revascularization (CD-TLR) (78% vs. 38%, P=0.026) at 1 year were statistically different between groups. Cox regression analysis showed that repetition of DCB was the only predictor for freedom from binary restenosis (hazard ratio [HR]: 6.15, 95% confidence interval (CI) 1.60 to 23.6, P=0.008) and CD-TLR (HR: 5.37, 95% CI 1.32-22.0, P=0.019). Conclusions: For FP DCB restenosis, repetition of DCB can potentially improve vessel patency and significantly reduce the need for reintervention compared with conventional treatment. However, these observations require further confirmation in larger scale studies.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Clinical outcomes of repetition of drug-coated balloon for femoropopliteal restenosis after drug-coated balloon treatment ###Abstract: Background: To compare the clinical outcomes of patients undergoing repeated drug-coated balloon (DCB) treatment for femoropopliteal (FP) DCB restenosis with those of patients without repetition-DCB. Methods and Results: From March 2013 to September 2014, 102 patients (118 affected legs) underwent DCB for symptomatic FP disease; 47 patients had restenosis, and 37 underwent reintervention over a 45-month follow-up. We compared the outcomes of repetition-DCB for DCB restenosis with those of patients without repetition. The baseline patient and lesion characteristics were similar between groups. The mean lesion length was 200.8±113.1 and 195.2±134.6 mm, P=0.894, respectively. In addition, the procedural and follow-up outcomes were not different. The rates of freedom from binary restenosis (70% vs. 14%, P=0.001) and clinically driven target lesion revascularization (CD-TLR) (78% vs. 38%, P=0.026) at 1 year were statistically different between groups. Cox regression analysis showed that repetition of DCB was the only predictor for freedom from binary restenosis (hazard ratio [HR]: 6.15, 95% confidence interval (CI) 1.60 to 23.6, P=0.008) and CD-TLR (HR: 5.37, 95% CI 1.32-22.0, P=0.019). Conclusions: For FP DCB restenosis, repetition of DCB can potentially improve vessel patency and significantly reduce the need for reintervention compared with conventional treatment. However, these observations require further confirmation in larger scale studies. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Clinical outcomes of repetition of drug-coated balloon for femoropopliteal restenosis after drug-coated balloon treatment ###Abstract: Background: To compare the clinical outcomes of patients undergoing repeated drug-coated balloon (DCB) treatment for femoropopliteal (FP) DCB restenosis with those of patients without repetition-DCB. Methods and Results: From March 2013 to September 2014, 102 patients (118 affected legs) underwent DCB for symptomatic FP disease; 47 patients had restenosis, and 37 underwent reintervention over a 45-month follow-up. We compared the outcomes of repetition-DCB for DCB restenosis with those of patients without repetition. The baseline patient and lesion characteristics were similar between groups. The mean lesion length was 200.8±113.1 and 195.2±134.6 mm, P=0.894, respectively. In addition, the procedural and follow-up outcomes were not different. The rates of freedom from binary restenosis (70% vs. 14%, P=0.001) and clinically driven target lesion revascularization (CD-TLR) (78% vs. 38%, P=0.026) at 1 year were statistically different between groups. Cox regression analysis showed that repetition of DCB was the only predictor for freedom from binary restenosis (hazard ratio [HR]: 6.15, 95% confidence interval (CI) 1.60 to 23.6, P=0.008) and CD-TLR (HR: 5.37, 95% CI 1.32-22.0, P=0.019). Conclusions: For FP DCB restenosis, repetition of DCB can potentially improve vessel patency and significantly reduce the need for reintervention compared with conventional treatment. However, these observations require further confirmation in larger scale studies. [/INST] Include </s>
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Katsanos 2012
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Paclitaxel-Coated Balloon Angioplasty vs. Plain Balloon Dilation for the Treatment of Failing Dialysis Access: 6-Month Interim Results From a Prospective Randomized Controlled Trial
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Purpose To report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG). Methods The enrollment criteria for this non-inferiority hypothesis trial included clinical signs of failing dialysis access with angiographic documentation of a significant venous stenotic lesion in patients with AVF or AVG circuits. From March to December 2010, 40 patients (29 men; mean age 64.1±14.3 years) were randomized to undergo either PCB dilation (n=20) or standard BA (n=20) of a stenosed venous outflow lesion. Regular angiographic follow-up was scheduled bimonthly. Study outcome measures included device success (<30% residual stenosis without postdilation), procedural success (<30% residual stenosis), and primary patency of the treated lesion (<50% angiographic restenosis and no need for any interim repeat procedures). Results
Baseline and procedural variables were comparably distributed between both groups. Device success was 9/20 (45%) for the PCB device vs. 20/20 (100%) for standard control BA (p<0.001). Procedural success was 100% in both groups after further high-pressure post-dilation as necessary. There were no major or minor complications in either group. At 6 months, cumulative target lesion primary patency was significantly higher after PCB application (70% in PCB group vs. 25% in BA group, p<0.001; HR 0.30, 95% CI 0.12 to 0.71, p<0.006). Conclusion PCB angioplasty improves patency after angioplasty of venous stenoses of failing vascular access used for dialysis.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel-Coated Balloon Angioplasty vs. Plain Balloon Dilation for the Treatment of Failing Dialysis Access: 6-Month Interim Results From a Prospective Randomized Controlled Trial ###Abstract: Purpose To report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG). Methods The enrollment criteria for this non-inferiority hypothesis trial included clinical signs of failing dialysis access with angiographic documentation of a significant venous stenotic lesion in patients with AVF or AVG circuits. From March to December 2010, 40 patients (29 men; mean age 64.1±14.3 years) were randomized to undergo either PCB dilation (n=20) or standard BA (n=20) of a stenosed venous outflow lesion. Regular angiographic follow-up was scheduled bimonthly. Study outcome measures included device success (<30% residual stenosis without postdilation), procedural success (<30% residual stenosis), and primary patency of the treated lesion (<50% angiographic restenosis and no need for any interim repeat procedures). Results
Baseline and procedural variables were comparably distributed between both groups. Device success was 9/20 (45%) for the PCB device vs. 20/20 (100%) for standard control BA (p<0.001). Procedural success was 100% in both groups after further high-pressure post-dilation as necessary. There were no major or minor complications in either group. At 6 months, cumulative target lesion primary patency was significantly higher after PCB application (70% in PCB group vs. 25% in BA group, p<0.001; HR 0.30, 95% CI 0.12 to 0.71, p<0.006). Conclusion PCB angioplasty improves patency after angioplasty of venous stenoses of failing vascular access used for dialysis. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel-Coated Balloon Angioplasty vs. Plain Balloon Dilation for the Treatment of Failing Dialysis Access: 6-Month Interim Results From a Prospective Randomized Controlled Trial ###Abstract: Purpose To report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG). Methods The enrollment criteria for this non-inferiority hypothesis trial included clinical signs of failing dialysis access with angiographic documentation of a significant venous stenotic lesion in patients with AVF or AVG circuits. From March to December 2010, 40 patients (29 men; mean age 64.1±14.3 years) were randomized to undergo either PCB dilation (n=20) or standard BA (n=20) of a stenosed venous outflow lesion. Regular angiographic follow-up was scheduled bimonthly. Study outcome measures included device success (<30% residual stenosis without postdilation), procedural success (<30% residual stenosis), and primary patency of the treated lesion (<50% angiographic restenosis and no need for any interim repeat procedures). Results
Baseline and procedural variables were comparably distributed between both groups. Device success was 9/20 (45%) for the PCB device vs. 20/20 (100%) for standard control BA (p<0.001). Procedural success was 100% in both groups after further high-pressure post-dilation as necessary. There were no major or minor complications in either group. At 6 months, cumulative target lesion primary patency was significantly higher after PCB application (70% in PCB group vs. 25% in BA group, p<0.001; HR 0.30, 95% CI 0.12 to 0.71, p<0.006). Conclusion PCB angioplasty improves patency after angioplasty of venous stenoses of failing vascular access used for dialysis. [/INST] Include </s>
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Katsanos 2018
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Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: A systematic review and meta-analysis of randomized controlled trials
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Background-Several randomized controlled trials (RCTs) have already shown that paclitaxel-coated balloons and stents significantly reduce the rates of vessel restenosis and target lesion revascularization after lower extremity interventions. Methods and Results-A systematic review and meta-analysis of RCTs investigating paclitaxel-coated devices in the femoral and/ or popliteal arteries was performed. The primary safety measure was all-cause patient death. Risk ratios and risk differences were pooled with a random effects model. In all, 28 RCTs with 4663 patients (89% intermittent claudication) were analyzed. All-cause patient death at 1 year (28 RCTs with 4432 cases) was similar between paclitaxel-coated devices and control arms (2.3% versus 2.3% crude risk of death; risk ratio, 1.08; 95% CI, 0.72-1.61). All-cause death at 2 years (12 RCTs with 2316 cases) was significantly increased in the case of paclitaxel versus control (7.2% versus 3.8% crude risk of death; risk ratio, 1.68; 95% CI, 1.15- 2.47; -number-needed-to-harm, 29 patients [95% CI, 19-59]). All-cause death up to 5 years (3 RCTs with 863 cases) increased further in the case of paclitaxel (14.7% versus 8.1% crude risk of death; risk ratio, 1.93; 95% CI, 1.27-2.93; -number-needed-toharm, 14 patients [95% CI, 9-32]). Meta-regression showed a significant relationship between exposure to paclitaxel (dose-time product) and absolute risk of death (0.4±0.1% excess risk of death per paclitaxel mg-year; P<0.001). Trial sequential analysis excluded false-positive findings with 99% certainty (2-sided a, 1.0%). Conclusions-There is increased risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the lower limbs. Further investigations are urgently warranted. Clinical Trial Registration-URL: www.crd.york.ac.uk/PROSPERO. Unique identifier: CRD42018099447.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: A systematic review and meta-analysis of randomized controlled trials ###Abstract: Background-Several randomized controlled trials (RCTs) have already shown that paclitaxel-coated balloons and stents significantly reduce the rates of vessel restenosis and target lesion revascularization after lower extremity interventions. Methods and Results-A systematic review and meta-analysis of RCTs investigating paclitaxel-coated devices in the femoral and/ or popliteal arteries was performed. The primary safety measure was all-cause patient death. Risk ratios and risk differences were pooled with a random effects model. In all, 28 RCTs with 4663 patients (89% intermittent claudication) were analyzed. All-cause patient death at 1 year (28 RCTs with 4432 cases) was similar between paclitaxel-coated devices and control arms (2.3% versus 2.3% crude risk of death; risk ratio, 1.08; 95% CI, 0.72-1.61). All-cause death at 2 years (12 RCTs with 2316 cases) was significantly increased in the case of paclitaxel versus control (7.2% versus 3.8% crude risk of death; risk ratio, 1.68; 95% CI, 1.15- 2.47; -number-needed-to-harm, 29 patients [95% CI, 19-59]). All-cause death up to 5 years (3 RCTs with 863 cases) increased further in the case of paclitaxel (14.7% versus 8.1% crude risk of death; risk ratio, 1.93; 95% CI, 1.27-2.93; -number-needed-toharm, 14 patients [95% CI, 9-32]). Meta-regression showed a significant relationship between exposure to paclitaxel (dose-time product) and absolute risk of death (0.4±0.1% excess risk of death per paclitaxel mg-year; P<0.001). Trial sequential analysis excluded false-positive findings with 99% certainty (2-sided a, 1.0%). Conclusions-There is increased risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the lower limbs. Further investigations are urgently warranted. Clinical Trial Registration-URL: www.crd.york.ac.uk/PROSPERO. Unique identifier: CRD42018099447. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: A systematic review and meta-analysis of randomized controlled trials ###Abstract: Background-Several randomized controlled trials (RCTs) have already shown that paclitaxel-coated balloons and stents significantly reduce the rates of vessel restenosis and target lesion revascularization after lower extremity interventions. Methods and Results-A systematic review and meta-analysis of RCTs investigating paclitaxel-coated devices in the femoral and/ or popliteal arteries was performed. The primary safety measure was all-cause patient death. Risk ratios and risk differences were pooled with a random effects model. In all, 28 RCTs with 4663 patients (89% intermittent claudication) were analyzed. All-cause patient death at 1 year (28 RCTs with 4432 cases) was similar between paclitaxel-coated devices and control arms (2.3% versus 2.3% crude risk of death; risk ratio, 1.08; 95% CI, 0.72-1.61). All-cause death at 2 years (12 RCTs with 2316 cases) was significantly increased in the case of paclitaxel versus control (7.2% versus 3.8% crude risk of death; risk ratio, 1.68; 95% CI, 1.15- 2.47; -number-needed-to-harm, 29 patients [95% CI, 19-59]). All-cause death up to 5 years (3 RCTs with 863 cases) increased further in the case of paclitaxel (14.7% versus 8.1% crude risk of death; risk ratio, 1.93; 95% CI, 1.27-2.93; -number-needed-toharm, 14 patients [95% CI, 9-32]). Meta-regression showed a significant relationship between exposure to paclitaxel (dose-time product) and absolute risk of death (0.4±0.1% excess risk of death per paclitaxel mg-year; P<0.001). Trial sequential analysis excluded false-positive findings with 99% certainty (2-sided a, 1.0%). Conclusions-There is increased risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the lower limbs. Further investigations are urgently warranted. Clinical Trial Registration-URL: www.crd.york.ac.uk/PROSPERO. Unique identifier: CRD42018099447. [/INST] Include </s>
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Kim 2020
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Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: A prospective randomized controlled trial
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Objective: To report the mid-term results of a single-center randomized controlled trial comparing drug-coated balloon angioplasty (DBA) and plain balloon angioplasty (PBA) for the treatment of dysfunctional radiocephalic arteriovenous fistulas (RCAVFs). Materials and Methods: In this prospective study, 39 patients (mean age, 62.2 years; 21 males, 18 females) with RCAVFs failing due to juxta-anastomotic stenosis were randomly assigned to undergo either both DBA and PBA (n = 20, DBA group) or PBA alone (n = 19, PBA group) between June 2016 and June 2018. Primary endpoints were technical and clinical success and target lesion primary patency (TLPP); secondary outcomes were target lesion secondary patency (TLSP) and complication rates. Statistical analysis was performed using the Kaplan-Meier product limit estimator. Results: Demographic data and baseline clinical characteristics were comparable between the groups. Technical and clinical success rates were 100% in both groups. There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months; p = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months; p = 0.585). No procedural or post-procedural complications were identified. Conclusion: Paclitaxel-coated balloon use did not significantly improve TLPP or TLSP in the treatment of juxta-anastomotic stenosis of dysfunctional RCAVFs.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: A prospective randomized controlled trial ###Abstract: Objective: To report the mid-term results of a single-center randomized controlled trial comparing drug-coated balloon angioplasty (DBA) and plain balloon angioplasty (PBA) for the treatment of dysfunctional radiocephalic arteriovenous fistulas (RCAVFs). Materials and Methods: In this prospective study, 39 patients (mean age, 62.2 years; 21 males, 18 females) with RCAVFs failing due to juxta-anastomotic stenosis were randomly assigned to undergo either both DBA and PBA (n = 20, DBA group) or PBA alone (n = 19, PBA group) between June 2016 and June 2018. Primary endpoints were technical and clinical success and target lesion primary patency (TLPP); secondary outcomes were target lesion secondary patency (TLSP) and complication rates. Statistical analysis was performed using the Kaplan-Meier product limit estimator. Results: Demographic data and baseline clinical characteristics were comparable between the groups. Technical and clinical success rates were 100% in both groups. There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months; p = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months; p = 0.585). No procedural or post-procedural complications were identified. Conclusion: Paclitaxel-coated balloon use did not significantly improve TLPP or TLSP in the treatment of juxta-anastomotic stenosis of dysfunctional RCAVFs. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: A prospective randomized controlled trial ###Abstract: Objective: To report the mid-term results of a single-center randomized controlled trial comparing drug-coated balloon angioplasty (DBA) and plain balloon angioplasty (PBA) for the treatment of dysfunctional radiocephalic arteriovenous fistulas (RCAVFs). Materials and Methods: In this prospective study, 39 patients (mean age, 62.2 years; 21 males, 18 females) with RCAVFs failing due to juxta-anastomotic stenosis were randomly assigned to undergo either both DBA and PBA (n = 20, DBA group) or PBA alone (n = 19, PBA group) between June 2016 and June 2018. Primary endpoints were technical and clinical success and target lesion primary patency (TLPP); secondary outcomes were target lesion secondary patency (TLSP) and complication rates. Statistical analysis was performed using the Kaplan-Meier product limit estimator. Results: Demographic data and baseline clinical characteristics were comparable between the groups. Technical and clinical success rates were 100% in both groups. There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months; p = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months; p = 0.585). No procedural or post-procedural complications were identified. Conclusion: Paclitaxel-coated balloon use did not significantly improve TLPP or TLSP in the treatment of juxta-anastomotic stenosis of dysfunctional RCAVFs. [/INST] Include </s>
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Kitrou 2015a
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Paclitaxel-coated versus plain balloon angioplasty for dysfunctional arteriovenous fistulae: One-year results of a prospective randomized controlled trial
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Purpose: To report 1-year results of a single-center randomized controlled trial comparing paclitaxel-coated balloon (PCB) versus high-pressure plain balloon angioplasty for the treatment of failing arteriovenous fistulae (AVFs). Materials and Methods: Forty patients (26 men; mean age, 61 y ± 14.63) were randomized at 1:1 to undergo PCB (n = 20) or high-pressure balloon (HPB; n = 20) angioplasty of dysfunctional AVFs. There were no significant differences in baseline demographics between groups. Enrollment required a clinical diagnosis of a dysfunctional AVF attributed to a single stenotic lesion verified with digital subtraction angiography. Primary endpoints included device success, anatomic success, clinical success, and target lesion revascularization (TLR)-free survival. Secondary endpoints included dialysis circuit primary patency and procedure-related complication rates. Results: Device success rates were 100% in the HPB group and 35% in the PCB group (P < 0001): further dilation with an HPB was needed to achieve anatomic success in 13 of 20 cases in the PCB group (65%). Anatomic and clinical success rates were 100% in both groups. TLR-free survival (PCB, 308 d; HPB, 161 d; hazard ratio [HR], 0.478; 95% confidence interval [CI], 0.236-0.966; P = .03) and access circuit primary patency (PCB, 270 d; HPB, 161 d; HR, 0.479; 95% CI, 0.237-0.968; P = .04) were significantly in favor of PCB angioplasty. No minor or major procedure-related complications occurred. Conclusions: In this single-center study, the use of PCBs resulted in superior TLR-free survival and dialysis access circuit primary patency of dysfunctional AVFs. However, additional HPB postdilation was required in the majority of cases.& SIR, 2015.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel-coated versus plain balloon angioplasty for dysfunctional arteriovenous fistulae: One-year results of a prospective randomized controlled trial ###Abstract: Purpose: To report 1-year results of a single-center randomized controlled trial comparing paclitaxel-coated balloon (PCB) versus high-pressure plain balloon angioplasty for the treatment of failing arteriovenous fistulae (AVFs). Materials and Methods: Forty patients (26 men; mean age, 61 y ± 14.63) were randomized at 1:1 to undergo PCB (n = 20) or high-pressure balloon (HPB; n = 20) angioplasty of dysfunctional AVFs. There were no significant differences in baseline demographics between groups. Enrollment required a clinical diagnosis of a dysfunctional AVF attributed to a single stenotic lesion verified with digital subtraction angiography. Primary endpoints included device success, anatomic success, clinical success, and target lesion revascularization (TLR)-free survival. Secondary endpoints included dialysis circuit primary patency and procedure-related complication rates. Results: Device success rates were 100% in the HPB group and 35% in the PCB group (P < 0001): further dilation with an HPB was needed to achieve anatomic success in 13 of 20 cases in the PCB group (65%). Anatomic and clinical success rates were 100% in both groups. TLR-free survival (PCB, 308 d; HPB, 161 d; hazard ratio [HR], 0.478; 95% confidence interval [CI], 0.236-0.966; P = .03) and access circuit primary patency (PCB, 270 d; HPB, 161 d; HR, 0.479; 95% CI, 0.237-0.968; P = .04) were significantly in favor of PCB angioplasty. No minor or major procedure-related complications occurred. Conclusions: In this single-center study, the use of PCBs resulted in superior TLR-free survival and dialysis access circuit primary patency of dysfunctional AVFs. However, additional HPB postdilation was required in the majority of cases.& SIR, 2015. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel-coated versus plain balloon angioplasty for dysfunctional arteriovenous fistulae: One-year results of a prospective randomized controlled trial ###Abstract: Purpose: To report 1-year results of a single-center randomized controlled trial comparing paclitaxel-coated balloon (PCB) versus high-pressure plain balloon angioplasty for the treatment of failing arteriovenous fistulae (AVFs). Materials and Methods: Forty patients (26 men; mean age, 61 y ± 14.63) were randomized at 1:1 to undergo PCB (n = 20) or high-pressure balloon (HPB; n = 20) angioplasty of dysfunctional AVFs. There were no significant differences in baseline demographics between groups. Enrollment required a clinical diagnosis of a dysfunctional AVF attributed to a single stenotic lesion verified with digital subtraction angiography. Primary endpoints included device success, anatomic success, clinical success, and target lesion revascularization (TLR)-free survival. Secondary endpoints included dialysis circuit primary patency and procedure-related complication rates. Results: Device success rates were 100% in the HPB group and 35% in the PCB group (P < 0001): further dilation with an HPB was needed to achieve anatomic success in 13 of 20 cases in the PCB group (65%). Anatomic and clinical success rates were 100% in both groups. TLR-free survival (PCB, 308 d; HPB, 161 d; hazard ratio [HR], 0.478; 95% confidence interval [CI], 0.236-0.966; P = .03) and access circuit primary patency (PCB, 270 d; HPB, 161 d; HR, 0.479; 95% CI, 0.237-0.968; P = .04) were significantly in favor of PCB angioplasty. No minor or major procedure-related complications occurred. Conclusions: In this single-center study, the use of PCBs resulted in superior TLR-free survival and dialysis access circuit primary patency of dysfunctional AVFs. However, additional HPB postdilation was required in the majority of cases.& SIR, 2015. [/INST] Include </s>
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Kitrou 2015b
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Paclitaxel-Coated versus Plain Balloon Angioplasty for Dysfunctional Arteriovenous Fistulae: One-Year Results of a Prospective Randomized Controlled Trial
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Purpose To report 1-year results of a single-center randomized controlled trial comparing paclitaxel-coated balloon (PCB) versus high-pressure plain balloon angioplasty for the treatment of failing arteriovenous fistulae (AVFs). Materials and Methods Forty patients (26 men; mean age, 61 y ± 14.63) were randomized at 1:1 to undergo PCB (n = 20) or high-pressure balloon (HPB; n = 20) angioplasty of dysfunctional AVFs. There were no significant differences in baseline demographics between groups. Enrollment required a clinical diagnosis of a dysfunctional AVF attributed to a single stenotic lesion verified with digital subtraction angiography. Primary endpoints included device success, anatomic success, clinical success, and target lesion revascularization (TLR)–free survival. Secondary endpoints included dialysis circuit primary patency and procedure-related complication rates. Results Device success rates were 100% in the HPB group and 35% in the PCB group (P < 0001): further dilation with an HPB was needed to achieve anatomic success in 13 of 20 cases in the PCB group (65%). Anatomic and clinical success rates were 100% in both groups. TLR-free survival (PCB, 308 d; HPB, 161 d; hazard ratio [HR], 0.478; 95% confidence interval [CI], 0.236–0.966; P = .03) and access circuit primary patency (PCB, 270 d; HPB, 161 d; HR, 0.479; 95% CI, 0.237–0.968; P = .04) were significantly in favor of PCB angioplasty. No minor or major procedure-related complications occurred. Conclusions In this single-center study, the use of PCBs resulted in superior TLR-free survival and dialysis access circuit primary patency of dysfunctional AVFs. However, additional HPB postdilation was required in the majority of cases.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel-Coated versus Plain Balloon Angioplasty for Dysfunctional Arteriovenous Fistulae: One-Year Results of a Prospective Randomized Controlled Trial ###Abstract: Purpose To report 1-year results of a single-center randomized controlled trial comparing paclitaxel-coated balloon (PCB) versus high-pressure plain balloon angioplasty for the treatment of failing arteriovenous fistulae (AVFs). Materials and Methods Forty patients (26 men; mean age, 61 y ± 14.63) were randomized at 1:1 to undergo PCB (n = 20) or high-pressure balloon (HPB; n = 20) angioplasty of dysfunctional AVFs. There were no significant differences in baseline demographics between groups. Enrollment required a clinical diagnosis of a dysfunctional AVF attributed to a single stenotic lesion verified with digital subtraction angiography. Primary endpoints included device success, anatomic success, clinical success, and target lesion revascularization (TLR)–free survival. Secondary endpoints included dialysis circuit primary patency and procedure-related complication rates. Results Device success rates were 100% in the HPB group and 35% in the PCB group (P < 0001): further dilation with an HPB was needed to achieve anatomic success in 13 of 20 cases in the PCB group (65%). Anatomic and clinical success rates were 100% in both groups. TLR-free survival (PCB, 308 d; HPB, 161 d; hazard ratio [HR], 0.478; 95% confidence interval [CI], 0.236–0.966; P = .03) and access circuit primary patency (PCB, 270 d; HPB, 161 d; HR, 0.479; 95% CI, 0.237–0.968; P = .04) were significantly in favor of PCB angioplasty. No minor or major procedure-related complications occurred. Conclusions In this single-center study, the use of PCBs resulted in superior TLR-free survival and dialysis access circuit primary patency of dysfunctional AVFs. However, additional HPB postdilation was required in the majority of cases. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel-Coated versus Plain Balloon Angioplasty for Dysfunctional Arteriovenous Fistulae: One-Year Results of a Prospective Randomized Controlled Trial ###Abstract: Purpose To report 1-year results of a single-center randomized controlled trial comparing paclitaxel-coated balloon (PCB) versus high-pressure plain balloon angioplasty for the treatment of failing arteriovenous fistulae (AVFs). Materials and Methods Forty patients (26 men; mean age, 61 y ± 14.63) were randomized at 1:1 to undergo PCB (n = 20) or high-pressure balloon (HPB; n = 20) angioplasty of dysfunctional AVFs. There were no significant differences in baseline demographics between groups. Enrollment required a clinical diagnosis of a dysfunctional AVF attributed to a single stenotic lesion verified with digital subtraction angiography. Primary endpoints included device success, anatomic success, clinical success, and target lesion revascularization (TLR)–free survival. Secondary endpoints included dialysis circuit primary patency and procedure-related complication rates. Results Device success rates were 100% in the HPB group and 35% in the PCB group (P < 0001): further dilation with an HPB was needed to achieve anatomic success in 13 of 20 cases in the PCB group (65%). Anatomic and clinical success rates were 100% in both groups. TLR-free survival (PCB, 308 d; HPB, 161 d; hazard ratio [HR], 0.478; 95% confidence interval [CI], 0.236–0.966; P = .03) and access circuit primary patency (PCB, 270 d; HPB, 161 d; HR, 0.479; 95% CI, 0.237–0.968; P = .04) were significantly in favor of PCB angioplasty. No minor or major procedure-related complications occurred. Conclusions In this single-center study, the use of PCBs resulted in superior TLR-free survival and dialysis access circuit primary patency of dysfunctional AVFs. However, additional HPB postdilation was required in the majority of cases. [/INST] Include </s>
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Kobayashi 2020
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Sustained drug retention after paclitaxel-coated balloon angioplasty for superficial femoral artery disease: Follow-up intravascular imaging
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A 63 year-old woman with claudication underwent endovascular therapy for diffuse stenosis of the right superficial femoral artery in our hospital. We performed paclitaxel-coated balloon angioplasty using the IN.PACT™ Admiral™ and achieved acceptable results. After 42 days, we performed follow-up optical frequency domain imaging for the right superficial femoral artery lesion treated with paclitaxel-coated balloon and observed several high-intensity regions with attenuation on the lumen surface. Sustained drug availability is a notable characteristic of paclitaxel-coated balloon. To the best of our knowledge, this is the first report on the visualization of sustained drug retention on the lumen surface using follow-up optical frequency domain imaging after paclitaxel-coated balloon angioplasty in a human patient with superficial femoral artery disease.
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Include
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DI3 - Case Report
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Sustained drug retention after paclitaxel-coated balloon angioplasty for superficial femoral artery disease: Follow-up intravascular imaging ###Abstract: A 63 year-old woman with claudication underwent endovascular therapy for diffuse stenosis of the right superficial femoral artery in our hospital. We performed paclitaxel-coated balloon angioplasty using the IN.PACT™ Admiral™ and achieved acceptable results. After 42 days, we performed follow-up optical frequency domain imaging for the right superficial femoral artery lesion treated with paclitaxel-coated balloon and observed several high-intensity regions with attenuation on the lumen surface. Sustained drug availability is a notable characteristic of paclitaxel-coated balloon. To the best of our knowledge, this is the first report on the visualization of sustained drug retention on the lumen surface using follow-up optical frequency domain imaging after paclitaxel-coated balloon angioplasty in a human patient with superficial femoral artery disease. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Sustained drug retention after paclitaxel-coated balloon angioplasty for superficial femoral artery disease: Follow-up intravascular imaging ###Abstract: A 63 year-old woman with claudication underwent endovascular therapy for diffuse stenosis of the right superficial femoral artery in our hospital. We performed paclitaxel-coated balloon angioplasty using the IN.PACT™ Admiral™ and achieved acceptable results. After 42 days, we performed follow-up optical frequency domain imaging for the right superficial femoral artery lesion treated with paclitaxel-coated balloon and observed several high-intensity regions with attenuation on the lumen surface. Sustained drug availability is a notable characteristic of paclitaxel-coated balloon. To the best of our knowledge, this is the first report on the visualization of sustained drug retention on the lumen surface using follow-up optical frequency domain imaging after paclitaxel-coated balloon angioplasty in a human patient with superficial femoral artery disease. [/INST] Include </s>
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Kocaaslan 2020
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A retrospective comparison analysis of results of drug-coated balloon versus plain balloon angioplasty in treatment of juxta-anastomotic de novo stenosis of radiocephalic arteriovenous fistulas
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Background: Juxta-anastomotic stenosis is a common issue of arteriovenous fistulas. We aimed to evaluate the results of percutaneous transluminal angioplasty with drug-coated balloon versus plain balloon for the treatment of juxta-anastomotic stenoses of mature but failing distal radiocephalic arteriovenous fistulas. Methods: A total of 80 patients with a juxta-anastomotic stenosis of distal radiocephalic arteriovenous fistula in our clinic between January 2016 and September 2017 were retrospectively analyzed. Patients were divided into two groups according to the type of treatment as drug-coated balloon – percutaneous transluminal angioplasty (n = 44) and plain balloon – percutaneous transluminal angioplasty (n = 43). Intra- and post-procedural data were recorded. Target lesion primary patency rate was evaluated at 6 and 12 months. Of all patients, 48 were females and 39 were males with a mean age of 56.3 ± 10.4 (range, 24–75) years. Both groups had mature fistulas, and the mean age of fistula was 11.3 ± 9.1 months in the drug-coated balloon – percutaneous transluminal angioplasty group and 10.3 ± 8.8 months in the plain balloon – percutaneous transluminal angioplasty group (p = 0.24). Results: There was no significant difference in the target lesion stenosis rate and the median lesion length between the groups. Technical and clinical success were achieved in both groups. Target lesion primary patency was similar at 6 months between the two groups (93.1% vs 81.3%, respectively; p = 0.14) but significantly higher for the drug-coated balloon – percutaneous transluminal angioplasty group at 12 months (81.8% vs 51.1%, respectively; p = 0.01). Conclusion: Our study results suggest that the use of drug-coated balloon combined with percutaneous transluminal angioplasty is an effective treatment for juxta-anastomotic stenoses of mature but failing distal radiocephalic arteriovenous fistulas with significantly improved target lesion primary patency rates and reduced need for juxta-anastomotic reinterventions.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: A retrospective comparison analysis of results of drug-coated balloon versus plain balloon angioplasty in treatment of juxta-anastomotic de novo stenosis of radiocephalic arteriovenous fistulas ###Abstract: Background: Juxta-anastomotic stenosis is a common issue of arteriovenous fistulas. We aimed to evaluate the results of percutaneous transluminal angioplasty with drug-coated balloon versus plain balloon for the treatment of juxta-anastomotic stenoses of mature but failing distal radiocephalic arteriovenous fistulas. Methods: A total of 80 patients with a juxta-anastomotic stenosis of distal radiocephalic arteriovenous fistula in our clinic between January 2016 and September 2017 were retrospectively analyzed. Patients were divided into two groups according to the type of treatment as drug-coated balloon – percutaneous transluminal angioplasty (n = 44) and plain balloon – percutaneous transluminal angioplasty (n = 43). Intra- and post-procedural data were recorded. Target lesion primary patency rate was evaluated at 6 and 12 months. Of all patients, 48 were females and 39 were males with a mean age of 56.3 ± 10.4 (range, 24–75) years. Both groups had mature fistulas, and the mean age of fistula was 11.3 ± 9.1 months in the drug-coated balloon – percutaneous transluminal angioplasty group and 10.3 ± 8.8 months in the plain balloon – percutaneous transluminal angioplasty group (p = 0.24). Results: There was no significant difference in the target lesion stenosis rate and the median lesion length between the groups. Technical and clinical success were achieved in both groups. Target lesion primary patency was similar at 6 months between the two groups (93.1% vs 81.3%, respectively; p = 0.14) but significantly higher for the drug-coated balloon – percutaneous transluminal angioplasty group at 12 months (81.8% vs 51.1%, respectively; p = 0.01). Conclusion: Our study results suggest that the use of drug-coated balloon combined with percutaneous transluminal angioplasty is an effective treatment for juxta-anastomotic stenoses of mature but failing distal radiocephalic arteriovenous fistulas with significantly improved target lesion primary patency rates and reduced need for juxta-anastomotic reinterventions. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: A retrospective comparison analysis of results of drug-coated balloon versus plain balloon angioplasty in treatment of juxta-anastomotic de novo stenosis of radiocephalic arteriovenous fistulas ###Abstract: Background: Juxta-anastomotic stenosis is a common issue of arteriovenous fistulas. We aimed to evaluate the results of percutaneous transluminal angioplasty with drug-coated balloon versus plain balloon for the treatment of juxta-anastomotic stenoses of mature but failing distal radiocephalic arteriovenous fistulas. Methods: A total of 80 patients with a juxta-anastomotic stenosis of distal radiocephalic arteriovenous fistula in our clinic between January 2016 and September 2017 were retrospectively analyzed. Patients were divided into two groups according to the type of treatment as drug-coated balloon – percutaneous transluminal angioplasty (n = 44) and plain balloon – percutaneous transluminal angioplasty (n = 43). Intra- and post-procedural data were recorded. Target lesion primary patency rate was evaluated at 6 and 12 months. Of all patients, 48 were females and 39 were males with a mean age of 56.3 ± 10.4 (range, 24–75) years. Both groups had mature fistulas, and the mean age of fistula was 11.3 ± 9.1 months in the drug-coated balloon – percutaneous transluminal angioplasty group and 10.3 ± 8.8 months in the plain balloon – percutaneous transluminal angioplasty group (p = 0.24). Results: There was no significant difference in the target lesion stenosis rate and the median lesion length between the groups. Technical and clinical success were achieved in both groups. Target lesion primary patency was similar at 6 months between the two groups (93.1% vs 81.3%, respectively; p = 0.14) but significantly higher for the drug-coated balloon – percutaneous transluminal angioplasty group at 12 months (81.8% vs 51.1%, respectively; p = 0.01). Conclusion: Our study results suggest that the use of drug-coated balloon combined with percutaneous transluminal angioplasty is an effective treatment for juxta-anastomotic stenoses of mature but failing distal radiocephalic arteriovenous fistulas with significantly improved target lesion primary patency rates and reduced need for juxta-anastomotic reinterventions. [/INST] Include </s>
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Kohi 2020
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Sex-Related Differences in the Long-Term Outcomes of Patients with Femoropopliteal Arterial Disease Treated with the IN.PACT Drug-Coated Balloon in the IN.PACT SFA Randomized Controlled Trial: A Post Hoc Analysis
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Purpose: To evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA). Materials and Methods: A post hoc analysis of the IN.PACT SFA trial was performed. Participants with Rutherford Clinical Classification 2–4 PAD and femoropopliteal artery lesions up to 18 cm long were randomly assigned to treatment with DCB (n = 220) or PTA (n = 111). Effectiveness outcomes were evaluated, including 36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR]). Results: In the DCB group, women were significantly older (69.4 y ± 9.9) than men (66.4 y ± 9.1; P = .025). Mean reference vessel diameter (RVD) was significantly smaller in women (4.4 mm ± 0.68) compared with men (4.8 mm ± 0.89, P < .001). Primary patency was 65.4% in women and 71.8% in men (P = .302). Freedom from CD-TLR was 81.1% in women and 86.4% in men (P = .285). Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P = .063). Mean RVD was significantly smaller in women (4.2 mm ± 0.77) compared with men (4.9 mm ± 0.77, P < .001). Primary patency was 42.3% in women and 46.7% in men (P = .551). Freedom from CD-TLR was 59.4% in women and 75.5% in men (P = .109). No significant differences were noted in safety and mortality outcomes. Conclusions: In both groups, women were older and had smaller vessels. Particularly in the PTA group, women had worse clinical outcomes, though not reaching statistical significance. Further evaluation is necessary to understand the disparate nature of disease progression and outcomes following endovascular treatment in women compared with men.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Sex-Related Differences in the Long-Term Outcomes of Patients with Femoropopliteal Arterial Disease Treated with the IN.PACT Drug-Coated Balloon in the IN.PACT SFA Randomized Controlled Trial: A Post Hoc Analysis ###Abstract: Purpose: To evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA). Materials and Methods: A post hoc analysis of the IN.PACT SFA trial was performed. Participants with Rutherford Clinical Classification 2–4 PAD and femoropopliteal artery lesions up to 18 cm long were randomly assigned to treatment with DCB (n = 220) or PTA (n = 111). Effectiveness outcomes were evaluated, including 36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR]). Results: In the DCB group, women were significantly older (69.4 y ± 9.9) than men (66.4 y ± 9.1; P = .025). Mean reference vessel diameter (RVD) was significantly smaller in women (4.4 mm ± 0.68) compared with men (4.8 mm ± 0.89, P < .001). Primary patency was 65.4% in women and 71.8% in men (P = .302). Freedom from CD-TLR was 81.1% in women and 86.4% in men (P = .285). Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P = .063). Mean RVD was significantly smaller in women (4.2 mm ± 0.77) compared with men (4.9 mm ± 0.77, P < .001). Primary patency was 42.3% in women and 46.7% in men (P = .551). Freedom from CD-TLR was 59.4% in women and 75.5% in men (P = .109). No significant differences were noted in safety and mortality outcomes. Conclusions: In both groups, women were older and had smaller vessels. Particularly in the PTA group, women had worse clinical outcomes, though not reaching statistical significance. Further evaluation is necessary to understand the disparate nature of disease progression and outcomes following endovascular treatment in women compared with men. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Sex-Related Differences in the Long-Term Outcomes of Patients with Femoropopliteal Arterial Disease Treated with the IN.PACT Drug-Coated Balloon in the IN.PACT SFA Randomized Controlled Trial: A Post Hoc Analysis ###Abstract: Purpose: To evaluate sex-related disparities in long-term outcomes of patients with peripheral artery disease (PAD) treated with IN.PACT drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA). Materials and Methods: A post hoc analysis of the IN.PACT SFA trial was performed. Participants with Rutherford Clinical Classification 2–4 PAD and femoropopliteal artery lesions up to 18 cm long were randomly assigned to treatment with DCB (n = 220) or PTA (n = 111). Effectiveness outcomes were evaluated, including 36-month primary patency (freedom from binary restenosis and freedom from clinically driven [CD] target lesion revascularization [TLR]). Results: In the DCB group, women were significantly older (69.4 y ± 9.9) than men (66.4 y ± 9.1; P = .025). Mean reference vessel diameter (RVD) was significantly smaller in women (4.4 mm ± 0.68) compared with men (4.8 mm ± 0.89, P < .001). Primary patency was 65.4% in women and 71.8% in men (P = .302). Freedom from CD-TLR was 81.1% in women and 86.4% in men (P = .285). Women treated with PTA were older (70.4 y ± 8.3) than men (66.9 y ± 9.5; P = .063). Mean RVD was significantly smaller in women (4.2 mm ± 0.77) compared with men (4.9 mm ± 0.77, P < .001). Primary patency was 42.3% in women and 46.7% in men (P = .551). Freedom from CD-TLR was 59.4% in women and 75.5% in men (P = .109). No significant differences were noted in safety and mortality outcomes. Conclusions: In both groups, women were older and had smaller vessels. Particularly in the PTA group, women had worse clinical outcomes, though not reaching statistical significance. Further evaluation is necessary to understand the disparate nature of disease progression and outcomes following endovascular treatment in women compared with men. [/INST] Include </s>
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Kokkinidis 2018a
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Laser Atherectomy Combined With Drug-Coated Balloon Angioplasty Is Associated With Improved 1-Year Outcomes for Treatment of Femoropopliteal In-Stent Restenosis
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Purpose: To examine whether laser atherectomy combined with drug-coated balloons (laser + DCB) can improve the outcomes of femoropopliteal (FP) in-stent restenosis (ISR). Methods: A dual-center retrospective study was conducted of 112 consecutive patients (mean age 70.3±10.6 years; 86 men) with Tosaka class II (n=29; diffuse stenosis) or III (n=83; occlusion) FP-ISR lesions. Sixty-two patients (mean age 68.5±10 years; 51 men) underwent laser + DCB while the other 50 patients (mean age 72.5±10.8 years; 35 men) had laser atherectomy plus balloon angioplasty (laser + BA). Critical limb ischemia was the indication in 33% of the interventions. The average lesion length was 247 mm. A Cox regression hazard model was developed to examine the association between laser + DCB vs laser + BA; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). One-year target lesion revascularization (TLR) and reocclusion were estimated using the Kaplan-Meier method. Results: Overall procedure success was 98% and was similar between groups. Bailout stenting was less often required in the laser + DCB group (31.7% vs 58%, p=0.006). The combination of laser + DCB was associated with improved 12-month estimates for freedom from TLR (72.5% vs 50.5%, p=0.043) and freedom from reocclusion (86.7% vs 56.9%, p=0.003). Among patients with Tosaka III FP-ISR, combination therapy with laser + DCB was also associated with increased freedom from reocclusion (87.1% vs 57.1%, p=0. 028). On multivariable analysis, treatment with laser + DCB was associated with a significantly reduced risk of reocclusion (HR 0.08, 95% CI 0.17 to 0.38; p=0.002). Conclusion: When used for treatment of complex FP-ISR lesions, DCB angioplasty combined with laser atherectomy is associated with significantly reduced 1-year TLR and reocclusion rates.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Laser Atherectomy Combined With Drug-Coated Balloon Angioplasty Is Associated With Improved 1-Year Outcomes for Treatment of Femoropopliteal In-Stent Restenosis ###Abstract: Purpose: To examine whether laser atherectomy combined with drug-coated balloons (laser + DCB) can improve the outcomes of femoropopliteal (FP) in-stent restenosis (ISR). Methods: A dual-center retrospective study was conducted of 112 consecutive patients (mean age 70.3±10.6 years; 86 men) with Tosaka class II (n=29; diffuse stenosis) or III (n=83; occlusion) FP-ISR lesions. Sixty-two patients (mean age 68.5±10 years; 51 men) underwent laser + DCB while the other 50 patients (mean age 72.5±10.8 years; 35 men) had laser atherectomy plus balloon angioplasty (laser + BA). Critical limb ischemia was the indication in 33% of the interventions. The average lesion length was 247 mm. A Cox regression hazard model was developed to examine the association between laser + DCB vs laser + BA; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). One-year target lesion revascularization (TLR) and reocclusion were estimated using the Kaplan-Meier method. Results: Overall procedure success was 98% and was similar between groups. Bailout stenting was less often required in the laser + DCB group (31.7% vs 58%, p=0.006). The combination of laser + DCB was associated with improved 12-month estimates for freedom from TLR (72.5% vs 50.5%, p=0.043) and freedom from reocclusion (86.7% vs 56.9%, p=0.003). Among patients with Tosaka III FP-ISR, combination therapy with laser + DCB was also associated with increased freedom from reocclusion (87.1% vs 57.1%, p=0. 028). On multivariable analysis, treatment with laser + DCB was associated with a significantly reduced risk of reocclusion (HR 0.08, 95% CI 0.17 to 0.38; p=0.002). Conclusion: When used for treatment of complex FP-ISR lesions, DCB angioplasty combined with laser atherectomy is associated with significantly reduced 1-year TLR and reocclusion rates. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Laser Atherectomy Combined With Drug-Coated Balloon Angioplasty Is Associated With Improved 1-Year Outcomes for Treatment of Femoropopliteal In-Stent Restenosis ###Abstract: Purpose: To examine whether laser atherectomy combined with drug-coated balloons (laser + DCB) can improve the outcomes of femoropopliteal (FP) in-stent restenosis (ISR). Methods: A dual-center retrospective study was conducted of 112 consecutive patients (mean age 70.3±10.6 years; 86 men) with Tosaka class II (n=29; diffuse stenosis) or III (n=83; occlusion) FP-ISR lesions. Sixty-two patients (mean age 68.5±10 years; 51 men) underwent laser + DCB while the other 50 patients (mean age 72.5±10.8 years; 35 men) had laser atherectomy plus balloon angioplasty (laser + BA). Critical limb ischemia was the indication in 33% of the interventions. The average lesion length was 247 mm. A Cox regression hazard model was developed to examine the association between laser + DCB vs laser + BA; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). One-year target lesion revascularization (TLR) and reocclusion were estimated using the Kaplan-Meier method. Results: Overall procedure success was 98% and was similar between groups. Bailout stenting was less often required in the laser + DCB group (31.7% vs 58%, p=0.006). The combination of laser + DCB was associated with improved 12-month estimates for freedom from TLR (72.5% vs 50.5%, p=0.043) and freedom from reocclusion (86.7% vs 56.9%, p=0.003). Among patients with Tosaka III FP-ISR, combination therapy with laser + DCB was also associated with increased freedom from reocclusion (87.1% vs 57.1%, p=0. 028). On multivariable analysis, treatment with laser + DCB was associated with a significantly reduced risk of reocclusion (HR 0.08, 95% CI 0.17 to 0.38; p=0.002). Conclusion: When used for treatment of complex FP-ISR lesions, DCB angioplasty combined with laser atherectomy is associated with significantly reduced 1-year TLR and reocclusion rates. [/INST] Include </s>
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Kokkinidis 2020
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Laser atherectomy and drug-coated balloons for the treatment of femoropopliteal in-stent restenosis: 2-Year outcomes
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Background: Femoropopliteal (FP) artery is one of the most anatomically challenging areas for sustained stent patency. The incidence of FP in-stent restenosis (ISR) is estimated at 50% at 24 months. Prior studies have shown that lesion debulking with laser atherectomy (LA) combined with drug coated balloon (DCB) have superior outcomes compared to LA + balloon angioplasty (BA) ISR, but there have not been studies evaluating 2-year outcomes. Methods: This was a dual-center retrospective cohort study that compared patients with FP-ISR treated with LA + DCB versus LA + BA. Cox regression analysis was used to examine 2-year outcomes of target lesion revascularization (TLR) and the composite outcome of TLR or restenosis. Multivariable analysis was performed for clinical and statistically significant (in the univariate analysis) variables. Results: One hundred and seventeen consecutive patients with Tosaka II (n = 32) and III (n = 85) ISR were analyzed. Sixty-six patients were treated with LA + DCB and 51 with LA + BA. The LA + DCB group had more lesions with moderate to severe calcification (58% vs. 13%; p <.0001). The LA + DCB group was more likely to be treated with the use of embolic protection devices (64% vs. 23%, p <.001) and cutting balloons (61% vs. 6%, p <.001). Bail-out stenting rates were lower in the LA + DCB group (32% vs. 57%, p =.008). LA + DCB was superior (HR: 0.57; 95% CI: 0.34–0.9, p =.027) for the composite outcome of 2-year TLR or restenosis. The 12-month KM estimates for freedom from TLR or restenosis were 66% in the LA + DCB group versus 46% in the LA + BA group. The 24-month KM estimates were 45% in the LA + DCB group versus 24% in the LA + BA group. Conclusions: The combination of DCB + LA was associated with decreased rates of bail-out stenting and improved 2-year TLR or restenosis rates. Randomized clinical trials examining the DCB + LA combination for FP-ISR are needed.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Laser atherectomy and drug-coated balloons for the treatment of femoropopliteal in-stent restenosis: 2-Year outcomes ###Abstract: Background: Femoropopliteal (FP) artery is one of the most anatomically challenging areas for sustained stent patency. The incidence of FP in-stent restenosis (ISR) is estimated at 50% at 24 months. Prior studies have shown that lesion debulking with laser atherectomy (LA) combined with drug coated balloon (DCB) have superior outcomes compared to LA + balloon angioplasty (BA) ISR, but there have not been studies evaluating 2-year outcomes. Methods: This was a dual-center retrospective cohort study that compared patients with FP-ISR treated with LA + DCB versus LA + BA. Cox regression analysis was used to examine 2-year outcomes of target lesion revascularization (TLR) and the composite outcome of TLR or restenosis. Multivariable analysis was performed for clinical and statistically significant (in the univariate analysis) variables. Results: One hundred and seventeen consecutive patients with Tosaka II (n = 32) and III (n = 85) ISR were analyzed. Sixty-six patients were treated with LA + DCB and 51 with LA + BA. The LA + DCB group had more lesions with moderate to severe calcification (58% vs. 13%; p <.0001). The LA + DCB group was more likely to be treated with the use of embolic protection devices (64% vs. 23%, p <.001) and cutting balloons (61% vs. 6%, p <.001). Bail-out stenting rates were lower in the LA + DCB group (32% vs. 57%, p =.008). LA + DCB was superior (HR: 0.57; 95% CI: 0.34–0.9, p =.027) for the composite outcome of 2-year TLR or restenosis. The 12-month KM estimates for freedom from TLR or restenosis were 66% in the LA + DCB group versus 46% in the LA + BA group. The 24-month KM estimates were 45% in the LA + DCB group versus 24% in the LA + BA group. Conclusions: The combination of DCB + LA was associated with decreased rates of bail-out stenting and improved 2-year TLR or restenosis rates. Randomized clinical trials examining the DCB + LA combination for FP-ISR are needed. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Laser atherectomy and drug-coated balloons for the treatment of femoropopliteal in-stent restenosis: 2-Year outcomes ###Abstract: Background: Femoropopliteal (FP) artery is one of the most anatomically challenging areas for sustained stent patency. The incidence of FP in-stent restenosis (ISR) is estimated at 50% at 24 months. Prior studies have shown that lesion debulking with laser atherectomy (LA) combined with drug coated balloon (DCB) have superior outcomes compared to LA + balloon angioplasty (BA) ISR, but there have not been studies evaluating 2-year outcomes. Methods: This was a dual-center retrospective cohort study that compared patients with FP-ISR treated with LA + DCB versus LA + BA. Cox regression analysis was used to examine 2-year outcomes of target lesion revascularization (TLR) and the composite outcome of TLR or restenosis. Multivariable analysis was performed for clinical and statistically significant (in the univariate analysis) variables. Results: One hundred and seventeen consecutive patients with Tosaka II (n = 32) and III (n = 85) ISR were analyzed. Sixty-six patients were treated with LA + DCB and 51 with LA + BA. The LA + DCB group had more lesions with moderate to severe calcification (58% vs. 13%; p <.0001). The LA + DCB group was more likely to be treated with the use of embolic protection devices (64% vs. 23%, p <.001) and cutting balloons (61% vs. 6%, p <.001). Bail-out stenting rates were lower in the LA + DCB group (32% vs. 57%, p =.008). LA + DCB was superior (HR: 0.57; 95% CI: 0.34–0.9, p =.027) for the composite outcome of 2-year TLR or restenosis. The 12-month KM estimates for freedom from TLR or restenosis were 66% in the LA + DCB group versus 46% in the LA + BA group. The 24-month KM estimates were 45% in the LA + DCB group versus 24% in the LA + BA group. Conclusions: The combination of DCB + LA was associated with decreased rates of bail-out stenting and improved 2-year TLR or restenosis rates. Randomized clinical trials examining the DCB + LA combination for FP-ISR are needed. [/INST] Include </s>
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Kolber 2017
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Atherectomy Prior to Drug-Eluting-Balloon Angioplasty in a Calcified Vessel
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Endovascular treatment options for peripheral arterial disease of the lower extremity include percutaneous transluminal angioplasty, stent implantation, and atherectomy. Drug-eluting balloons (DEB) show promise in reducing long-Term restenosis and target lesion revascularization rates by limiting postprocedural neointimal hyperplasia. However, dense calcification is thought to act as a barrier to successful deposition of antiproliferative drug. Atherectomy prior to DEB angioplasty is one approach to reduce mural calcification and improve the efficacy of drug delivery.
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Include
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DI3 - Case Report
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Atherectomy Prior to Drug-Eluting-Balloon Angioplasty in a Calcified Vessel ###Abstract: Endovascular treatment options for peripheral arterial disease of the lower extremity include percutaneous transluminal angioplasty, stent implantation, and atherectomy. Drug-eluting balloons (DEB) show promise in reducing long-Term restenosis and target lesion revascularization rates by limiting postprocedural neointimal hyperplasia. However, dense calcification is thought to act as a barrier to successful deposition of antiproliferative drug. Atherectomy prior to DEB angioplasty is one approach to reduce mural calcification and improve the efficacy of drug delivery. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Atherectomy Prior to Drug-Eluting-Balloon Angioplasty in a Calcified Vessel ###Abstract: Endovascular treatment options for peripheral arterial disease of the lower extremity include percutaneous transluminal angioplasty, stent implantation, and atherectomy. Drug-eluting balloons (DEB) show promise in reducing long-Term restenosis and target lesion revascularization rates by limiting postprocedural neointimal hyperplasia. However, dense calcification is thought to act as a barrier to successful deposition of antiproliferative drug. Atherectomy prior to DEB angioplasty is one approach to reduce mural calcification and improve the efficacy of drug delivery. [/INST] Include </s>
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Krankenberg 2015
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Drug-coated balloon versus standard balloon for superficial femoral artery in-stent restenosis: The randomized Femoral Artery In-Stent Restenosis (FAIR) trial
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Background - Drug-coated balloon angioplasty (DCBA) was shown to be superior to standard balloon angioplasty (POBA) in terms of restenosis prevention for de novo superficial femoral artery disease. For in-stent restenosis, the benefit of DCBA over POBA remains uncertain. Methods and Results - One hundred nineteen patients with superficial femoral artery in-stent restenosis and chronic limb ischemia were recruited over 34 months at 5 German clinical sites and prospectively randomized to either DCBA (n=62) or POBA (n=57). Mean lesion length was 82.2±68.4 mm. Thirty-four (28.6%) lesions were totally occluded; 30 (25.2%) were moderately or heavily calcified. Clinical and duplex ultrasound follow-up was conducted at 6 and 12 months. The primary end point of recurrent in-stent restenosis assessed by ultrasound at 6 months was 15.4% (8 of 52) in the DCBA and 44.7% (21 of 47) in the POBA group (P=0.002). Freedom from target lesion revascularization was 96.4% versus 81.0% (P=0.0117) at 6 months and 90.8% versus 52.6% (P<0.0001) at 12 months, respectively. At 12 months, clinical improvement by ≥1 Rutherford category without the need for target lesion revascularization was observed in 35 of 45 DCBA patients (77.8%) and 23 of 44 POBA patients (52.3%; P=0.015). No major amputation was needed. Two patients in the DCBA and 3 patients in the POBA group died. No death was procedure related. Conclusions - DCBA for superficial femoral artery in-stent restenosis is associated with less recurrent restenosis and a better clinical outcome than POBA without an apparent difference in safety.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon versus standard balloon for superficial femoral artery in-stent restenosis: The randomized Femoral Artery In-Stent Restenosis (FAIR) trial ###Abstract: Background - Drug-coated balloon angioplasty (DCBA) was shown to be superior to standard balloon angioplasty (POBA) in terms of restenosis prevention for de novo superficial femoral artery disease. For in-stent restenosis, the benefit of DCBA over POBA remains uncertain. Methods and Results - One hundred nineteen patients with superficial femoral artery in-stent restenosis and chronic limb ischemia were recruited over 34 months at 5 German clinical sites and prospectively randomized to either DCBA (n=62) or POBA (n=57). Mean lesion length was 82.2±68.4 mm. Thirty-four (28.6%) lesions were totally occluded; 30 (25.2%) were moderately or heavily calcified. Clinical and duplex ultrasound follow-up was conducted at 6 and 12 months. The primary end point of recurrent in-stent restenosis assessed by ultrasound at 6 months was 15.4% (8 of 52) in the DCBA and 44.7% (21 of 47) in the POBA group (P=0.002). Freedom from target lesion revascularization was 96.4% versus 81.0% (P=0.0117) at 6 months and 90.8% versus 52.6% (P<0.0001) at 12 months, respectively. At 12 months, clinical improvement by ≥1 Rutherford category without the need for target lesion revascularization was observed in 35 of 45 DCBA patients (77.8%) and 23 of 44 POBA patients (52.3%; P=0.015). No major amputation was needed. Two patients in the DCBA and 3 patients in the POBA group died. No death was procedure related. Conclusions - DCBA for superficial femoral artery in-stent restenosis is associated with less recurrent restenosis and a better clinical outcome than POBA without an apparent difference in safety. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon versus standard balloon for superficial femoral artery in-stent restenosis: The randomized Femoral Artery In-Stent Restenosis (FAIR) trial ###Abstract: Background - Drug-coated balloon angioplasty (DCBA) was shown to be superior to standard balloon angioplasty (POBA) in terms of restenosis prevention for de novo superficial femoral artery disease. For in-stent restenosis, the benefit of DCBA over POBA remains uncertain. Methods and Results - One hundred nineteen patients with superficial femoral artery in-stent restenosis and chronic limb ischemia were recruited over 34 months at 5 German clinical sites and prospectively randomized to either DCBA (n=62) or POBA (n=57). Mean lesion length was 82.2±68.4 mm. Thirty-four (28.6%) lesions were totally occluded; 30 (25.2%) were moderately or heavily calcified. Clinical and duplex ultrasound follow-up was conducted at 6 and 12 months. The primary end point of recurrent in-stent restenosis assessed by ultrasound at 6 months was 15.4% (8 of 52) in the DCBA and 44.7% (21 of 47) in the POBA group (P=0.002). Freedom from target lesion revascularization was 96.4% versus 81.0% (P=0.0117) at 6 months and 90.8% versus 52.6% (P<0.0001) at 12 months, respectively. At 12 months, clinical improvement by ≥1 Rutherford category without the need for target lesion revascularization was observed in 35 of 45 DCBA patients (77.8%) and 23 of 44 POBA patients (52.3%; P=0.015). No major amputation was needed. Two patients in the DCBA and 3 patients in the POBA group died. No death was procedure related. Conclusions - DCBA for superficial femoral artery in-stent restenosis is associated with less recurrent restenosis and a better clinical outcome than POBA without an apparent difference in safety. [/INST] Include </s>
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Lai 2017
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Modified drug-eluting balloon angioplasty to treat high-risk carotid in-stent restenosis
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Carotid artery stenting is commonly used to treat carotid artery stenosis. However, carotid in-stent restenosis remains a challenging problem. Herein, we report a difficult case of recurrent severe carotid in-stent restenosis with total contralateral internal carotid artery occlusion treated with repeat drug-eluting balloon inflations. The outcome after one year of follow-up showed a good result.
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Include
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DI3 - Case Report
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Modified drug-eluting balloon angioplasty to treat high-risk carotid in-stent restenosis ###Abstract: Carotid artery stenting is commonly used to treat carotid artery stenosis. However, carotid in-stent restenosis remains a challenging problem. Herein, we report a difficult case of recurrent severe carotid in-stent restenosis with total contralateral internal carotid artery occlusion treated with repeat drug-eluting balloon inflations. The outcome after one year of follow-up showed a good result. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Modified drug-eluting balloon angioplasty to treat high-risk carotid in-stent restenosis ###Abstract: Carotid artery stenting is commonly used to treat carotid artery stenosis. However, carotid in-stent restenosis remains a challenging problem. Herein, we report a difficult case of recurrent severe carotid in-stent restenosis with total contralateral internal carotid artery occlusion treated with repeat drug-eluting balloon inflations. The outcome after one year of follow-up showed a good result. [/INST] Include </s>
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Laird 2015
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Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA
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Background Evidence from large, randomized, controlled peripheral artery disease trials reporting long-term outcomes using drug-coated balloons (DCBs) is limited. Previously, the DCB showed favorable 1-year outcomes compared with conventional percutaneous transluminal angioplasty (PTA), yet durability of the treatment effect with DCBs remains unknown. Objectives This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions. Methods We enrolled 331 patients with symptomatic (Rutherford 2 to 4) femoropopliteal lesions up to 18 cm in length. Patients were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The 24-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), major adverse events, and quality of life and functional outcomes as assessed by the EuroQOL-5D quality-of-life questionnaire, walking impairment questionnaire, and 6-min walk test. Results At 24 months, patients treated with DCB showed significantly higher primary patency when compared with PTA (78.9% vs. 50.1%; p < 0.001). The rates of CD-TLR were 9.1% and 28.3% (p < 0.001) for the DCB and PTA groups, respectively. The overall mortality rate in the DCB group was 8.1% versus 0.9% in the PTA group (p = 0.008). There were no device- or procedure-related deaths and no major amputations in either group through 24-month follow-up. The rate of vessel thrombosis was low (1.5% DCB vs. 3.8% PTA; p = 0.243), with no new events reported between 1 and 2 years. Both groups showed similar functional improvement at 2 years, although DCB patients achieved this level of function with 58% fewer reinterventions. Conclusions The 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency, lower CD-TLR, and similar functional status improvement with fewer repeat interventions. (Randomized Trial of IN.PACT Admiral Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; and IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461)
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA ###Abstract: Background Evidence from large, randomized, controlled peripheral artery disease trials reporting long-term outcomes using drug-coated balloons (DCBs) is limited. Previously, the DCB showed favorable 1-year outcomes compared with conventional percutaneous transluminal angioplasty (PTA), yet durability of the treatment effect with DCBs remains unknown. Objectives This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions. Methods We enrolled 331 patients with symptomatic (Rutherford 2 to 4) femoropopliteal lesions up to 18 cm in length. Patients were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The 24-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), major adverse events, and quality of life and functional outcomes as assessed by the EuroQOL-5D quality-of-life questionnaire, walking impairment questionnaire, and 6-min walk test. Results At 24 months, patients treated with DCB showed significantly higher primary patency when compared with PTA (78.9% vs. 50.1%; p < 0.001). The rates of CD-TLR were 9.1% and 28.3% (p < 0.001) for the DCB and PTA groups, respectively. The overall mortality rate in the DCB group was 8.1% versus 0.9% in the PTA group (p = 0.008). There were no device- or procedure-related deaths and no major amputations in either group through 24-month follow-up. The rate of vessel thrombosis was low (1.5% DCB vs. 3.8% PTA; p = 0.243), with no new events reported between 1 and 2 years. Both groups showed similar functional improvement at 2 years, although DCB patients achieved this level of function with 58% fewer reinterventions. Conclusions The 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency, lower CD-TLR, and similar functional status improvement with fewer repeat interventions. (Randomized Trial of IN.PACT Admiral Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; and IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461) [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA ###Abstract: Background Evidence from large, randomized, controlled peripheral artery disease trials reporting long-term outcomes using drug-coated balloons (DCBs) is limited. Previously, the DCB showed favorable 1-year outcomes compared with conventional percutaneous transluminal angioplasty (PTA), yet durability of the treatment effect with DCBs remains unknown. Objectives This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions. Methods We enrolled 331 patients with symptomatic (Rutherford 2 to 4) femoropopliteal lesions up to 18 cm in length. Patients were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The 24-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), major adverse events, and quality of life and functional outcomes as assessed by the EuroQOL-5D quality-of-life questionnaire, walking impairment questionnaire, and 6-min walk test. Results At 24 months, patients treated with DCB showed significantly higher primary patency when compared with PTA (78.9% vs. 50.1%; p < 0.001). The rates of CD-TLR were 9.1% and 28.3% (p < 0.001) for the DCB and PTA groups, respectively. The overall mortality rate in the DCB group was 8.1% versus 0.9% in the PTA group (p = 0.008). There were no device- or procedure-related deaths and no major amputations in either group through 24-month follow-up. The rate of vessel thrombosis was low (1.5% DCB vs. 3.8% PTA; p = 0.243), with no new events reported between 1 and 2 years. Both groups showed similar functional improvement at 2 years, although DCB patients achieved this level of function with 58% fewer reinterventions. Conclusions The 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency, lower CD-TLR, and similar functional status improvement with fewer repeat interventions. (Randomized Trial of IN.PACT Admiral Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; and IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461) [/INST] Include </s>
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Laird 2019
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Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions: Five-Year Outcomes from the IN.PACT SFA Randomized Trial
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Background: While randomized trials have demonstrated the superiority of drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal peripheral artery disease, the long-term durability of DCB angioplasty remains uncertain. Methods and Results: IN.PACT SFA is a prospective, multicenter, randomized single-blinded trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) that enrolled 331 subjects with symptomatic (Rutherford 2-4) femoropopliteal lesions. Subjects were randomly assigned 2:1 to the IN.PACT Admiral DCB or PTA. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the primary safety end point, and major adverse events. Through 5 years, patients treated with the IN.PACT Admiral DCB demonstrated a sustained treatment effect with superior freedom from clinically driven target lesion revascularization when compared with PTA (Kaplan-Meier estimate of 74.5% versus 65.3%; log-rank P=0.020). The primary safety composite was achieved in 70.7% of subjects in the DCB and 59.6% in the PTA groups (P=0.068). The major adverse event rate was 42.9% for DCB and 48.1% for PTA (P=0.459). There were no device-or procedure-related deaths in either group as adjudicated by an independent and blinded Clinical Events Committee. Conclusions: The IN.PACT SFA randomized trial demonstrates that the IN.PACT Admiral DCB continues to perform better than PTA through 5 years with higher freedom from clinically driven target lesion revascularization. The sustained safety and effectiveness profile of this DCB supports its use as a preferred treatment choice compared with PTA for femoropopliteal lesions. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01175850 (IN.PACT SFA phase I) and NCT01566461 (IN.PACT SFA phase II).
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions: Five-Year Outcomes from the IN.PACT SFA Randomized Trial ###Abstract: Background: While randomized trials have demonstrated the superiority of drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal peripheral artery disease, the long-term durability of DCB angioplasty remains uncertain. Methods and Results: IN.PACT SFA is a prospective, multicenter, randomized single-blinded trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) that enrolled 331 subjects with symptomatic (Rutherford 2-4) femoropopliteal lesions. Subjects were randomly assigned 2:1 to the IN.PACT Admiral DCB or PTA. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the primary safety end point, and major adverse events. Through 5 years, patients treated with the IN.PACT Admiral DCB demonstrated a sustained treatment effect with superior freedom from clinically driven target lesion revascularization when compared with PTA (Kaplan-Meier estimate of 74.5% versus 65.3%; log-rank P=0.020). The primary safety composite was achieved in 70.7% of subjects in the DCB and 59.6% in the PTA groups (P=0.068). The major adverse event rate was 42.9% for DCB and 48.1% for PTA (P=0.459). There were no device-or procedure-related deaths in either group as adjudicated by an independent and blinded Clinical Events Committee. Conclusions: The IN.PACT SFA randomized trial demonstrates that the IN.PACT Admiral DCB continues to perform better than PTA through 5 years with higher freedom from clinically driven target lesion revascularization. The sustained safety and effectiveness profile of this DCB supports its use as a preferred treatment choice compared with PTA for femoropopliteal lesions. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01175850 (IN.PACT SFA phase I) and NCT01566461 (IN.PACT SFA phase II). [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions: Five-Year Outcomes from the IN.PACT SFA Randomized Trial ###Abstract: Background: While randomized trials have demonstrated the superiority of drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal peripheral artery disease, the long-term durability of DCB angioplasty remains uncertain. Methods and Results: IN.PACT SFA is a prospective, multicenter, randomized single-blinded trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) that enrolled 331 subjects with symptomatic (Rutherford 2-4) femoropopliteal lesions. Subjects were randomly assigned 2:1 to the IN.PACT Admiral DCB or PTA. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the primary safety end point, and major adverse events. Through 5 years, patients treated with the IN.PACT Admiral DCB demonstrated a sustained treatment effect with superior freedom from clinically driven target lesion revascularization when compared with PTA (Kaplan-Meier estimate of 74.5% versus 65.3%; log-rank P=0.020). The primary safety composite was achieved in 70.7% of subjects in the DCB and 59.6% in the PTA groups (P=0.068). The major adverse event rate was 42.9% for DCB and 48.1% for PTA (P=0.459). There were no device-or procedure-related deaths in either group as adjudicated by an independent and blinded Clinical Events Committee. Conclusions: The IN.PACT SFA randomized trial demonstrates that the IN.PACT Admiral DCB continues to perform better than PTA through 5 years with higher freedom from clinically driven target lesion revascularization. The sustained safety and effectiveness profile of this DCB supports its use as a preferred treatment choice compared with PTA for femoropopliteal lesions. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01175850 (IN.PACT SFA phase I) and NCT01566461 (IN.PACT SFA phase II). [/INST] Include </s>
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Lake 2017
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Acute hypersensitivity reaction to femoral drug-coated balloons
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Summary: We describe a case of an acute hypersensitivity reaction to a paclitaxel-coated balloon used in the peripheral arterial circulation. Clinicians using these products should be aware of this potential risk.
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Include
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Acute hypersensitivity reaction to femoral drug-coated balloons ###Abstract: Summary: We describe a case of an acute hypersensitivity reaction to a paclitaxel-coated balloon used in the peripheral arterial circulation. Clinicians using these products should be aware of this potential risk. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Acute hypersensitivity reaction to femoral drug-coated balloons ###Abstract: Summary: We describe a case of an acute hypersensitivity reaction to a paclitaxel-coated balloon used in the peripheral arterial circulation. Clinicians using these products should be aware of this potential risk. [/INST] Include </s>
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Lee 2020a
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Outcomes of Adjunctive Drug-Coated Versus Uncoated Balloon after Atherectomy in Femoropopliteal Artery Disease
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Background: The purpose of this study is to evaluate outcomes using drug-coated balloon (DCB) in comparison with uncoated balloon as adjunctive treatment after atherectomy for femoropopliteal artery lesions. Methods: This single-center retrospective and prospective study included 115 patients with 126 femoropopliteal artery lesions treated with endovascular treatment using atherectomy. Of these, 58 patients received adjunctive DCB after atherectomy (group A) and 57 patients were managed with uncoated balloon after atherectomy (group B). Immediate and late clinical outcomes were compared. Results: Baseline clinical and lesion data were comparable between the 2 groups. However, group A included more uses of rotational atherectomy (43.9% vs. 1.7%, P < 0.001) or embolization protection filter (53.0% vs. 6.7%, P = 0.001), and fewer cases requiring provisional stenting (4.5% vs. 18.3%, P = 0.014). Clinical primary patency at 1 year was significantly higher in group A than in group B (76.3% vs. 61.1%, P = 0.039). There was a trend toward higher 1-year target lesion revascularization (TLR)-free survival in group A (89.8% vs. 77.9% at 1 year, P = 0.275) without statistical significance. Proportional hazards regression analysis indicated that age (hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.90–0.99, P = 0.016) and provisional stenting (HR 9.78, 95% CI 2.20–43.46, P = 0.003) were independent factors associated with restenosis after combined treatment with atherectomy and DCB. Conclusions: In femoropopliteal artery disease, the combination of atherectomy with adjunctive DCB achieved better clinical outcomes in terms of clinical primary patency compared to atherectomy plus uncoated balloon while TLR-free survival may also be improved.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Outcomes of Adjunctive Drug-Coated Versus Uncoated Balloon after Atherectomy in Femoropopliteal Artery Disease ###Abstract: Background: The purpose of this study is to evaluate outcomes using drug-coated balloon (DCB) in comparison with uncoated balloon as adjunctive treatment after atherectomy for femoropopliteal artery lesions. Methods: This single-center retrospective and prospective study included 115 patients with 126 femoropopliteal artery lesions treated with endovascular treatment using atherectomy. Of these, 58 patients received adjunctive DCB after atherectomy (group A) and 57 patients were managed with uncoated balloon after atherectomy (group B). Immediate and late clinical outcomes were compared. Results: Baseline clinical and lesion data were comparable between the 2 groups. However, group A included more uses of rotational atherectomy (43.9% vs. 1.7%, P < 0.001) or embolization protection filter (53.0% vs. 6.7%, P = 0.001), and fewer cases requiring provisional stenting (4.5% vs. 18.3%, P = 0.014). Clinical primary patency at 1 year was significantly higher in group A than in group B (76.3% vs. 61.1%, P = 0.039). There was a trend toward higher 1-year target lesion revascularization (TLR)-free survival in group A (89.8% vs. 77.9% at 1 year, P = 0.275) without statistical significance. Proportional hazards regression analysis indicated that age (hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.90–0.99, P = 0.016) and provisional stenting (HR 9.78, 95% CI 2.20–43.46, P = 0.003) were independent factors associated with restenosis after combined treatment with atherectomy and DCB. Conclusions: In femoropopliteal artery disease, the combination of atherectomy with adjunctive DCB achieved better clinical outcomes in terms of clinical primary patency compared to atherectomy plus uncoated balloon while TLR-free survival may also be improved. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Outcomes of Adjunctive Drug-Coated Versus Uncoated Balloon after Atherectomy in Femoropopliteal Artery Disease ###Abstract: Background: The purpose of this study is to evaluate outcomes using drug-coated balloon (DCB) in comparison with uncoated balloon as adjunctive treatment after atherectomy for femoropopliteal artery lesions. Methods: This single-center retrospective and prospective study included 115 patients with 126 femoropopliteal artery lesions treated with endovascular treatment using atherectomy. Of these, 58 patients received adjunctive DCB after atherectomy (group A) and 57 patients were managed with uncoated balloon after atherectomy (group B). Immediate and late clinical outcomes were compared. Results: Baseline clinical and lesion data were comparable between the 2 groups. However, group A included more uses of rotational atherectomy (43.9% vs. 1.7%, P < 0.001) or embolization protection filter (53.0% vs. 6.7%, P = 0.001), and fewer cases requiring provisional stenting (4.5% vs. 18.3%, P = 0.014). Clinical primary patency at 1 year was significantly higher in group A than in group B (76.3% vs. 61.1%, P = 0.039). There was a trend toward higher 1-year target lesion revascularization (TLR)-free survival in group A (89.8% vs. 77.9% at 1 year, P = 0.275) without statistical significance. Proportional hazards regression analysis indicated that age (hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.90–0.99, P = 0.016) and provisional stenting (HR 9.78, 95% CI 2.20–43.46, P = 0.003) were independent factors associated with restenosis after combined treatment with atherectomy and DCB. Conclusions: In femoropopliteal artery disease, the combination of atherectomy with adjunctive DCB achieved better clinical outcomes in terms of clinical primary patency compared to atherectomy plus uncoated balloon while TLR-free survival may also be improved. [/INST] Include </s>
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Lee 2020b
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Drug Eluting Stent vs. Drug Coated Balloon for Native Femoropopliteal Artery Disease: A Two Centre Experience
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Objective: There have been limited clinical trials comparing drug eluting stents (DESs) and drug coated balloons (DCBs) in the treatment of femoropopliteal artery disease. This two centre retrospective and prospective cohort study sought to compare DES with DCB for the treatment of native femoropopliteal artery disease. Methods: A total of 288 limbs (242 patients) with native femoropopliteal artery disease were treated with DESs (Zilver PTX; 102 limbs) or DCBs (IN.PACT Admiral; 186 limbs) in two Korean endovascular centres between 19 January 2013 and 5 May 2018 and followed for a median duration of 19.6 months. The primary endpoint was primary clinical patency. Propensity score matching (PSM, 162 limbs) and inverse probability weighted (IPW) adjustment were performed to adjust for confounding baseline characteristics. Results: The DCB group had fewer lesions with Trans-Atlantic Inter-Society Consensus (TASC) II type C/D (55.9% vs. 70.6%, p =.021) or total occlusions (43.5% vs. 77.5%, p <.001) and showed shorter lesion lengths (164.2 ± 105.4 mm vs. 194.8 ± 86.8 mm, p =.009) than the DES group. After PSM, baseline clinical and lesion characteristics of the two groups were comparable except for larger reference vessel diameter in the DES group (5.4 ± 0.6 vs. 5.1 ± 0.7, p =.025). Adjunctive atherectomy was performed in 32.1% of the DCB group and in 2.5% of the DES group (p <.001). The provisional stenting was required in 14.8% of the DCB group. At two year follow up, the DCB group showed higher primary clinical patency (74.6% vs. 56.7%, hazard ratio [HR] 0.51, 95% confidence interval [CI] 0.27–0.96, p =.032) and freedom from target lesion revascularisation (85.9% vs. 71.3%, HR 0.39, 95% CI 0.17–0.89, p =.021) than the DES group. Survival from all cause death did not differ between groups (87.6% vs. 92.1%, HR 1.85, 95% CI 0.62–5.52, p =.26). Conclusion: In this two centre cohort, DCBs with selective use of adjunctive atherectomy achieved more favourable outcomes than DESs for native femoropopliteal artery disease.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug Eluting Stent vs. Drug Coated Balloon for Native Femoropopliteal Artery Disease: A Two Centre Experience ###Abstract: Objective: There have been limited clinical trials comparing drug eluting stents (DESs) and drug coated balloons (DCBs) in the treatment of femoropopliteal artery disease. This two centre retrospective and prospective cohort study sought to compare DES with DCB for the treatment of native femoropopliteal artery disease. Methods: A total of 288 limbs (242 patients) with native femoropopliteal artery disease were treated with DESs (Zilver PTX; 102 limbs) or DCBs (IN.PACT Admiral; 186 limbs) in two Korean endovascular centres between 19 January 2013 and 5 May 2018 and followed for a median duration of 19.6 months. The primary endpoint was primary clinical patency. Propensity score matching (PSM, 162 limbs) and inverse probability weighted (IPW) adjustment were performed to adjust for confounding baseline characteristics. Results: The DCB group had fewer lesions with Trans-Atlantic Inter-Society Consensus (TASC) II type C/D (55.9% vs. 70.6%, p =.021) or total occlusions (43.5% vs. 77.5%, p <.001) and showed shorter lesion lengths (164.2 ± 105.4 mm vs. 194.8 ± 86.8 mm, p =.009) than the DES group. After PSM, baseline clinical and lesion characteristics of the two groups were comparable except for larger reference vessel diameter in the DES group (5.4 ± 0.6 vs. 5.1 ± 0.7, p =.025). Adjunctive atherectomy was performed in 32.1% of the DCB group and in 2.5% of the DES group (p <.001). The provisional stenting was required in 14.8% of the DCB group. At two year follow up, the DCB group showed higher primary clinical patency (74.6% vs. 56.7%, hazard ratio [HR] 0.51, 95% confidence interval [CI] 0.27–0.96, p =.032) and freedom from target lesion revascularisation (85.9% vs. 71.3%, HR 0.39, 95% CI 0.17–0.89, p =.021) than the DES group. Survival from all cause death did not differ between groups (87.6% vs. 92.1%, HR 1.85, 95% CI 0.62–5.52, p =.26). Conclusion: In this two centre cohort, DCBs with selective use of adjunctive atherectomy achieved more favourable outcomes than DESs for native femoropopliteal artery disease. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug Eluting Stent vs. Drug Coated Balloon for Native Femoropopliteal Artery Disease: A Two Centre Experience ###Abstract: Objective: There have been limited clinical trials comparing drug eluting stents (DESs) and drug coated balloons (DCBs) in the treatment of femoropopliteal artery disease. This two centre retrospective and prospective cohort study sought to compare DES with DCB for the treatment of native femoropopliteal artery disease. Methods: A total of 288 limbs (242 patients) with native femoropopliteal artery disease were treated with DESs (Zilver PTX; 102 limbs) or DCBs (IN.PACT Admiral; 186 limbs) in two Korean endovascular centres between 19 January 2013 and 5 May 2018 and followed for a median duration of 19.6 months. The primary endpoint was primary clinical patency. Propensity score matching (PSM, 162 limbs) and inverse probability weighted (IPW) adjustment were performed to adjust for confounding baseline characteristics. Results: The DCB group had fewer lesions with Trans-Atlantic Inter-Society Consensus (TASC) II type C/D (55.9% vs. 70.6%, p =.021) or total occlusions (43.5% vs. 77.5%, p <.001) and showed shorter lesion lengths (164.2 ± 105.4 mm vs. 194.8 ± 86.8 mm, p =.009) than the DES group. After PSM, baseline clinical and lesion characteristics of the two groups were comparable except for larger reference vessel diameter in the DES group (5.4 ± 0.6 vs. 5.1 ± 0.7, p =.025). Adjunctive atherectomy was performed in 32.1% of the DCB group and in 2.5% of the DES group (p <.001). The provisional stenting was required in 14.8% of the DCB group. At two year follow up, the DCB group showed higher primary clinical patency (74.6% vs. 56.7%, hazard ratio [HR] 0.51, 95% confidence interval [CI] 0.27–0.96, p =.032) and freedom from target lesion revascularisation (85.9% vs. 71.3%, HR 0.39, 95% CI 0.17–0.89, p =.021) than the DES group. Survival from all cause death did not differ between groups (87.6% vs. 92.1%, HR 1.85, 95% CI 0.62–5.52, p =.26). Conclusion: In this two centre cohort, DCBs with selective use of adjunctive atherectomy achieved more favourable outcomes than DESs for native femoropopliteal artery disease. [/INST] Include </s>
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Liao 2020
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A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts
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Objective: Paclitaxel-coated balloons are used to reduce neointimal hyperplasia in native arteriovenous (AV) fistulas. However, no study specifically evaluated their effect on venous anastomotic stenosis of dialysis grafts. We aimed to compare the efficacy of angioplasty with drug-coated balloons (DCBs) and angioplasty with conventional balloons (CBs) for venous anastomotic stenosis in dysfunctional AV grafts. Methods: In this investigator-initiated, single-center, single-blinded, prospective randomized controlled trial, we randomly assigned 44 patients who had venous anastomotic stenosis to undergo angioplasty with DCBs (n = 22) or CBs (n = 22) from July 2015 to August 2018. Access function was observed per the hemodialysis center's protocols; ancillary angiographic follow-up was performed every 2 months for 1 year after the interventions. The primary end point was target lesion primary patency at 6 months. Secondary outcomes included anatomic and clinical success after angioplasty, circuit primary patency at 6 months and 1 year, and target lesion primary patency at 1 year. Results: At 6 months, target lesion primary patency in the DCB group was significantly greater than that in the CB group (41% vs 9%; hazard ratio [HR], 0.393; 95% confidence interval [CI], 0.194-0.795; P =.006), as was the primary patency of the entire access circuit (36% vs 9%; HR, 0.436; 95% CI, 0.218-0.870; P =.013). At 1 year, the target lesion primary patency in the DCB group remained greater than that in the CB group (23% vs 9%; HR, 0.477; 95% CI, 0.243-0.933; P =.019) but not the primary patency of the access circuit (14% vs 9%; HR, 0.552; 95% CI, 0.288-1.059; P =.056). No difference in anatomic or clinical success was observed; no major complications were noted. Conclusions: Angioplasty with DCBs showed a modest improvement in primary patency of venous anastomotic stenosis and all dialysis AV grafts at 6 months. The short-term benefit was not durable to 1 year, and reinterventions were eventually needed.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts ###Abstract: Objective: Paclitaxel-coated balloons are used to reduce neointimal hyperplasia in native arteriovenous (AV) fistulas. However, no study specifically evaluated their effect on venous anastomotic stenosis of dialysis grafts. We aimed to compare the efficacy of angioplasty with drug-coated balloons (DCBs) and angioplasty with conventional balloons (CBs) for venous anastomotic stenosis in dysfunctional AV grafts. Methods: In this investigator-initiated, single-center, single-blinded, prospective randomized controlled trial, we randomly assigned 44 patients who had venous anastomotic stenosis to undergo angioplasty with DCBs (n = 22) or CBs (n = 22) from July 2015 to August 2018. Access function was observed per the hemodialysis center's protocols; ancillary angiographic follow-up was performed every 2 months for 1 year after the interventions. The primary end point was target lesion primary patency at 6 months. Secondary outcomes included anatomic and clinical success after angioplasty, circuit primary patency at 6 months and 1 year, and target lesion primary patency at 1 year. Results: At 6 months, target lesion primary patency in the DCB group was significantly greater than that in the CB group (41% vs 9%; hazard ratio [HR], 0.393; 95% confidence interval [CI], 0.194-0.795; P =.006), as was the primary patency of the entire access circuit (36% vs 9%; HR, 0.436; 95% CI, 0.218-0.870; P =.013). At 1 year, the target lesion primary patency in the DCB group remained greater than that in the CB group (23% vs 9%; HR, 0.477; 95% CI, 0.243-0.933; P =.019) but not the primary patency of the access circuit (14% vs 9%; HR, 0.552; 95% CI, 0.288-1.059; P =.056). No difference in anatomic or clinical success was observed; no major complications were noted. Conclusions: Angioplasty with DCBs showed a modest improvement in primary patency of venous anastomotic stenosis and all dialysis AV grafts at 6 months. The short-term benefit was not durable to 1 year, and reinterventions were eventually needed. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts ###Abstract: Objective: Paclitaxel-coated balloons are used to reduce neointimal hyperplasia in native arteriovenous (AV) fistulas. However, no study specifically evaluated their effect on venous anastomotic stenosis of dialysis grafts. We aimed to compare the efficacy of angioplasty with drug-coated balloons (DCBs) and angioplasty with conventional balloons (CBs) for venous anastomotic stenosis in dysfunctional AV grafts. Methods: In this investigator-initiated, single-center, single-blinded, prospective randomized controlled trial, we randomly assigned 44 patients who had venous anastomotic stenosis to undergo angioplasty with DCBs (n = 22) or CBs (n = 22) from July 2015 to August 2018. Access function was observed per the hemodialysis center's protocols; ancillary angiographic follow-up was performed every 2 months for 1 year after the interventions. The primary end point was target lesion primary patency at 6 months. Secondary outcomes included anatomic and clinical success after angioplasty, circuit primary patency at 6 months and 1 year, and target lesion primary patency at 1 year. Results: At 6 months, target lesion primary patency in the DCB group was significantly greater than that in the CB group (41% vs 9%; hazard ratio [HR], 0.393; 95% confidence interval [CI], 0.194-0.795; P =.006), as was the primary patency of the entire access circuit (36% vs 9%; HR, 0.436; 95% CI, 0.218-0.870; P =.013). At 1 year, the target lesion primary patency in the DCB group remained greater than that in the CB group (23% vs 9%; HR, 0.477; 95% CI, 0.243-0.933; P =.019) but not the primary patency of the access circuit (14% vs 9%; HR, 0.552; 95% CI, 0.288-1.059; P =.056). No difference in anatomic or clinical success was observed; no major complications were noted. Conclusions: Angioplasty with DCBs showed a modest improvement in primary patency of venous anastomotic stenosis and all dialysis AV grafts at 6 months. The short-term benefit was not durable to 1 year, and reinterventions were eventually needed. [/INST] Include </s>
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Liistro 2013b
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Drug-eluting balloon in peripheral intervention for the superficial femoral artery: The DEBATE-SFA randomized trial (Drug Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery)
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Objectives This study sought to compare paclitaxel-eluting balloon (PEB) with conventional percutaneous transluminal angioplasty (PTA), followed by systematic implantation of a self-expanding nitinol bare-metal stent (BMS) in patients at risk for restenosis. Background PTA is an effective strategy for treating atherosclerosis of the femoropopliteal axis (FPA). Whereas PEB have shown advantage over uncoated balloons in the treatment of simple lesions, it is unknown whether these results are applicable to complex degrees of FPA atheroma. Methods A total of 104 patients (110 FPA lesions in 110 limbs) were randomly assigned to either PEB + BMS or PTA + BMS. The primary endpoint was 12-month binary restenosis. Secondary endpoints were freedom from target lesion revascularization and major amputation. Post hoc subanalyses were performed for the comparison of long (≥100 mm) versus short lesions and true lumen versus subintimal approach. Results Mean lesion length was 94 ± 60 versus 96 ± 69 mm in the PEB + BMS and PTA + BMS groups (p = 0.8), respectively. The primary endpoint occurred in 9 (17%) versus 26 (47.3%) of lesions in the PEB + BMS and PTA + BMS groups (p = 0.008), respectively. A near-significant (p = 0.07) 1-year freedom from target lesion revascularization advantage was observed in the PEB + BMS group. No major amputation occurred. No significant difference was observed according to lesion characteristics or technical approach. Conclusions Pre-dilation with PEB angioplasty prior to BMS implantation, as compared to PTA + BMS in complex FPA lesions, reduces restenosis and target lesion revascularization at 12-month follow-up. Restenosis reduction is maintained irrespective of lesion length and recanalization technique. (Drug Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery [DEBATE-SFA]; NCT01556542). © 2013 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER INC.
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Include
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DI2 - Off Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-eluting balloon in peripheral intervention for the superficial femoral artery: The DEBATE-SFA randomized trial (Drug Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery) ###Abstract: Objectives This study sought to compare paclitaxel-eluting balloon (PEB) with conventional percutaneous transluminal angioplasty (PTA), followed by systematic implantation of a self-expanding nitinol bare-metal stent (BMS) in patients at risk for restenosis. Background PTA is an effective strategy for treating atherosclerosis of the femoropopliteal axis (FPA). Whereas PEB have shown advantage over uncoated balloons in the treatment of simple lesions, it is unknown whether these results are applicable to complex degrees of FPA atheroma. Methods A total of 104 patients (110 FPA lesions in 110 limbs) were randomly assigned to either PEB + BMS or PTA + BMS. The primary endpoint was 12-month binary restenosis. Secondary endpoints were freedom from target lesion revascularization and major amputation. Post hoc subanalyses were performed for the comparison of long (≥100 mm) versus short lesions and true lumen versus subintimal approach. Results Mean lesion length was 94 ± 60 versus 96 ± 69 mm in the PEB + BMS and PTA + BMS groups (p = 0.8), respectively. The primary endpoint occurred in 9 (17%) versus 26 (47.3%) of lesions in the PEB + BMS and PTA + BMS groups (p = 0.008), respectively. A near-significant (p = 0.07) 1-year freedom from target lesion revascularization advantage was observed in the PEB + BMS group. No major amputation occurred. No significant difference was observed according to lesion characteristics or technical approach. Conclusions Pre-dilation with PEB angioplasty prior to BMS implantation, as compared to PTA + BMS in complex FPA lesions, reduces restenosis and target lesion revascularization at 12-month follow-up. Restenosis reduction is maintained irrespective of lesion length and recanalization technique. (Drug Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery [DEBATE-SFA]; NCT01556542). © 2013 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER INC. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-eluting balloon in peripheral intervention for the superficial femoral artery: The DEBATE-SFA randomized trial (Drug Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery) ###Abstract: Objectives This study sought to compare paclitaxel-eluting balloon (PEB) with conventional percutaneous transluminal angioplasty (PTA), followed by systematic implantation of a self-expanding nitinol bare-metal stent (BMS) in patients at risk for restenosis. Background PTA is an effective strategy for treating atherosclerosis of the femoropopliteal axis (FPA). Whereas PEB have shown advantage over uncoated balloons in the treatment of simple lesions, it is unknown whether these results are applicable to complex degrees of FPA atheroma. Methods A total of 104 patients (110 FPA lesions in 110 limbs) were randomly assigned to either PEB + BMS or PTA + BMS. The primary endpoint was 12-month binary restenosis. Secondary endpoints were freedom from target lesion revascularization and major amputation. Post hoc subanalyses were performed for the comparison of long (≥100 mm) versus short lesions and true lumen versus subintimal approach. Results Mean lesion length was 94 ± 60 versus 96 ± 69 mm in the PEB + BMS and PTA + BMS groups (p = 0.8), respectively. The primary endpoint occurred in 9 (17%) versus 26 (47.3%) of lesions in the PEB + BMS and PTA + BMS groups (p = 0.008), respectively. A near-significant (p = 0.07) 1-year freedom from target lesion revascularization advantage was observed in the PEB + BMS group. No major amputation occurred. No significant difference was observed according to lesion characteristics or technical approach. Conclusions Pre-dilation with PEB angioplasty prior to BMS implantation, as compared to PTA + BMS in complex FPA lesions, reduces restenosis and target lesion revascularization at 12-month follow-up. Restenosis reduction is maintained irrespective of lesion length and recanalization technique. (Drug Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery [DEBATE-SFA]; NCT01556542). © 2013 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER INC. [/INST] Include </s>
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Long 2019
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Use and 1-year outcomes with conventional and drug-coated balloon angioplasty in patients with lower extremity peripheral artery disease
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Background: With the growing use of drug-coated balloons for the treatment of peripheral artery disease, information regarding the safety and effectiveness of drug-coated balloons in current practice is needed. We examined patient, physician, and procedural characteristics as well as cardiovascular and limb events in patients who underwent peripheral vascular intervention with drug-coated balloons. Methods: This is a retrospective cohort analysis utilizing Medicare data for 100% of fee-for-service beneficiaries from 2015 to 2016 who had a claim for femoropopliteal intervention. The use of drug-coated balloons was identified via specific transitional pass-through codes. All-cause mortality, all-cause hospitalization, repeat femoropopliteal intervention, and major lower extremity amputation at 1 year were the clinical outcomes of interest. Results: In total, 83,225 patients underwent femoropopliteal intervention, and drug-coated balloons were utilized in 29% of all procedures. Patients treated with drug-coated balloons had a lower cumulative incidence of all-cause hospitalization, all-cause mortality, and major lower extremity amputation, but were more likely to undergo repeat femoropopliteal intervention when compared with patients treated with conventional balloon angioplasty. After adjustment for measured confounders, patients treated with drug-coated balloons had lower rates of hospitalization (HR 0.91 (0.88, 0.93), P < .001), all-cause mortality (HR 0.89 [0.84, 0.94], P < .001), and major amputation (HR 0.93 [0.88, 0.99], P = .017). Conclusions: Patients who underwent femoropopliteal intervention with drug-coated balloons had lower observed rates of all-cause mortality, all-cause hospitalization, and major amputation at 1 year. Interestingly, there was not a reduction in rates of repeat revascularization, and further work is required to understand this finding. Nevertheless, the use of drug-coated balloons appears to be safe in this large study of contemporary patients in the United States.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Use and 1-year outcomes with conventional and drug-coated balloon angioplasty in patients with lower extremity peripheral artery disease ###Abstract: Background: With the growing use of drug-coated balloons for the treatment of peripheral artery disease, information regarding the safety and effectiveness of drug-coated balloons in current practice is needed. We examined patient, physician, and procedural characteristics as well as cardiovascular and limb events in patients who underwent peripheral vascular intervention with drug-coated balloons. Methods: This is a retrospective cohort analysis utilizing Medicare data for 100% of fee-for-service beneficiaries from 2015 to 2016 who had a claim for femoropopliteal intervention. The use of drug-coated balloons was identified via specific transitional pass-through codes. All-cause mortality, all-cause hospitalization, repeat femoropopliteal intervention, and major lower extremity amputation at 1 year were the clinical outcomes of interest. Results: In total, 83,225 patients underwent femoropopliteal intervention, and drug-coated balloons were utilized in 29% of all procedures. Patients treated with drug-coated balloons had a lower cumulative incidence of all-cause hospitalization, all-cause mortality, and major lower extremity amputation, but were more likely to undergo repeat femoropopliteal intervention when compared with patients treated with conventional balloon angioplasty. After adjustment for measured confounders, patients treated with drug-coated balloons had lower rates of hospitalization (HR 0.91 (0.88, 0.93), P < .001), all-cause mortality (HR 0.89 [0.84, 0.94], P < .001), and major amputation (HR 0.93 [0.88, 0.99], P = .017). Conclusions: Patients who underwent femoropopliteal intervention with drug-coated balloons had lower observed rates of all-cause mortality, all-cause hospitalization, and major amputation at 1 year. Interestingly, there was not a reduction in rates of repeat revascularization, and further work is required to understand this finding. Nevertheless, the use of drug-coated balloons appears to be safe in this large study of contemporary patients in the United States. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Use and 1-year outcomes with conventional and drug-coated balloon angioplasty in patients with lower extremity peripheral artery disease ###Abstract: Background: With the growing use of drug-coated balloons for the treatment of peripheral artery disease, information regarding the safety and effectiveness of drug-coated balloons in current practice is needed. We examined patient, physician, and procedural characteristics as well as cardiovascular and limb events in patients who underwent peripheral vascular intervention with drug-coated balloons. Methods: This is a retrospective cohort analysis utilizing Medicare data for 100% of fee-for-service beneficiaries from 2015 to 2016 who had a claim for femoropopliteal intervention. The use of drug-coated balloons was identified via specific transitional pass-through codes. All-cause mortality, all-cause hospitalization, repeat femoropopliteal intervention, and major lower extremity amputation at 1 year were the clinical outcomes of interest. Results: In total, 83,225 patients underwent femoropopliteal intervention, and drug-coated balloons were utilized in 29% of all procedures. Patients treated with drug-coated balloons had a lower cumulative incidence of all-cause hospitalization, all-cause mortality, and major lower extremity amputation, but were more likely to undergo repeat femoropopliteal intervention when compared with patients treated with conventional balloon angioplasty. After adjustment for measured confounders, patients treated with drug-coated balloons had lower rates of hospitalization (HR 0.91 (0.88, 0.93), P < .001), all-cause mortality (HR 0.89 [0.84, 0.94], P < .001), and major amputation (HR 0.93 [0.88, 0.99], P = .017). Conclusions: Patients who underwent femoropopliteal intervention with drug-coated balloons had lower observed rates of all-cause mortality, all-cause hospitalization, and major amputation at 1 year. Interestingly, there was not a reduction in rates of repeat revascularization, and further work is required to understand this finding. Nevertheless, the use of drug-coated balloons appears to be safe in this large study of contemporary patients in the United States. [/INST] Include </s>
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Lookstein 2020
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Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas
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BACKGROUND Standard percutaneous transluminal angioplasty is the current recommended treatment for dysfunctional hemodialysis fistulas, yet long-term outcomes of this treatment are poor. Drug-coated balloons delivering the antirestenotic agent paclitaxel may improve outcomes. METHODS In this prospective, single-blinded, 1:1 randomized trial, we enrolled 330 participants at 29 international sites. Patients with new or restenotic lesions in native upper-extremity arteriovenous fistulas were eligible for participation. After successful high-pressure percutaneous transluminal angioplasty, participants were randomly assigned to receive treatment with a drug-coated balloon or a standard balloon. The primary effectiveness end point was target-lesion primary patency, defined as freedom from clinically driven target-lesion revascularization or accesscircuit thrombosis during the 6 months after the index procedure. The primary safety end point, serious adverse events involving the arteriovenous access circuit within 30 days, was assessed in a noninferiority analysis (margin of noninferiority, 7.5 percentage points). The primary analyses included all participants with available end-point data. Additional sensitivity analyses were performed to assess the effect of missing data. RESULTS A total of 330 participants underwent randomization; 170 were assigned to receive treatment with a drug-coated balloon, and 160 were assigned to receive treatment with a standard balloon. During the 6 months after the index procedure, targetlesion primary patency was maintained more often in participants who had been treated with a drug-coated balloon than in those who had been treated with a standard balloon (82.2% [125 of 152] vs. 59.5% [88 of 148]; difference in risk, 22.8 percentage points; 95% confidence interval [CI], 12.8 to 32.8; P 0.001). Drugcoated balloons were noninferior to standard balloons with respect to the primary safety end point (4.2% [7 of 166] and 4.4% [7 of 158], respectively; difference in risk, −0.2 percentage points; 95% CI, −5.5 to 5.0; P = 0.002 for noninferiority). Sensitivity analyses confirmed the results of the primary analyses. CONCLUSIONS Drug-coated balloon angioplasty was superior to standard angioplasty for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulas during the 6 months after the procedure and was noninferior with respect to access circuit–related serious adverse events within 30 days. (Funded by Medtronic; IN.PACT AV Access Study ClinicalTrials.gov number, NCT03041467.).
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas ###Abstract: BACKGROUND Standard percutaneous transluminal angioplasty is the current recommended treatment for dysfunctional hemodialysis fistulas, yet long-term outcomes of this treatment are poor. Drug-coated balloons delivering the antirestenotic agent paclitaxel may improve outcomes. METHODS In this prospective, single-blinded, 1:1 randomized trial, we enrolled 330 participants at 29 international sites. Patients with new or restenotic lesions in native upper-extremity arteriovenous fistulas were eligible for participation. After successful high-pressure percutaneous transluminal angioplasty, participants were randomly assigned to receive treatment with a drug-coated balloon or a standard balloon. The primary effectiveness end point was target-lesion primary patency, defined as freedom from clinically driven target-lesion revascularization or accesscircuit thrombosis during the 6 months after the index procedure. The primary safety end point, serious adverse events involving the arteriovenous access circuit within 30 days, was assessed in a noninferiority analysis (margin of noninferiority, 7.5 percentage points). The primary analyses included all participants with available end-point data. Additional sensitivity analyses were performed to assess the effect of missing data. RESULTS A total of 330 participants underwent randomization; 170 were assigned to receive treatment with a drug-coated balloon, and 160 were assigned to receive treatment with a standard balloon. During the 6 months after the index procedure, targetlesion primary patency was maintained more often in participants who had been treated with a drug-coated balloon than in those who had been treated with a standard balloon (82.2% [125 of 152] vs. 59.5% [88 of 148]; difference in risk, 22.8 percentage points; 95% confidence interval [CI], 12.8 to 32.8; P 0.001). Drugcoated balloons were noninferior to standard balloons with respect to the primary safety end point (4.2% [7 of 166] and 4.4% [7 of 158], respectively; difference in risk, −0.2 percentage points; 95% CI, −5.5 to 5.0; P = 0.002 for noninferiority). Sensitivity analyses confirmed the results of the primary analyses. CONCLUSIONS Drug-coated balloon angioplasty was superior to standard angioplasty for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulas during the 6 months after the procedure and was noninferior with respect to access circuit–related serious adverse events within 30 days. (Funded by Medtronic; IN.PACT AV Access Study ClinicalTrials.gov number, NCT03041467.). [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas ###Abstract: BACKGROUND Standard percutaneous transluminal angioplasty is the current recommended treatment for dysfunctional hemodialysis fistulas, yet long-term outcomes of this treatment are poor. Drug-coated balloons delivering the antirestenotic agent paclitaxel may improve outcomes. METHODS In this prospective, single-blinded, 1:1 randomized trial, we enrolled 330 participants at 29 international sites. Patients with new or restenotic lesions in native upper-extremity arteriovenous fistulas were eligible for participation. After successful high-pressure percutaneous transluminal angioplasty, participants were randomly assigned to receive treatment with a drug-coated balloon or a standard balloon. The primary effectiveness end point was target-lesion primary patency, defined as freedom from clinically driven target-lesion revascularization or accesscircuit thrombosis during the 6 months after the index procedure. The primary safety end point, serious adverse events involving the arteriovenous access circuit within 30 days, was assessed in a noninferiority analysis (margin of noninferiority, 7.5 percentage points). The primary analyses included all participants with available end-point data. Additional sensitivity analyses were performed to assess the effect of missing data. RESULTS A total of 330 participants underwent randomization; 170 were assigned to receive treatment with a drug-coated balloon, and 160 were assigned to receive treatment with a standard balloon. During the 6 months after the index procedure, targetlesion primary patency was maintained more often in participants who had been treated with a drug-coated balloon than in those who had been treated with a standard balloon (82.2% [125 of 152] vs. 59.5% [88 of 148]; difference in risk, 22.8 percentage points; 95% confidence interval [CI], 12.8 to 32.8; P 0.001). Drugcoated balloons were noninferior to standard balloons with respect to the primary safety end point (4.2% [7 of 166] and 4.4% [7 of 158], respectively; difference in risk, −0.2 percentage points; 95% CI, −5.5 to 5.0; P = 0.002 for noninferiority). Sensitivity analyses confirmed the results of the primary analyses. CONCLUSIONS Drug-coated balloon angioplasty was superior to standard angioplasty for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulas during the 6 months after the procedure and was noninferior with respect to access circuit–related serious adverse events within 30 days. (Funded by Medtronic; IN.PACT AV Access Study ClinicalTrials.gov number, NCT03041467.). [/INST] Include </s>
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Lučev 2018
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Endovascular Treatment of Haemodialysis Arteriovenous Fistula with Drug-Coated Balloon Angioplasty: A Single-Centre Study
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Purpose: To evaluate the effect of percutaneous transluminal angioplasty (PTA) on haemodialysis fistulas utilising drug-coated balloons with plain balloon vessel preparation (DCB). Materials and Methods: In the study group, 31 patients (16 men; mean age 62.8 ± 17.2 years) with failing arteriovenous fistulas were treated, with DCB, and compared with a control group (31 patients; 15 men; mean age 67.0 ± 8.44 years), in which only plain balloon PTA was performed. All stenoses were dilated with regular PTA balloons. After achieving haemodynamic success (< 30% residual stenosis), drug-coated balloons were used for drug administration in the study group. The follow-up intervals were 6, 12 and 24 months. Target lesion primary patency, primary assisted patency and secondary patency were compared. The statistical significance was set at 0.05. Results: Target lesion primary patency was compared in both groups and was significantly higher in the study group (DCB) at 6 months (90.3 vs. 61.3%; p = 0.016), 12 months (77.4 vs. 29%; p = 0.0004) as well as 24 months (45.2 vs. 16.1%; p = 0.026). Kaplan–Meier survival curves also showed a significant difference for target lesion primary patency (534.2 vs. 315.7 days; p = 0.0004). There were no significant differences in target lesion primary assisted patency and in secondary patency. However, only 38.7% of patients in the study group were treated twice or more versus 80.6% in the control group (p = 0.002). Conclusion: DCB increases target lesion primary patency during the first 24 months and decreases the rate of reinterventions.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Endovascular Treatment of Haemodialysis Arteriovenous Fistula with Drug-Coated Balloon Angioplasty: A Single-Centre Study ###Abstract: Purpose: To evaluate the effect of percutaneous transluminal angioplasty (PTA) on haemodialysis fistulas utilising drug-coated balloons with plain balloon vessel preparation (DCB). Materials and Methods: In the study group, 31 patients (16 men; mean age 62.8 ± 17.2 years) with failing arteriovenous fistulas were treated, with DCB, and compared with a control group (31 patients; 15 men; mean age 67.0 ± 8.44 years), in which only plain balloon PTA was performed. All stenoses were dilated with regular PTA balloons. After achieving haemodynamic success (< 30% residual stenosis), drug-coated balloons were used for drug administration in the study group. The follow-up intervals were 6, 12 and 24 months. Target lesion primary patency, primary assisted patency and secondary patency were compared. The statistical significance was set at 0.05. Results: Target lesion primary patency was compared in both groups and was significantly higher in the study group (DCB) at 6 months (90.3 vs. 61.3%; p = 0.016), 12 months (77.4 vs. 29%; p = 0.0004) as well as 24 months (45.2 vs. 16.1%; p = 0.026). Kaplan–Meier survival curves also showed a significant difference for target lesion primary patency (534.2 vs. 315.7 days; p = 0.0004). There were no significant differences in target lesion primary assisted patency and in secondary patency. However, only 38.7% of patients in the study group were treated twice or more versus 80.6% in the control group (p = 0.002). Conclusion: DCB increases target lesion primary patency during the first 24 months and decreases the rate of reinterventions. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Endovascular Treatment of Haemodialysis Arteriovenous Fistula with Drug-Coated Balloon Angioplasty: A Single-Centre Study ###Abstract: Purpose: To evaluate the effect of percutaneous transluminal angioplasty (PTA) on haemodialysis fistulas utilising drug-coated balloons with plain balloon vessel preparation (DCB). Materials and Methods: In the study group, 31 patients (16 men; mean age 62.8 ± 17.2 years) with failing arteriovenous fistulas were treated, with DCB, and compared with a control group (31 patients; 15 men; mean age 67.0 ± 8.44 years), in which only plain balloon PTA was performed. All stenoses were dilated with regular PTA balloons. After achieving haemodynamic success (< 30% residual stenosis), drug-coated balloons were used for drug administration in the study group. The follow-up intervals were 6, 12 and 24 months. Target lesion primary patency, primary assisted patency and secondary patency were compared. The statistical significance was set at 0.05. Results: Target lesion primary patency was compared in both groups and was significantly higher in the study group (DCB) at 6 months (90.3 vs. 61.3%; p = 0.016), 12 months (77.4 vs. 29%; p = 0.0004) as well as 24 months (45.2 vs. 16.1%; p = 0.026). Kaplan–Meier survival curves also showed a significant difference for target lesion primary patency (534.2 vs. 315.7 days; p = 0.0004). There were no significant differences in target lesion primary assisted patency and in secondary patency. However, only 38.7% of patients in the study group were treated twice or more versus 80.6% in the control group (p = 0.002). Conclusion: DCB increases target lesion primary patency during the first 24 months and decreases the rate of reinterventions. [/INST] Include </s>
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Maleux 2018
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Multicenter, Randomized Trial of Conventional Balloon Angioplasty versus Paclitaxel-Coated Balloon Angioplasty for the Treatment of Dysfunctioning Autologous Dialysis Fistulae
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Purpose: To investigate the potential added value of paclitaxel-coated balloon (PCB) angioplasty to reduce fistula dysfunction related to recurrent stenoses in patients undergoing hemodialysis. Materials and Methods: A prospective, randomized study was conducted in 3 dialysis referral centers. From January 2013 to October 2015, 64 patients (22 female, 42 male) with dysfunctional autologous dialysis fistulae were randomized to undergo conventional percutaneous balloon angioplasty (n = 31) or PCB angioplasty (n = 33). Procedural and postprocedural data were assessed. Primary patency of the fistula was evaluated at 3, 6, and 12 months following the procedure. Statistical analysis was based on the Fisher exact test and independent t test. Results: There were no procedural or postprocedural complications. After 3, 6, and 12 months of follow-up, primary patency rates after PCB angioplasty and percutaneous transluminal angioplasty (PTA) were 88% and 80% (P =.43), 67% and 65% (P =.76), and 42% and 39% (P =.95), respectively. Conclusions: Although primary patency rates after PCB angioplasty in autologous dialysis fistulae at 3, 6, and 12 months of follow-up are slightly better than those after PTA, the difference is not statistically significant.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Multicenter, Randomized Trial of Conventional Balloon Angioplasty versus Paclitaxel-Coated Balloon Angioplasty for the Treatment of Dysfunctioning Autologous Dialysis Fistulae ###Abstract: Purpose: To investigate the potential added value of paclitaxel-coated balloon (PCB) angioplasty to reduce fistula dysfunction related to recurrent stenoses in patients undergoing hemodialysis. Materials and Methods: A prospective, randomized study was conducted in 3 dialysis referral centers. From January 2013 to October 2015, 64 patients (22 female, 42 male) with dysfunctional autologous dialysis fistulae were randomized to undergo conventional percutaneous balloon angioplasty (n = 31) or PCB angioplasty (n = 33). Procedural and postprocedural data were assessed. Primary patency of the fistula was evaluated at 3, 6, and 12 months following the procedure. Statistical analysis was based on the Fisher exact test and independent t test. Results: There were no procedural or postprocedural complications. After 3, 6, and 12 months of follow-up, primary patency rates after PCB angioplasty and percutaneous transluminal angioplasty (PTA) were 88% and 80% (P =.43), 67% and 65% (P =.76), and 42% and 39% (P =.95), respectively. Conclusions: Although primary patency rates after PCB angioplasty in autologous dialysis fistulae at 3, 6, and 12 months of follow-up are slightly better than those after PTA, the difference is not statistically significant. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Multicenter, Randomized Trial of Conventional Balloon Angioplasty versus Paclitaxel-Coated Balloon Angioplasty for the Treatment of Dysfunctioning Autologous Dialysis Fistulae ###Abstract: Purpose: To investigate the potential added value of paclitaxel-coated balloon (PCB) angioplasty to reduce fistula dysfunction related to recurrent stenoses in patients undergoing hemodialysis. Materials and Methods: A prospective, randomized study was conducted in 3 dialysis referral centers. From January 2013 to October 2015, 64 patients (22 female, 42 male) with dysfunctional autologous dialysis fistulae were randomized to undergo conventional percutaneous balloon angioplasty (n = 31) or PCB angioplasty (n = 33). Procedural and postprocedural data were assessed. Primary patency of the fistula was evaluated at 3, 6, and 12 months following the procedure. Statistical analysis was based on the Fisher exact test and independent t test. Results: There were no procedural or postprocedural complications. After 3, 6, and 12 months of follow-up, primary patency rates after PCB angioplasty and percutaneous transluminal angioplasty (PTA) were 88% and 80% (P =.43), 67% and 65% (P =.76), and 42% and 39% (P =.95), respectively. Conclusions: Although primary patency rates after PCB angioplasty in autologous dialysis fistulae at 3, 6, and 12 months of follow-up are slightly better than those after PTA, the difference is not statistically significant. [/INST] Include </s>
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Micari 2012
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Clinical Evaluation of a Paclitaxel-Eluting Balloon for Treatment of Femoropopliteal Arterial Disease: 12-Month Results From a Multicenter Italian Registry
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Objectives This study evaluated the use of a paclitaxel-eluting balloon (PEB) for treatment of femoropopliteal arterial disease. Background Conventional balloon angioplasty and stenting in this setting is associated with high restenosis rates within 12 months. Recent data suggest that PEB use may reduce restenosis. Twelve-month outcomes following PEB use with provisional stenting are described. Methods
This prospective registry enrolled patients (Rutherford class 2 to 4) with reference vessel diameter of 3 to 7 mm and lesion/occlusion length ≤15 cm. Endpoints included primary patency rate, target lesion revascularization, and changes in Rutherford class and ankle-brachial index. Walking capacity, absolute claudication distance, and quality of life were also assessed. Results The registry enrolled 105 patients. Baseline ankle-brachial index was 0.56 ± 0.15. Baseline Rutherford classification was class 2 or 3 for most patients (91.5%). Most lesions were located in the superficial femoral artery (77.1%). Mean lesion length was 76.3 ± 38.3 mm; 29.8% of lesions were total occlusions. The device was successfully used in all patients and only 12.3% of lesions required stenting. At 12-month follow-up, 92 of 105 patients (87.6%) were evaluable; the primary patency rate was 83.7%; the target lesion revascularization rate was 7.6%; 85.6% of patients were Rutherford class 0 or 1; and mean ankle-brachial index was 0.86 ± 0.15. Quality of life and absolute claudication distance showed significant improvement from baseline to 12-month follow-up. Conclusions PEB treatment of femoropopliteal arterial disease resulted in consistent clinical improvement across multiple endpoints with a low rate of stenting and target lesion revascularization.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Clinical Evaluation of a Paclitaxel-Eluting Balloon for Treatment of Femoropopliteal Arterial Disease: 12-Month Results From a Multicenter Italian Registry ###Abstract: Objectives This study evaluated the use of a paclitaxel-eluting balloon (PEB) for treatment of femoropopliteal arterial disease. Background Conventional balloon angioplasty and stenting in this setting is associated with high restenosis rates within 12 months. Recent data suggest that PEB use may reduce restenosis. Twelve-month outcomes following PEB use with provisional stenting are described. Methods
This prospective registry enrolled patients (Rutherford class 2 to 4) with reference vessel diameter of 3 to 7 mm and lesion/occlusion length ≤15 cm. Endpoints included primary patency rate, target lesion revascularization, and changes in Rutherford class and ankle-brachial index. Walking capacity, absolute claudication distance, and quality of life were also assessed. Results The registry enrolled 105 patients. Baseline ankle-brachial index was 0.56 ± 0.15. Baseline Rutherford classification was class 2 or 3 for most patients (91.5%). Most lesions were located in the superficial femoral artery (77.1%). Mean lesion length was 76.3 ± 38.3 mm; 29.8% of lesions were total occlusions. The device was successfully used in all patients and only 12.3% of lesions required stenting. At 12-month follow-up, 92 of 105 patients (87.6%) were evaluable; the primary patency rate was 83.7%; the target lesion revascularization rate was 7.6%; 85.6% of patients were Rutherford class 0 or 1; and mean ankle-brachial index was 0.86 ± 0.15. Quality of life and absolute claudication distance showed significant improvement from baseline to 12-month follow-up. Conclusions PEB treatment of femoropopliteal arterial disease resulted in consistent clinical improvement across multiple endpoints with a low rate of stenting and target lesion revascularization. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Clinical Evaluation of a Paclitaxel-Eluting Balloon for Treatment of Femoropopliteal Arterial Disease: 12-Month Results From a Multicenter Italian Registry ###Abstract: Objectives This study evaluated the use of a paclitaxel-eluting balloon (PEB) for treatment of femoropopliteal arterial disease. Background Conventional balloon angioplasty and stenting in this setting is associated with high restenosis rates within 12 months. Recent data suggest that PEB use may reduce restenosis. Twelve-month outcomes following PEB use with provisional stenting are described. Methods
This prospective registry enrolled patients (Rutherford class 2 to 4) with reference vessel diameter of 3 to 7 mm and lesion/occlusion length ≤15 cm. Endpoints included primary patency rate, target lesion revascularization, and changes in Rutherford class and ankle-brachial index. Walking capacity, absolute claudication distance, and quality of life were also assessed. Results The registry enrolled 105 patients. Baseline ankle-brachial index was 0.56 ± 0.15. Baseline Rutherford classification was class 2 or 3 for most patients (91.5%). Most lesions were located in the superficial femoral artery (77.1%). Mean lesion length was 76.3 ± 38.3 mm; 29.8% of lesions were total occlusions. The device was successfully used in all patients and only 12.3% of lesions required stenting. At 12-month follow-up, 92 of 105 patients (87.6%) were evaluable; the primary patency rate was 83.7%; the target lesion revascularization rate was 7.6%; 85.6% of patients were Rutherford class 0 or 1; and mean ankle-brachial index was 0.86 ± 0.15. Quality of life and absolute claudication distance showed significant improvement from baseline to 12-month follow-up. Conclusions PEB treatment of femoropopliteal arterial disease resulted in consistent clinical improvement across multiple endpoints with a low rate of stenting and target lesion revascularization. [/INST] Include </s>
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Micari 2013
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2-year results of paclitaxel-eluting balloons for femoropopliteal artery disease
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Objectives This study aimed to appraise 2-year outcomes after percutaneous treatment of femoropopliteal artery disease with paclitaxel-eluting balloons. Background Percutaneous transluminal angioplasty with paclitaxel-eluting balloons for femoropopliteal artery disease has provided favorable 1-year results. Methods Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions≤15 mm long and with 3- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter registry. Endpoints of interest included primary patency, major adverse events (the composite of death, amputation, or target lesion revascularization), changes in Rutherford class, anklebrachial index, absolute claudication distance, and quality of life after≥24 months. Results A total of 105 patients (114 lesions) treated with paclitaxel-eluting balloons and provisional stenting were enrolled, and final procedural success was obtained in all. Follow-up after 27±3 months was obtained in 98 (93.3%) patients, showing that primary patency was maintained in 71 (72.4%), and major adverse events had occurred in 17 (17.5%), with persistently significant benefits in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life (all p<0.001). Secondary patency rate was achieved in 89 cases (84.7%). Conclusions PEBs are associated with favorable functional and clinical outcomes at 2 years in patients with femoropopliteal artery disease requiring percutaneous revascularization. © 2013 by the American College of Cardiology Foundation.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: 2-year results of paclitaxel-eluting balloons for femoropopliteal artery disease ###Abstract: Objectives This study aimed to appraise 2-year outcomes after percutaneous treatment of femoropopliteal artery disease with paclitaxel-eluting balloons. Background Percutaneous transluminal angioplasty with paclitaxel-eluting balloons for femoropopliteal artery disease has provided favorable 1-year results. Methods Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions≤15 mm long and with 3- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter registry. Endpoints of interest included primary patency, major adverse events (the composite of death, amputation, or target lesion revascularization), changes in Rutherford class, anklebrachial index, absolute claudication distance, and quality of life after≥24 months. Results A total of 105 patients (114 lesions) treated with paclitaxel-eluting balloons and provisional stenting were enrolled, and final procedural success was obtained in all. Follow-up after 27±3 months was obtained in 98 (93.3%) patients, showing that primary patency was maintained in 71 (72.4%), and major adverse events had occurred in 17 (17.5%), with persistently significant benefits in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life (all p<0.001). Secondary patency rate was achieved in 89 cases (84.7%). Conclusions PEBs are associated with favorable functional and clinical outcomes at 2 years in patients with femoropopliteal artery disease requiring percutaneous revascularization. © 2013 by the American College of Cardiology Foundation. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: 2-year results of paclitaxel-eluting balloons for femoropopliteal artery disease ###Abstract: Objectives This study aimed to appraise 2-year outcomes after percutaneous treatment of femoropopliteal artery disease with paclitaxel-eluting balloons. Background Percutaneous transluminal angioplasty with paclitaxel-eluting balloons for femoropopliteal artery disease has provided favorable 1-year results. Methods Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions≤15 mm long and with 3- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter registry. Endpoints of interest included primary patency, major adverse events (the composite of death, amputation, or target lesion revascularization), changes in Rutherford class, anklebrachial index, absolute claudication distance, and quality of life after≥24 months. Results A total of 105 patients (114 lesions) treated with paclitaxel-eluting balloons and provisional stenting were enrolled, and final procedural success was obtained in all. Follow-up after 27±3 months was obtained in 98 (93.3%) patients, showing that primary patency was maintained in 71 (72.4%), and major adverse events had occurred in 17 (17.5%), with persistently significant benefits in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life (all p<0.001). Secondary patency rate was achieved in 89 cases (84.7%). Conclusions PEBs are associated with favorable functional and clinical outcomes at 2 years in patients with femoropopliteal artery disease requiring percutaneous revascularization. © 2013 by the American College of Cardiology Foundation. [/INST] Include </s>
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Micari 2016
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1-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease Evidence from the SFA-Long Study
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Objectives: The aim of this study was to appraise 1-year outcomes after percutaneous treatment of long femoropopliteal artery disease using paclitaxel-coated balloons. Background: Percutaneous transluminal angioplasty with paclitaxel-coated balloons for TransAtlantic Inter-Society Consensus types A and B femoropopliteal artery disease has provided favorable results. Methods: Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long and with 4- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency at 12 months. Secondary endpoints included major adverse events (the composite of death, major target limb amputation, thrombosis at the target lesion site, or clinically driven non-target lesion target vessel revascularization), changes in Rutherford class, ankle-brachial index, and quality of life up to 24 months post-procedure. Results: A total of 105 patients (mean age 68 ± 9 years, 81.9% men) treated with paclitaxel-coated balloons and provisional stenting were enrolled, and final procedural success was obtained in all. The mean treated lesion length was 251 ± 71 mm, including 63.4% moderate to severely calcified lesions and 49.5% total occlusions. The bailout stent rate was 10.9%. Follow-up after 12 months was obtained in 101 patients (96.2%), showing that primary patency was maintained in 84 (83.2%), and major adverse events had occurred in 7 (6.2%), with persistently significant clinical benefits in Rutherford class. Conclusions: Paclitaxel-coated balloons are associated with favorable functional and clinical outcomes at 1 year in patients with long femoropopliteal artery disease requiring percutaneous revascularization. (Drug Eluting Balloon [DEB] and Long Lesions of Superficial Femoral Artery [SFA] Ischemic Vascular Disease [DEB-SFA-LONG]; NCT01658540).
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: 1-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease Evidence from the SFA-Long Study ###Abstract: Objectives: The aim of this study was to appraise 1-year outcomes after percutaneous treatment of long femoropopliteal artery disease using paclitaxel-coated balloons. Background: Percutaneous transluminal angioplasty with paclitaxel-coated balloons for TransAtlantic Inter-Society Consensus types A and B femoropopliteal artery disease has provided favorable results. Methods: Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long and with 4- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency at 12 months. Secondary endpoints included major adverse events (the composite of death, major target limb amputation, thrombosis at the target lesion site, or clinically driven non-target lesion target vessel revascularization), changes in Rutherford class, ankle-brachial index, and quality of life up to 24 months post-procedure. Results: A total of 105 patients (mean age 68 ± 9 years, 81.9% men) treated with paclitaxel-coated balloons and provisional stenting were enrolled, and final procedural success was obtained in all. The mean treated lesion length was 251 ± 71 mm, including 63.4% moderate to severely calcified lesions and 49.5% total occlusions. The bailout stent rate was 10.9%. Follow-up after 12 months was obtained in 101 patients (96.2%), showing that primary patency was maintained in 84 (83.2%), and major adverse events had occurred in 7 (6.2%), with persistently significant clinical benefits in Rutherford class. Conclusions: Paclitaxel-coated balloons are associated with favorable functional and clinical outcomes at 1 year in patients with long femoropopliteal artery disease requiring percutaneous revascularization. (Drug Eluting Balloon [DEB] and Long Lesions of Superficial Femoral Artery [SFA] Ischemic Vascular Disease [DEB-SFA-LONG]; NCT01658540). [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: 1-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease Evidence from the SFA-Long Study ###Abstract: Objectives: The aim of this study was to appraise 1-year outcomes after percutaneous treatment of long femoropopliteal artery disease using paclitaxel-coated balloons. Background: Percutaneous transluminal angioplasty with paclitaxel-coated balloons for TransAtlantic Inter-Society Consensus types A and B femoropopliteal artery disease has provided favorable results. Methods: Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long and with 4- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency at 12 months. Secondary endpoints included major adverse events (the composite of death, major target limb amputation, thrombosis at the target lesion site, or clinically driven non-target lesion target vessel revascularization), changes in Rutherford class, ankle-brachial index, and quality of life up to 24 months post-procedure. Results: A total of 105 patients (mean age 68 ± 9 years, 81.9% men) treated with paclitaxel-coated balloons and provisional stenting were enrolled, and final procedural success was obtained in all. The mean treated lesion length was 251 ± 71 mm, including 63.4% moderate to severely calcified lesions and 49.5% total occlusions. The bailout stent rate was 10.9%. Follow-up after 12 months was obtained in 101 patients (96.2%), showing that primary patency was maintained in 84 (83.2%), and major adverse events had occurred in 7 (6.2%), with persistently significant clinical benefits in Rutherford class. Conclusions: Paclitaxel-coated balloons are associated with favorable functional and clinical outcomes at 1 year in patients with long femoropopliteal artery disease requiring percutaneous revascularization. (Drug Eluting Balloon [DEB] and Long Lesions of Superficial Femoral Artery [SFA] Ischemic Vascular Disease [DEB-SFA-LONG]; NCT01658540). [/INST] Include </s>
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Micari 2017
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2-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease: Evidence From the SFA-Long Study
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Objectives The aim of this study was to appraise 2-year outcomes after percutaneous transluminal angioplasty of long femoropopliteal artery disease using paclitaxel-coated balloons (PCBs). Background Percutaneous transluminal angioplasty with PCBs for TransAtlantic Inter-Society Consensus types C and D femoropopliteal artery disease has provided favorable results ≤12 months but no prospective studies performed longer term follow-up assessment. Methods Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency (i.e., freedom from the combined endpoint of clinically driven target lesion revascularization and >50% restenosis in the treated lesion as appraised by a duplex ultrasound peak systolic velocity ratio of >2.4) at 24 months. Secondary endpoints included major adverse events (the composite of death, target limb amputation, thrombosis at the target lesion, or clinically driven nontarget lesion revascularization), changes in Rutherford class, and quality of life ≤24 months post-procedure. Results A total of 105 patients (age 68 ± 9 years; 81.9% men) successfully treated with PCBs were included (treated lesion length was 251 ± 71 mm; 49.5% total occlusions). The 24-month follow-up data were available in 98 patients; they showed a primary patency rate of 70.4%, with major adverse events occurred in 10 patients (10.2%, 5 non–procedure-related deaths) and persistently significant clinical benefits in Rutherford class (51% of asymptomatic patients at 24 months). Conclusions PCBs benefits on primary patency and target vessel revascularization satisfactorily extend over 24 months in patients undergoing percutaneous transluminal angioplasty for symptomatic femoropopliteal disease.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: 2-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease: Evidence From the SFA-Long Study ###Abstract: Objectives The aim of this study was to appraise 2-year outcomes after percutaneous transluminal angioplasty of long femoropopliteal artery disease using paclitaxel-coated balloons (PCBs). Background Percutaneous transluminal angioplasty with PCBs for TransAtlantic Inter-Society Consensus types C and D femoropopliteal artery disease has provided favorable results ≤12 months but no prospective studies performed longer term follow-up assessment. Methods Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency (i.e., freedom from the combined endpoint of clinically driven target lesion revascularization and >50% restenosis in the treated lesion as appraised by a duplex ultrasound peak systolic velocity ratio of >2.4) at 24 months. Secondary endpoints included major adverse events (the composite of death, target limb amputation, thrombosis at the target lesion, or clinically driven nontarget lesion revascularization), changes in Rutherford class, and quality of life ≤24 months post-procedure. Results A total of 105 patients (age 68 ± 9 years; 81.9% men) successfully treated with PCBs were included (treated lesion length was 251 ± 71 mm; 49.5% total occlusions). The 24-month follow-up data were available in 98 patients; they showed a primary patency rate of 70.4%, with major adverse events occurred in 10 patients (10.2%, 5 non–procedure-related deaths) and persistently significant clinical benefits in Rutherford class (51% of asymptomatic patients at 24 months). Conclusions PCBs benefits on primary patency and target vessel revascularization satisfactorily extend over 24 months in patients undergoing percutaneous transluminal angioplasty for symptomatic femoropopliteal disease. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: 2-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease: Evidence From the SFA-Long Study ###Abstract: Objectives The aim of this study was to appraise 2-year outcomes after percutaneous transluminal angioplasty of long femoropopliteal artery disease using paclitaxel-coated balloons (PCBs). Background Percutaneous transluminal angioplasty with PCBs for TransAtlantic Inter-Society Consensus types C and D femoropopliteal artery disease has provided favorable results ≤12 months but no prospective studies performed longer term follow-up assessment. Methods Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency (i.e., freedom from the combined endpoint of clinically driven target lesion revascularization and >50% restenosis in the treated lesion as appraised by a duplex ultrasound peak systolic velocity ratio of >2.4) at 24 months. Secondary endpoints included major adverse events (the composite of death, target limb amputation, thrombosis at the target lesion, or clinically driven nontarget lesion revascularization), changes in Rutherford class, and quality of life ≤24 months post-procedure. Results A total of 105 patients (age 68 ± 9 years; 81.9% men) successfully treated with PCBs were included (treated lesion length was 251 ± 71 mm; 49.5% total occlusions). The 24-month follow-up data were available in 98 patients; they showed a primary patency rate of 70.4%, with major adverse events occurred in 10 patients (10.2%, 5 non–procedure-related deaths) and persistently significant clinical benefits in Rutherford class (51% of asymptomatic patients at 24 months). Conclusions PCBs benefits on primary patency and target vessel revascularization satisfactorily extend over 24 months in patients undergoing percutaneous transluminal angioplasty for symptomatic femoropopliteal disease. [/INST] Include </s>
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Micari 2018
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Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study
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Objectives: The IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. Background: Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. Methods: The IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months. Results: Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months. Conclusions: This real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (IN.PACT Global Clinical Study; NCT01609296)
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study ###Abstract: Objectives: The IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. Background: Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. Methods: The IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months. Results: Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months. Conclusions: This real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (IN.PACT Global Clinical Study; NCT01609296) [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study ###Abstract: Objectives: The IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. Background: Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. Methods: The IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months. Results: Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months. Conclusions: This real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (IN.PACT Global Clinical Study; NCT01609296) [/INST] Include </s>
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Nugteren 2020
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Midterm Outcomes of Drug-Coated Balloon Angioplasty in Femoropopliteal Lesions in a Daily Practice Cohort
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Background: Most previous drug-coated balloon (DCB) angioplasty studies used strict inclusion and exclusion criteria and therefore might not be representative for daily practice. This study was performed to evaluate the midterm outcomes of DCB angioplasty in femoropopliteal artery disease and to identify risk factors for restenosis. Materials and methods: All patients treated with DCB angioplasty between January 2015 and September 2016 were included. Provisional stents were placed if indicated. Data were retrospectively collected from digital patient records. No exclusion criteria were applied. The primary end point was primary patency. Secondary end points were primary assisted patency, secondary patency, clinically driven target lesion revascularization (CD-TLR) and major adverse events. All end points were calculated with the Kaplan-Meier analysis. The univariable and multivariable Cox regression analyses were performed to identify risk factors for restenosis. Results: A total of 109 patients (113 legs) were included (45% male; mean age, 72 ± 10). The rate of critical limb ischemia was 52% and total occlusions were treated in 38%. The mean follow-up was 24 ± 13 months. Primary patency rates were 87%, 79%, and 61% at 1, 2, and 3 years, respectively. Primary assisted patency rates were 95%; 89%, and 79%; secondary patency rates were 99%, 97%, and 91%; and CD-TLR rates were 6.9%, 14.3%, and 20.6% at 1, 2, and 3 years, respectively. Overall mortality and major target limb amputation rates were 18% and 5% at 3 years. Multivariable analysis demonstrated that only Trans-Atlantic Inter-Society Consensus (TASC) D lesions were associated with restenosis (P = 0.008). Conclusions: DCB angioplasty is an effective and safe treatment option for femoropopliteal lesions in daily practice with excellent 1- and 2-year results. The 3-year results were slightly less favorable, which may be caused by the ongoing vascular disease or a late “catch-up” phenomenon. Only TASC D lesions were associated with loss of primary patency after adjustment for confounders.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Midterm Outcomes of Drug-Coated Balloon Angioplasty in Femoropopliteal Lesions in a Daily Practice Cohort ###Abstract: Background: Most previous drug-coated balloon (DCB) angioplasty studies used strict inclusion and exclusion criteria and therefore might not be representative for daily practice. This study was performed to evaluate the midterm outcomes of DCB angioplasty in femoropopliteal artery disease and to identify risk factors for restenosis. Materials and methods: All patients treated with DCB angioplasty between January 2015 and September 2016 were included. Provisional stents were placed if indicated. Data were retrospectively collected from digital patient records. No exclusion criteria were applied. The primary end point was primary patency. Secondary end points were primary assisted patency, secondary patency, clinically driven target lesion revascularization (CD-TLR) and major adverse events. All end points were calculated with the Kaplan-Meier analysis. The univariable and multivariable Cox regression analyses were performed to identify risk factors for restenosis. Results: A total of 109 patients (113 legs) were included (45% male; mean age, 72 ± 10). The rate of critical limb ischemia was 52% and total occlusions were treated in 38%. The mean follow-up was 24 ± 13 months. Primary patency rates were 87%, 79%, and 61% at 1, 2, and 3 years, respectively. Primary assisted patency rates were 95%; 89%, and 79%; secondary patency rates were 99%, 97%, and 91%; and CD-TLR rates were 6.9%, 14.3%, and 20.6% at 1, 2, and 3 years, respectively. Overall mortality and major target limb amputation rates were 18% and 5% at 3 years. Multivariable analysis demonstrated that only Trans-Atlantic Inter-Society Consensus (TASC) D lesions were associated with restenosis (P = 0.008). Conclusions: DCB angioplasty is an effective and safe treatment option for femoropopliteal lesions in daily practice with excellent 1- and 2-year results. The 3-year results were slightly less favorable, which may be caused by the ongoing vascular disease or a late “catch-up” phenomenon. Only TASC D lesions were associated with loss of primary patency after adjustment for confounders. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Midterm Outcomes of Drug-Coated Balloon Angioplasty in Femoropopliteal Lesions in a Daily Practice Cohort ###Abstract: Background: Most previous drug-coated balloon (DCB) angioplasty studies used strict inclusion and exclusion criteria and therefore might not be representative for daily practice. This study was performed to evaluate the midterm outcomes of DCB angioplasty in femoropopliteal artery disease and to identify risk factors for restenosis. Materials and methods: All patients treated with DCB angioplasty between January 2015 and September 2016 were included. Provisional stents were placed if indicated. Data were retrospectively collected from digital patient records. No exclusion criteria were applied. The primary end point was primary patency. Secondary end points were primary assisted patency, secondary patency, clinically driven target lesion revascularization (CD-TLR) and major adverse events. All end points were calculated with the Kaplan-Meier analysis. The univariable and multivariable Cox regression analyses were performed to identify risk factors for restenosis. Results: A total of 109 patients (113 legs) were included (45% male; mean age, 72 ± 10). The rate of critical limb ischemia was 52% and total occlusions were treated in 38%. The mean follow-up was 24 ± 13 months. Primary patency rates were 87%, 79%, and 61% at 1, 2, and 3 years, respectively. Primary assisted patency rates were 95%; 89%, and 79%; secondary patency rates were 99%, 97%, and 91%; and CD-TLR rates were 6.9%, 14.3%, and 20.6% at 1, 2, and 3 years, respectively. Overall mortality and major target limb amputation rates were 18% and 5% at 3 years. Multivariable analysis demonstrated that only Trans-Atlantic Inter-Society Consensus (TASC) D lesions were associated with restenosis (P = 0.008). Conclusions: DCB angioplasty is an effective and safe treatment option for femoropopliteal lesions in daily practice with excellent 1- and 2-year results. The 3-year results were slightly less favorable, which may be caused by the ongoing vascular disease or a late “catch-up” phenomenon. Only TASC D lesions were associated with loss of primary patency after adjustment for confounders. [/INST] Include </s>
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Ott 2017
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ISAR-PEBIS (Paclitaxel-Eluting Balloon Versus Conventional Balloon Angioplasty for In-Stent Restenosis of Superficial Femoral Artery): A Randomized Trial
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Background Paclitaxel‐eluting balloon (PEB) angioplasty has superior efficacy compared with conventional balloon angioplasty (BA) for de novo lesions of superficial femoral artery (SFA). Studies investigating the angiographic and clinical performance of PEB angioplasty versus BA for in‐stent restenosis of SFA are limited. We performed a randomized trial to investigate angiographic and clinical performance of PEB versus BA for in‐stent restenosis of SFA. Methods and Results Patients with symptomatic in‐stent restenosis of SFA were randomly assigned to either PEB or BA at 2 centers in Munich, Germany. The primary end point was the percentage diameter stenosis at 6‐ to 8‐month follow‐up angiography. Secondary end points were the rate of binary restenosis at follow‐up angiography and target lesion revascularization, target vessel thrombosis, ipsilateral amputation, bypass surgery of the affected limb, and all‐cause mortality at 24‐month follow‐up. Seventy patients were assigned to PEB (n=36) or BA (n=34). Mean lesion length was 139±67 mm, and roughly one third of lesions were completely occluded at the time of the index procedure. At control angiography, the percentage diameter stenosis (44±33% versus 65±33%, P=0.01) and binary restenosis were significantly reduced with PEB versus BA (30% versus 59%, P=0.03). At 24‐month follow‐up, PEB was associated with a significant reduction of target lesion revascularization in comparison to BA (19% versus 50%, P=0.007). There was no difference with respect to other outcomes of interest.Conclusions
In patients with in‐stent restenosis of SFA, a percutaneous therapy with PEB compared with BA has superior angiographic performance at 6 to 8 months and improved clinical efficacy up to 24‐month follow‐up.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: ISAR-PEBIS (Paclitaxel-Eluting Balloon Versus Conventional Balloon Angioplasty for In-Stent Restenosis of Superficial Femoral Artery): A Randomized Trial ###Abstract: Background Paclitaxel‐eluting balloon (PEB) angioplasty has superior efficacy compared with conventional balloon angioplasty (BA) for de novo lesions of superficial femoral artery (SFA). Studies investigating the angiographic and clinical performance of PEB angioplasty versus BA for in‐stent restenosis of SFA are limited. We performed a randomized trial to investigate angiographic and clinical performance of PEB versus BA for in‐stent restenosis of SFA. Methods and Results Patients with symptomatic in‐stent restenosis of SFA were randomly assigned to either PEB or BA at 2 centers in Munich, Germany. The primary end point was the percentage diameter stenosis at 6‐ to 8‐month follow‐up angiography. Secondary end points were the rate of binary restenosis at follow‐up angiography and target lesion revascularization, target vessel thrombosis, ipsilateral amputation, bypass surgery of the affected limb, and all‐cause mortality at 24‐month follow‐up. Seventy patients were assigned to PEB (n=36) or BA (n=34). Mean lesion length was 139±67 mm, and roughly one third of lesions were completely occluded at the time of the index procedure. At control angiography, the percentage diameter stenosis (44±33% versus 65±33%, P=0.01) and binary restenosis were significantly reduced with PEB versus BA (30% versus 59%, P=0.03). At 24‐month follow‐up, PEB was associated with a significant reduction of target lesion revascularization in comparison to BA (19% versus 50%, P=0.007). There was no difference with respect to other outcomes of interest.Conclusions
In patients with in‐stent restenosis of SFA, a percutaneous therapy with PEB compared with BA has superior angiographic performance at 6 to 8 months and improved clinical efficacy up to 24‐month follow‐up. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: ISAR-PEBIS (Paclitaxel-Eluting Balloon Versus Conventional Balloon Angioplasty for In-Stent Restenosis of Superficial Femoral Artery): A Randomized Trial ###Abstract: Background Paclitaxel‐eluting balloon (PEB) angioplasty has superior efficacy compared with conventional balloon angioplasty (BA) for de novo lesions of superficial femoral artery (SFA). Studies investigating the angiographic and clinical performance of PEB angioplasty versus BA for in‐stent restenosis of SFA are limited. We performed a randomized trial to investigate angiographic and clinical performance of PEB versus BA for in‐stent restenosis of SFA. Methods and Results Patients with symptomatic in‐stent restenosis of SFA were randomly assigned to either PEB or BA at 2 centers in Munich, Germany. The primary end point was the percentage diameter stenosis at 6‐ to 8‐month follow‐up angiography. Secondary end points were the rate of binary restenosis at follow‐up angiography and target lesion revascularization, target vessel thrombosis, ipsilateral amputation, bypass surgery of the affected limb, and all‐cause mortality at 24‐month follow‐up. Seventy patients were assigned to PEB (n=36) or BA (n=34). Mean lesion length was 139±67 mm, and roughly one third of lesions were completely occluded at the time of the index procedure. At control angiography, the percentage diameter stenosis (44±33% versus 65±33%, P=0.01) and binary restenosis were significantly reduced with PEB versus BA (30% versus 59%, P=0.03). At 24‐month follow‐up, PEB was associated with a significant reduction of target lesion revascularization in comparison to BA (19% versus 50%, P=0.007). There was no difference with respect to other outcomes of interest.Conclusions
In patients with in‐stent restenosis of SFA, a percutaneous therapy with PEB compared with BA has superior angiographic performance at 6 to 8 months and improved clinical efficacy up to 24‐month follow‐up. [/INST] Include </s>
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Pang 2020
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Randomized Controlled Trial for Paclitaxel-coated Balloon versus Plain Balloon Angioplasty in Dysfunctional Hemodialysis Vascular Access: 12-month Outcome from a Nonsponsored Trial
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Background: Plain balloon angioplasty is regarded as the mainstay of treatment for failing vascular access with high success rate, but the poor treatment durability creates significant workload and increases patient morbidity. The study aims to compare target lesion primary patency rate at 12 months between paclitaxel-coated balloon (DCB) versus plain old balloon angioplasty (POBA) for treatment of dysfunctional vascular access. Methods: This nonsponsored-randomized trial enrolled 40 patients with dysfunctional dialysis access at a single center. Patients were randomized into In.Pact Admiral Paclitaxel DCB or POBA after lesion crossing regardless of lesion type. Patients are followed up under surveillance protocol. Patients, hemodialysis staff, and sonographer are blinded to the treatment arms. Twelve-month primary patency rate in both arms are evaluated. Results: 40 patients were recruited since June 2016 and were allocated to the DCB or POBA group. The mean age is 58 and 57 years with comparable demographic parameters. The locations of target lesion were comparable in both groups (juxta and arteriovenous anastomosis, cannulation site, and fistula/graft), with similar mean target lesion stenosis 69.8 +/− 15.8% for DCB and 69.5 +/− 13.6% for POBA (P = 0.95), and the lesion length for DCB is 45.8 +/− 38.4 mm and 50.2 +/− 33.5 mm for POBA (P = 0.70). Patients in DCB performed significantly better in terms of primary patency at 6 months 85% versus 55% (P = 0.007). The superiority in primary patency in DCB group exists at 12 months 65% versus 30% (P = 0.007). Conclusions: Paclitaxel balloon angioplasty approach provides significant better primary patency in dysfunctional arteriovenous access at 12 months in our nonsponsored-randomized trial.
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Include
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Randomized Controlled Trial for Paclitaxel-coated Balloon versus Plain Balloon Angioplasty in Dysfunctional Hemodialysis Vascular Access: 12-month Outcome from a Nonsponsored Trial ###Abstract: Background: Plain balloon angioplasty is regarded as the mainstay of treatment for failing vascular access with high success rate, but the poor treatment durability creates significant workload and increases patient morbidity. The study aims to compare target lesion primary patency rate at 12 months between paclitaxel-coated balloon (DCB) versus plain old balloon angioplasty (POBA) for treatment of dysfunctional vascular access. Methods: This nonsponsored-randomized trial enrolled 40 patients with dysfunctional dialysis access at a single center. Patients were randomized into In.Pact Admiral Paclitaxel DCB or POBA after lesion crossing regardless of lesion type. Patients are followed up under surveillance protocol. Patients, hemodialysis staff, and sonographer are blinded to the treatment arms. Twelve-month primary patency rate in both arms are evaluated. Results: 40 patients were recruited since June 2016 and were allocated to the DCB or POBA group. The mean age is 58 and 57 years with comparable demographic parameters. The locations of target lesion were comparable in both groups (juxta and arteriovenous anastomosis, cannulation site, and fistula/graft), with similar mean target lesion stenosis 69.8 +/− 15.8% for DCB and 69.5 +/− 13.6% for POBA (P = 0.95), and the lesion length for DCB is 45.8 +/− 38.4 mm and 50.2 +/− 33.5 mm for POBA (P = 0.70). Patients in DCB performed significantly better in terms of primary patency at 6 months 85% versus 55% (P = 0.007). The superiority in primary patency in DCB group exists at 12 months 65% versus 30% (P = 0.007). Conclusions: Paclitaxel balloon angioplasty approach provides significant better primary patency in dysfunctional arteriovenous access at 12 months in our nonsponsored-randomized trial. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Randomized Controlled Trial for Paclitaxel-coated Balloon versus Plain Balloon Angioplasty in Dysfunctional Hemodialysis Vascular Access: 12-month Outcome from a Nonsponsored Trial ###Abstract: Background: Plain balloon angioplasty is regarded as the mainstay of treatment for failing vascular access with high success rate, but the poor treatment durability creates significant workload and increases patient morbidity. The study aims to compare target lesion primary patency rate at 12 months between paclitaxel-coated balloon (DCB) versus plain old balloon angioplasty (POBA) for treatment of dysfunctional vascular access. Methods: This nonsponsored-randomized trial enrolled 40 patients with dysfunctional dialysis access at a single center. Patients were randomized into In.Pact Admiral Paclitaxel DCB or POBA after lesion crossing regardless of lesion type. Patients are followed up under surveillance protocol. Patients, hemodialysis staff, and sonographer are blinded to the treatment arms. Twelve-month primary patency rate in both arms are evaluated. Results: 40 patients were recruited since June 2016 and were allocated to the DCB or POBA group. The mean age is 58 and 57 years with comparable demographic parameters. The locations of target lesion were comparable in both groups (juxta and arteriovenous anastomosis, cannulation site, and fistula/graft), with similar mean target lesion stenosis 69.8 +/− 15.8% for DCB and 69.5 +/− 13.6% for POBA (P = 0.95), and the lesion length for DCB is 45.8 +/− 38.4 mm and 50.2 +/− 33.5 mm for POBA (P = 0.70). Patients in DCB performed significantly better in terms of primary patency at 6 months 85% versus 55% (P = 0.007). The superiority in primary patency in DCB group exists at 12 months 65% versus 30% (P = 0.007). Conclusions: Paclitaxel balloon angioplasty approach provides significant better primary patency in dysfunctional arteriovenous access at 12 months in our nonsponsored-randomized trial. [/INST] Include </s>
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Reijnen 2019
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Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study
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Purpose: To report a post hoc analysis performed to evaluate 1-year safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in subjects with critical limb ischemia (CLI) enrolled in the IN.PACT Global study (ClinicalTrials.gov identifier NCT01609296). Materials and Methods: Of 1535 subjects enrolled in the study, 156 participants (mean age 71.8±10.4; 87 men) with CLI (Rutherford categories 4,5) were treated with DCB angioplasty in 194 femoropopliteal lesions. This cohort was compared to the 1246 subjects (mean age 68.2±10.0 years; 864 men) with intermittent claudication (IC) treated for 1573 lesions. The CLI cohort had longer lesions (13.9±10.6 vs 11.9±9.4 cm, p=0.009) and a higher calcification rate (76.8% vs 67.7%, p=0.011). Major adverse events [MAE; composite of all-cause mortality, clinically-driven target lesion revascularization (CD-TLR), major (above-ankle) target limb amputation, and thrombosis at the target lesion site], lesion and vessel revascularization rates, and EuroQol-5D were assessed through 1 year. The Kaplan-Meier method was used to estimate survival, CD-TLR, and amputation events; estimates are presented with the 95% confidence intervals (CI). Results: Estimates of 12-month freedom from major target limb amputation were 98.6% (95% CI 96.7% to 100.0%) in subjects with CLI and 99.9% (95% CI 99.8% to 100.0%) in subjects with IC (p=0.002). Freedom from CD-TLR through 12 months was 86.3% (95% CI 80.6% to 91.9%) in CLI subjects and 93.4% (95% CI 91.9% to 94.8%) in IC subjects (p<0.001). The MAE rate through 12 months was higher in CLI subjects (22.5% vs 10.7%, p<0.001), and CLI patients had poorer overall survival (93.0%, 95% CI 88.9% to 97.2%) than IC subjects (97.0%, 95% CI 96.0% to 97.9%, p=0.011). Health status significantly improved in all domains at 6 and 12 months in both groups. Conclusion: Treatment of femoropopliteal disease with DCB in CLI patients is safe through 12-month follow-up, with a low major amputation rate of 1.4%. The rates of MAE and CD-TLR were higher in CLI subjects and reinterventions were required sooner. Additional research is needed to evaluate long-term outcomes of DCB treatment for femoropopliteal lesions in CLI patients.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study ###Abstract: Purpose: To report a post hoc analysis performed to evaluate 1-year safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in subjects with critical limb ischemia (CLI) enrolled in the IN.PACT Global study (ClinicalTrials.gov identifier NCT01609296). Materials and Methods: Of 1535 subjects enrolled in the study, 156 participants (mean age 71.8±10.4; 87 men) with CLI (Rutherford categories 4,5) were treated with DCB angioplasty in 194 femoropopliteal lesions. This cohort was compared to the 1246 subjects (mean age 68.2±10.0 years; 864 men) with intermittent claudication (IC) treated for 1573 lesions. The CLI cohort had longer lesions (13.9±10.6 vs 11.9±9.4 cm, p=0.009) and a higher calcification rate (76.8% vs 67.7%, p=0.011). Major adverse events [MAE; composite of all-cause mortality, clinically-driven target lesion revascularization (CD-TLR), major (above-ankle) target limb amputation, and thrombosis at the target lesion site], lesion and vessel revascularization rates, and EuroQol-5D were assessed through 1 year. The Kaplan-Meier method was used to estimate survival, CD-TLR, and amputation events; estimates are presented with the 95% confidence intervals (CI). Results: Estimates of 12-month freedom from major target limb amputation were 98.6% (95% CI 96.7% to 100.0%) in subjects with CLI and 99.9% (95% CI 99.8% to 100.0%) in subjects with IC (p=0.002). Freedom from CD-TLR through 12 months was 86.3% (95% CI 80.6% to 91.9%) in CLI subjects and 93.4% (95% CI 91.9% to 94.8%) in IC subjects (p<0.001). The MAE rate through 12 months was higher in CLI subjects (22.5% vs 10.7%, p<0.001), and CLI patients had poorer overall survival (93.0%, 95% CI 88.9% to 97.2%) than IC subjects (97.0%, 95% CI 96.0% to 97.9%, p=0.011). Health status significantly improved in all domains at 6 and 12 months in both groups. Conclusion: Treatment of femoropopliteal disease with DCB in CLI patients is safe through 12-month follow-up, with a low major amputation rate of 1.4%. The rates of MAE and CD-TLR were higher in CLI subjects and reinterventions were required sooner. Additional research is needed to evaluate long-term outcomes of DCB treatment for femoropopliteal lesions in CLI patients. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study ###Abstract: Purpose: To report a post hoc analysis performed to evaluate 1-year safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in subjects with critical limb ischemia (CLI) enrolled in the IN.PACT Global study (ClinicalTrials.gov identifier NCT01609296). Materials and Methods: Of 1535 subjects enrolled in the study, 156 participants (mean age 71.8±10.4; 87 men) with CLI (Rutherford categories 4,5) were treated with DCB angioplasty in 194 femoropopliteal lesions. This cohort was compared to the 1246 subjects (mean age 68.2±10.0 years; 864 men) with intermittent claudication (IC) treated for 1573 lesions. The CLI cohort had longer lesions (13.9±10.6 vs 11.9±9.4 cm, p=0.009) and a higher calcification rate (76.8% vs 67.7%, p=0.011). Major adverse events [MAE; composite of all-cause mortality, clinically-driven target lesion revascularization (CD-TLR), major (above-ankle) target limb amputation, and thrombosis at the target lesion site], lesion and vessel revascularization rates, and EuroQol-5D were assessed through 1 year. The Kaplan-Meier method was used to estimate survival, CD-TLR, and amputation events; estimates are presented with the 95% confidence intervals (CI). Results: Estimates of 12-month freedom from major target limb amputation were 98.6% (95% CI 96.7% to 100.0%) in subjects with CLI and 99.9% (95% CI 99.8% to 100.0%) in subjects with IC (p=0.002). Freedom from CD-TLR through 12 months was 86.3% (95% CI 80.6% to 91.9%) in CLI subjects and 93.4% (95% CI 91.9% to 94.8%) in IC subjects (p<0.001). The MAE rate through 12 months was higher in CLI subjects (22.5% vs 10.7%, p<0.001), and CLI patients had poorer overall survival (93.0%, 95% CI 88.9% to 97.2%) than IC subjects (97.0%, 95% CI 96.0% to 97.9%, p=0.011). Health status significantly improved in all domains at 6 and 12 months in both groups. Conclusion: Treatment of femoropopliteal disease with DCB in CLI patients is safe through 12-month follow-up, with a low major amputation rate of 1.4%. The rates of MAE and CD-TLR were higher in CLI subjects and reinterventions were required sooner. Additional research is needed to evaluate long-term outcomes of DCB treatment for femoropopliteal lesions in CLI patients. [/INST] Include </s>
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Roh 2019
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Risk Factors for Restenosis after Drug-coated Balloon Angioplasty for Complex Femoropopliteal Arterial Occlusive Disease
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Background: Currently, there exist limited data on patient outcomes following the use of drug-coated balloons (DCBs) to treat complex femoropopliteal arterial occlusive lesions. The aim of the this study is to investigate the outcomes of patient treated with DCBs and to identify the predictors of restenosis. Methods: We retrospectively investigated medical records from 120 patients (137 limbs) treated with DCBs for femoropopliteal lesions at a single center between 2013 and 2016. Primary patency, target lesion revascularization (TLR), and risk factors of restenosis were analyzed. Results: There were 80 de novo and 57 in-stent restenosis lesions. Mean lesion length was 22.2 ± 11.6 cm. The clinical primary patency was 85.2% at 1 year and 65.3% after 2 years. The TLR-free survival rate was 93.0% at 1 year and 87.1% after 2 years. Critical limb ischemia (CLI; hazard ratio [HR] 5.80, 95% confidence interval [CI] 1.26–26.68, P = 0.024) and hypercholesterolemia (HR 4.66, 95% CI 1.30–16.76, P = 0.018) were identified as independent predictors of restenosis. In addition, nonuse of cilostazol and popliteal artery involvement showed trends toward an increased risk of restenosis. Conclusions: Treatment with DCBs showed excellent primary patency and TLR-free survival at 1 year after the procedure. However, the primary patency continuously deteriorated beyond 1 year, suggesting a late catch-up phenomenon. The risk of restenosis after treatment with DCBs was significantly associated with CLI and hypercholesterolemia.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Risk Factors for Restenosis after Drug-coated Balloon Angioplasty for Complex Femoropopliteal Arterial Occlusive Disease ###Abstract: Background: Currently, there exist limited data on patient outcomes following the use of drug-coated balloons (DCBs) to treat complex femoropopliteal arterial occlusive lesions. The aim of the this study is to investigate the outcomes of patient treated with DCBs and to identify the predictors of restenosis. Methods: We retrospectively investigated medical records from 120 patients (137 limbs) treated with DCBs for femoropopliteal lesions at a single center between 2013 and 2016. Primary patency, target lesion revascularization (TLR), and risk factors of restenosis were analyzed. Results: There were 80 de novo and 57 in-stent restenosis lesions. Mean lesion length was 22.2 ± 11.6 cm. The clinical primary patency was 85.2% at 1 year and 65.3% after 2 years. The TLR-free survival rate was 93.0% at 1 year and 87.1% after 2 years. Critical limb ischemia (CLI; hazard ratio [HR] 5.80, 95% confidence interval [CI] 1.26–26.68, P = 0.024) and hypercholesterolemia (HR 4.66, 95% CI 1.30–16.76, P = 0.018) were identified as independent predictors of restenosis. In addition, nonuse of cilostazol and popliteal artery involvement showed trends toward an increased risk of restenosis. Conclusions: Treatment with DCBs showed excellent primary patency and TLR-free survival at 1 year after the procedure. However, the primary patency continuously deteriorated beyond 1 year, suggesting a late catch-up phenomenon. The risk of restenosis after treatment with DCBs was significantly associated with CLI and hypercholesterolemia. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Risk Factors for Restenosis after Drug-coated Balloon Angioplasty for Complex Femoropopliteal Arterial Occlusive Disease ###Abstract: Background: Currently, there exist limited data on patient outcomes following the use of drug-coated balloons (DCBs) to treat complex femoropopliteal arterial occlusive lesions. The aim of the this study is to investigate the outcomes of patient treated with DCBs and to identify the predictors of restenosis. Methods: We retrospectively investigated medical records from 120 patients (137 limbs) treated with DCBs for femoropopliteal lesions at a single center between 2013 and 2016. Primary patency, target lesion revascularization (TLR), and risk factors of restenosis were analyzed. Results: There were 80 de novo and 57 in-stent restenosis lesions. Mean lesion length was 22.2 ± 11.6 cm. The clinical primary patency was 85.2% at 1 year and 65.3% after 2 years. The TLR-free survival rate was 93.0% at 1 year and 87.1% after 2 years. Critical limb ischemia (CLI; hazard ratio [HR] 5.80, 95% confidence interval [CI] 1.26–26.68, P = 0.024) and hypercholesterolemia (HR 4.66, 95% CI 1.30–16.76, P = 0.018) were identified as independent predictors of restenosis. In addition, nonuse of cilostazol and popliteal artery involvement showed trends toward an increased risk of restenosis. Conclusions: Treatment with DCBs showed excellent primary patency and TLR-free survival at 1 year after the procedure. However, the primary patency continuously deteriorated beyond 1 year, suggesting a late catch-up phenomenon. The risk of restenosis after treatment with DCBs was significantly associated with CLI and hypercholesterolemia. [/INST] Include </s>
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Roosen 2017
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Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: Results of a randomized clinical trial(Article)
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BACKGROUND: Fistula failure is frequently caused by stenosis. Percutaneous transluminal angioplasty (PTA) has a poor patency, as it induces intima hyperplasia and hence recurrent stenosis. Paclitaxel-coated balloons (PCB) have shown good results in treating stenosis in coronary and lower extremity arteries compared to conventional balloon angioplasty (CBA). This study compares secondary patency rates of PCB to CBA in recurrent stenosis in haemodialysis fistula. METHODS: In this multicenter trial 34 patients with recurrent stenosis in their fistula were randomized for either CBA (N.=18) or PCB (N.=16). Follow-up interval was set 3, 6, 9 and 12 months with duplex ultrasonography. Primary endpoints were occlusion, re-stenosis grade >50% or blood flow measurements <600 mL/min. Reintervention was planned within two to seven days. RESULTS: One patient was lost in follow up. One patient in the PCB group had an early complication with thrombosis of the fistula due to an allergic reaction to the contrast agent. Another patient had a subtotal occlusion a few hours after intervention. The cause was not entirely clear. 5 patients reached their endpoint prematurely by the cause of death. In this total group of 34 patients no beneficial effects were seen in the PCB group. The primary patency defined as the target lesion revascularization (TLR) free interval in this group was 130 days compared to the mean TLR free interval for CBA of 189 days (P=0.197). CONCLUSIONS: Our study does not support the use of paclitaxel coated balloons to prevent recurrent stenosis in hemodialysis fistulae. © 2017 EDIZIONI MINERVA MEDICA.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: Results of a randomized clinical trial(Article) ###Abstract: BACKGROUND: Fistula failure is frequently caused by stenosis. Percutaneous transluminal angioplasty (PTA) has a poor patency, as it induces intima hyperplasia and hence recurrent stenosis. Paclitaxel-coated balloons (PCB) have shown good results in treating stenosis in coronary and lower extremity arteries compared to conventional balloon angioplasty (CBA). This study compares secondary patency rates of PCB to CBA in recurrent stenosis in haemodialysis fistula. METHODS: In this multicenter trial 34 patients with recurrent stenosis in their fistula were randomized for either CBA (N.=18) or PCB (N.=16). Follow-up interval was set 3, 6, 9 and 12 months with duplex ultrasonography. Primary endpoints were occlusion, re-stenosis grade >50% or blood flow measurements <600 mL/min. Reintervention was planned within two to seven days. RESULTS: One patient was lost in follow up. One patient in the PCB group had an early complication with thrombosis of the fistula due to an allergic reaction to the contrast agent. Another patient had a subtotal occlusion a few hours after intervention. The cause was not entirely clear. 5 patients reached their endpoint prematurely by the cause of death. In this total group of 34 patients no beneficial effects were seen in the PCB group. The primary patency defined as the target lesion revascularization (TLR) free interval in this group was 130 days compared to the mean TLR free interval for CBA of 189 days (P=0.197). CONCLUSIONS: Our study does not support the use of paclitaxel coated balloons to prevent recurrent stenosis in hemodialysis fistulae. © 2017 EDIZIONI MINERVA MEDICA. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: Results of a randomized clinical trial(Article) ###Abstract: BACKGROUND: Fistula failure is frequently caused by stenosis. Percutaneous transluminal angioplasty (PTA) has a poor patency, as it induces intima hyperplasia and hence recurrent stenosis. Paclitaxel-coated balloons (PCB) have shown good results in treating stenosis in coronary and lower extremity arteries compared to conventional balloon angioplasty (CBA). This study compares secondary patency rates of PCB to CBA in recurrent stenosis in haemodialysis fistula. METHODS: In this multicenter trial 34 patients with recurrent stenosis in their fistula were randomized for either CBA (N.=18) or PCB (N.=16). Follow-up interval was set 3, 6, 9 and 12 months with duplex ultrasonography. Primary endpoints were occlusion, re-stenosis grade >50% or blood flow measurements <600 mL/min. Reintervention was planned within two to seven days. RESULTS: One patient was lost in follow up. One patient in the PCB group had an early complication with thrombosis of the fistula due to an allergic reaction to the contrast agent. Another patient had a subtotal occlusion a few hours after intervention. The cause was not entirely clear. 5 patients reached their endpoint prematurely by the cause of death. In this total group of 34 patients no beneficial effects were seen in the PCB group. The primary patency defined as the target lesion revascularization (TLR) free interval in this group was 130 days compared to the mean TLR free interval for CBA of 189 days (P=0.197). CONCLUSIONS: Our study does not support the use of paclitaxel coated balloons to prevent recurrent stenosis in hemodialysis fistulae. © 2017 EDIZIONI MINERVA MEDICA. [/INST] Include </s>
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Salisbury 2016
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Cost-Effectiveness of Endovascular Femoropopliteal Intervention Using Drug-Coated Balloons Versus Standard Percutaneous Transluminal Angioplasty: Results From the IN.PACT SFA II Trial
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Objectives The aim of this study was to evaluate the cost-effectiveness of drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA). Background Recent trials have reported lower rates of target lesion revascularization with DCB angioplasty versus standard PTA. However, the cost-effectiveness of DCB angioplasty is unknown. Methods A prospective economic study was performed alongside the IN.PACT SFA II (IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA]) trial, which randomized 181 patients with femoropopliteal disease to the IN.PACT DCB versus standard PTA. Resource use data were collected over 2-year follow-up, and costs were assigned using resource-based accounting and billing data. Health utilities were assessed using the EuroQol 5-dimensions questionnaire. Cost-effectiveness was assessed as cost per quality-adjusted life-year (QALY) gained using a decision-analytic model on the basis of empirical data from the trial assuming identical long-term mortality. Results Initial costs were $1,129 per patient higher with DCB angioplasty than standard PTA, driven by higher costs for the DCB itself. Between discharge and 24 months, target limb–related costs were $1,212 per patient lower with DCB angioplasty such that discounted 2-year costs were similar for the 2 groups ($11,277 vs. $11,359, p = 0.97), whereas QALYs tended to be greater among patients treated with DCBs (1.53 ± 0.44 vs. 1.47 ± 0.42, p = 0.40). The probability that DCB angioplasty is cost-effective compared with standard PTA was 70% using a threshold of $50,000 per QALY gained and 79% at a threshold of $150,000 per QALY gained. Conclusions For patients with femoropopliteal disease, DCB angioplasty is associated with better 2-year outcomes and similar target limb–related costs compared with standard PTA. Formal cost-effectiveness analysis on the basis of these results suggests that use of the DCB angioplasty is likely to be economically attractive.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Cost-Effectiveness of Endovascular Femoropopliteal Intervention Using Drug-Coated Balloons Versus Standard Percutaneous Transluminal Angioplasty: Results From the IN.PACT SFA II Trial ###Abstract: Objectives The aim of this study was to evaluate the cost-effectiveness of drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA). Background Recent trials have reported lower rates of target lesion revascularization with DCB angioplasty versus standard PTA. However, the cost-effectiveness of DCB angioplasty is unknown. Methods A prospective economic study was performed alongside the IN.PACT SFA II (IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA]) trial, which randomized 181 patients with femoropopliteal disease to the IN.PACT DCB versus standard PTA. Resource use data were collected over 2-year follow-up, and costs were assigned using resource-based accounting and billing data. Health utilities were assessed using the EuroQol 5-dimensions questionnaire. Cost-effectiveness was assessed as cost per quality-adjusted life-year (QALY) gained using a decision-analytic model on the basis of empirical data from the trial assuming identical long-term mortality. Results Initial costs were $1,129 per patient higher with DCB angioplasty than standard PTA, driven by higher costs for the DCB itself. Between discharge and 24 months, target limb–related costs were $1,212 per patient lower with DCB angioplasty such that discounted 2-year costs were similar for the 2 groups ($11,277 vs. $11,359, p = 0.97), whereas QALYs tended to be greater among patients treated with DCBs (1.53 ± 0.44 vs. 1.47 ± 0.42, p = 0.40). The probability that DCB angioplasty is cost-effective compared with standard PTA was 70% using a threshold of $50,000 per QALY gained and 79% at a threshold of $150,000 per QALY gained. Conclusions For patients with femoropopliteal disease, DCB angioplasty is associated with better 2-year outcomes and similar target limb–related costs compared with standard PTA. Formal cost-effectiveness analysis on the basis of these results suggests that use of the DCB angioplasty is likely to be economically attractive. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Cost-Effectiveness of Endovascular Femoropopliteal Intervention Using Drug-Coated Balloons Versus Standard Percutaneous Transluminal Angioplasty: Results From the IN.PACT SFA II Trial ###Abstract: Objectives The aim of this study was to evaluate the cost-effectiveness of drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA). Background Recent trials have reported lower rates of target lesion revascularization with DCB angioplasty versus standard PTA. However, the cost-effectiveness of DCB angioplasty is unknown. Methods A prospective economic study was performed alongside the IN.PACT SFA II (IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA]) trial, which randomized 181 patients with femoropopliteal disease to the IN.PACT DCB versus standard PTA. Resource use data were collected over 2-year follow-up, and costs were assigned using resource-based accounting and billing data. Health utilities were assessed using the EuroQol 5-dimensions questionnaire. Cost-effectiveness was assessed as cost per quality-adjusted life-year (QALY) gained using a decision-analytic model on the basis of empirical data from the trial assuming identical long-term mortality. Results Initial costs were $1,129 per patient higher with DCB angioplasty than standard PTA, driven by higher costs for the DCB itself. Between discharge and 24 months, target limb–related costs were $1,212 per patient lower with DCB angioplasty such that discounted 2-year costs were similar for the 2 groups ($11,277 vs. $11,359, p = 0.97), whereas QALYs tended to be greater among patients treated with DCBs (1.53 ± 0.44 vs. 1.47 ± 0.42, p = 0.40). The probability that DCB angioplasty is cost-effective compared with standard PTA was 70% using a threshold of $50,000 per QALY gained and 79% at a threshold of $150,000 per QALY gained. Conclusions For patients with femoropopliteal disease, DCB angioplasty is associated with better 2-year outcomes and similar target limb–related costs compared with standard PTA. Formal cost-effectiveness analysis on the basis of these results suggests that use of the DCB angioplasty is likely to be economically attractive. [/INST] Include </s>
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Scheinert 2018
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Drug-coated balloon treatment for femoropopliteal artery disease: The IN.PACT global study long lesion imaging cohort
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BACKGROUND: The IN.PACT Global Study was an international prospective single-arm clinical trial to evaluate the safety and effectiveness of a drug-coated balloon in the treatment of atherosclerotic disease of the superficial femoral and/or popliteal arteries (P1-P3) in subjects with intermittent claudication and/or rest pain. Prespecified subjects were selected for core-laboratory-adjudicated duplex ultrasound imaging, including a subcohort with long lesions (≥15 cm). METHODS AND RESULTS: Subjects were followed for 12 months. The primary safety end point was a composite of freedom from device- and procedure-related mortality through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 12 months. An independent Clinical Events Committee adjudicated all adverse events. The primary effectiveness end point was primary patency at 12 months (by duplex ultrasound). The long lesion imaging cohort had 157 subjects (164 lesions). Mean lesion length was 26.40±8.61 cm. Provisional stents were implanted in 39.4% (63/160) of lesions. Primary patency by Kaplan-Meier estimate was 91.1%, and freedom from clinically-driven target lesion revascularization was 94.2% at 12 months. The primary safety composite end point was achieved by 94.0% (126/134) of subjects. There were no device- or procedure-related deaths or major target limb amputations. CONCLUSIONS: The IN.PACT Admiral drug-coated balloon was safe and highly effective at 12 months after treatment in a rigorous independently adjudicated analysis of real-world subjects with lesions ≥15 cm in the superficial femoral and/or popliteal arteries (P1-P3). CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01609296.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon treatment for femoropopliteal artery disease: The IN.PACT global study long lesion imaging cohort ###Abstract: BACKGROUND: The IN.PACT Global Study was an international prospective single-arm clinical trial to evaluate the safety and effectiveness of a drug-coated balloon in the treatment of atherosclerotic disease of the superficial femoral and/or popliteal arteries (P1-P3) in subjects with intermittent claudication and/or rest pain. Prespecified subjects were selected for core-laboratory-adjudicated duplex ultrasound imaging, including a subcohort with long lesions (≥15 cm). METHODS AND RESULTS: Subjects were followed for 12 months. The primary safety end point was a composite of freedom from device- and procedure-related mortality through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 12 months. An independent Clinical Events Committee adjudicated all adverse events. The primary effectiveness end point was primary patency at 12 months (by duplex ultrasound). The long lesion imaging cohort had 157 subjects (164 lesions). Mean lesion length was 26.40±8.61 cm. Provisional stents were implanted in 39.4% (63/160) of lesions. Primary patency by Kaplan-Meier estimate was 91.1%, and freedom from clinically-driven target lesion revascularization was 94.2% at 12 months. The primary safety composite end point was achieved by 94.0% (126/134) of subjects. There were no device- or procedure-related deaths or major target limb amputations. CONCLUSIONS: The IN.PACT Admiral drug-coated balloon was safe and highly effective at 12 months after treatment in a rigorous independently adjudicated analysis of real-world subjects with lesions ≥15 cm in the superficial femoral and/or popliteal arteries (P1-P3). CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01609296. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon treatment for femoropopliteal artery disease: The IN.PACT global study long lesion imaging cohort ###Abstract: BACKGROUND: The IN.PACT Global Study was an international prospective single-arm clinical trial to evaluate the safety and effectiveness of a drug-coated balloon in the treatment of atherosclerotic disease of the superficial femoral and/or popliteal arteries (P1-P3) in subjects with intermittent claudication and/or rest pain. Prespecified subjects were selected for core-laboratory-adjudicated duplex ultrasound imaging, including a subcohort with long lesions (≥15 cm). METHODS AND RESULTS: Subjects were followed for 12 months. The primary safety end point was a composite of freedom from device- and procedure-related mortality through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 12 months. An independent Clinical Events Committee adjudicated all adverse events. The primary effectiveness end point was primary patency at 12 months (by duplex ultrasound). The long lesion imaging cohort had 157 subjects (164 lesions). Mean lesion length was 26.40±8.61 cm. Provisional stents were implanted in 39.4% (63/160) of lesions. Primary patency by Kaplan-Meier estimate was 91.1%, and freedom from clinically-driven target lesion revascularization was 94.2% at 12 months. The primary safety composite end point was achieved by 94.0% (126/134) of subjects. There were no device- or procedure-related deaths or major target limb amputations. CONCLUSIONS: The IN.PACT Admiral drug-coated balloon was safe and highly effective at 12 months after treatment in a rigorous independently adjudicated analysis of real-world subjects with lesions ≥15 cm in the superficial femoral and/or popliteal arteries (P1-P3). CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01609296. [/INST] Include </s>
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Schmidt 2016
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Drug-Coated Balloons for Complex Femoropopliteal Lesions 2-Year Results of a Real-World Registry
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Objectives The authors sought to investigate the efficacy of a drug-coated balloon (DCB) for treatment of complex femoropopliteal lesions. Background Superiority of DCBs compared with uncoated balloon angioplasty for femoropopliteal interventions has been demonstrated in randomized trials for short lesions. Their performance in complex lesions with higher restenosis rates is unclear. Methods Patency, target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints of femoropopliteal lesions in 288 limbs (n = 260) treated with the In.Pact Pacific or Admiral DCB (Medtronic, Minneapolis, Minnesota) were retrospectively analyzed for up to 2 years of follow-up. Predictors of restenosis were identified by logistic regression. Results Lesions were de novo in 51.7%, restenosis in 11.1%, and in-stent restenosis in 37.2%. Mean lesion length was 24.0 ± 10.2 cm, and 65.3% were occluded. Stent implantation was performed in 23.3%. Kaplan Meier estimates of primary patency were 79.2% and 53.7% for all lesions at 1 and 2 years, respectively, whereas freedom from TLR was 85.4% and 68.6%. Primary patency for in-stent restenosis treatment was 76.6% and 48.6%, and freedom from TLR was 83.0% and 58.7% at 1 and 2 years, respectively. Rutherford category improved from a median 3.3 to 1.2 at 1 year, and to 1.1 at 2 years. Major amputation rate was 2.1% at 2 years. No adverse events were thought to be attributable to the coating of the balloon. Conclusions These results suggest that DCB are safe and effective in delaying rather than preventing restenosis in long, complex lesions and restenosis of the femoropopliteal tract. Further studies are recommended to confirm these results.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloons for Complex Femoropopliteal Lesions 2-Year Results of a Real-World Registry ###Abstract: Objectives The authors sought to investigate the efficacy of a drug-coated balloon (DCB) for treatment of complex femoropopliteal lesions. Background Superiority of DCBs compared with uncoated balloon angioplasty for femoropopliteal interventions has been demonstrated in randomized trials for short lesions. Their performance in complex lesions with higher restenosis rates is unclear. Methods Patency, target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints of femoropopliteal lesions in 288 limbs (n = 260) treated with the In.Pact Pacific or Admiral DCB (Medtronic, Minneapolis, Minnesota) were retrospectively analyzed for up to 2 years of follow-up. Predictors of restenosis were identified by logistic regression. Results Lesions were de novo in 51.7%, restenosis in 11.1%, and in-stent restenosis in 37.2%. Mean lesion length was 24.0 ± 10.2 cm, and 65.3% were occluded. Stent implantation was performed in 23.3%. Kaplan Meier estimates of primary patency were 79.2% and 53.7% for all lesions at 1 and 2 years, respectively, whereas freedom from TLR was 85.4% and 68.6%. Primary patency for in-stent restenosis treatment was 76.6% and 48.6%, and freedom from TLR was 83.0% and 58.7% at 1 and 2 years, respectively. Rutherford category improved from a median 3.3 to 1.2 at 1 year, and to 1.1 at 2 years. Major amputation rate was 2.1% at 2 years. No adverse events were thought to be attributable to the coating of the balloon. Conclusions These results suggest that DCB are safe and effective in delaying rather than preventing restenosis in long, complex lesions and restenosis of the femoropopliteal tract. Further studies are recommended to confirm these results. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloons for Complex Femoropopliteal Lesions 2-Year Results of a Real-World Registry ###Abstract: Objectives The authors sought to investigate the efficacy of a drug-coated balloon (DCB) for treatment of complex femoropopliteal lesions. Background Superiority of DCBs compared with uncoated balloon angioplasty for femoropopliteal interventions has been demonstrated in randomized trials for short lesions. Their performance in complex lesions with higher restenosis rates is unclear. Methods Patency, target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints of femoropopliteal lesions in 288 limbs (n = 260) treated with the In.Pact Pacific or Admiral DCB (Medtronic, Minneapolis, Minnesota) were retrospectively analyzed for up to 2 years of follow-up. Predictors of restenosis were identified by logistic regression. Results Lesions were de novo in 51.7%, restenosis in 11.1%, and in-stent restenosis in 37.2%. Mean lesion length was 24.0 ± 10.2 cm, and 65.3% were occluded. Stent implantation was performed in 23.3%. Kaplan Meier estimates of primary patency were 79.2% and 53.7% for all lesions at 1 and 2 years, respectively, whereas freedom from TLR was 85.4% and 68.6%. Primary patency for in-stent restenosis treatment was 76.6% and 48.6%, and freedom from TLR was 83.0% and 58.7% at 1 and 2 years, respectively. Rutherford category improved from a median 3.3 to 1.2 at 1 year, and to 1.1 at 2 years. Major amputation rate was 2.1% at 2 years. No adverse events were thought to be attributable to the coating of the balloon. Conclusions These results suggest that DCB are safe and effective in delaying rather than preventing restenosis in long, complex lesions and restenosis of the femoropopliteal tract. Further studies are recommended to confirm these results. [/INST] Include </s>
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Schneider 2018
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Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial
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Background - Randomized controlled trials have reported favorable 1-year outcomes with drug-coated balloons (DCBs) for the treatment of symptomatic peripheral arterial disease when compared with standard percutaneous transluminal angioplasty (PTA). Evidence remains limited on the durability of the treatment effect with DCBs in the longer term. Methods and Results - IN.PACT SFA is a single-blind, randomized trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) that enrolled 331 patients with symptomatic (Rutherford 2-4) femoropopliteal lesions up to 18 cm in length. Patients were randomized 2:1 to receive treatment with DCB or PTA. The 36-month assessments included primary patency, freedom from clinically driven target lesion revascularization, major adverse events, and functional outcomes. At 36 months, primary patency remained significantly higher among patients treated with DCB compared with PTA (69.5% versus 45.1%; log rank P<0.001). The rates of clinically driven target lesion revascularization were 15.2% and 31.1% (P=0.002) for the DCB and PTA groups, respectively. Functional outcomes were similarly improved between treatment groups even though subjects in the DCB group required significantly fewer reinterventions versus those in the PTA group (P<0.001 for target lesion revascularization, P=0.001 for target vessel revascularization). There were no device- or procedure-related deaths as adjudicated by an independent Clinical Events Committee. Conclusions - Three-year results demonstrate a durable and superior treatment effect among patients treated with DCB versus standard PTA, with significantly higher primary patency and lower clinically driven target lesion revascularization, resulting in similar functional improvements with reduced need for repeat interventions. Clinical Trial Registration - URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01175850 for IN.PACT SFA phase I in the European Union and NCT01566461 for IN.PACT SFA phase II in the United States.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial ###Abstract: Background - Randomized controlled trials have reported favorable 1-year outcomes with drug-coated balloons (DCBs) for the treatment of symptomatic peripheral arterial disease when compared with standard percutaneous transluminal angioplasty (PTA). Evidence remains limited on the durability of the treatment effect with DCBs in the longer term. Methods and Results - IN.PACT SFA is a single-blind, randomized trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) that enrolled 331 patients with symptomatic (Rutherford 2-4) femoropopliteal lesions up to 18 cm in length. Patients were randomized 2:1 to receive treatment with DCB or PTA. The 36-month assessments included primary patency, freedom from clinically driven target lesion revascularization, major adverse events, and functional outcomes. At 36 months, primary patency remained significantly higher among patients treated with DCB compared with PTA (69.5% versus 45.1%; log rank P<0.001). The rates of clinically driven target lesion revascularization were 15.2% and 31.1% (P=0.002) for the DCB and PTA groups, respectively. Functional outcomes were similarly improved between treatment groups even though subjects in the DCB group required significantly fewer reinterventions versus those in the PTA group (P<0.001 for target lesion revascularization, P=0.001 for target vessel revascularization). There were no device- or procedure-related deaths as adjudicated by an independent Clinical Events Committee. Conclusions - Three-year results demonstrate a durable and superior treatment effect among patients treated with DCB versus standard PTA, with significantly higher primary patency and lower clinically driven target lesion revascularization, resulting in similar functional improvements with reduced need for repeat interventions. Clinical Trial Registration - URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01175850 for IN.PACT SFA phase I in the European Union and NCT01566461 for IN.PACT SFA phase II in the United States. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial ###Abstract: Background - Randomized controlled trials have reported favorable 1-year outcomes with drug-coated balloons (DCBs) for the treatment of symptomatic peripheral arterial disease when compared with standard percutaneous transluminal angioplasty (PTA). Evidence remains limited on the durability of the treatment effect with DCBs in the longer term. Methods and Results - IN.PACT SFA is a single-blind, randomized trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) that enrolled 331 patients with symptomatic (Rutherford 2-4) femoropopliteal lesions up to 18 cm in length. Patients were randomized 2:1 to receive treatment with DCB or PTA. The 36-month assessments included primary patency, freedom from clinically driven target lesion revascularization, major adverse events, and functional outcomes. At 36 months, primary patency remained significantly higher among patients treated with DCB compared with PTA (69.5% versus 45.1%; log rank P<0.001). The rates of clinically driven target lesion revascularization were 15.2% and 31.1% (P=0.002) for the DCB and PTA groups, respectively. Functional outcomes were similarly improved between treatment groups even though subjects in the DCB group required significantly fewer reinterventions versus those in the PTA group (P<0.001 for target lesion revascularization, P=0.001 for target vessel revascularization). There were no device- or procedure-related deaths as adjudicated by an independent Clinical Events Committee. Conclusions - Three-year results demonstrate a durable and superior treatment effect among patients treated with DCB versus standard PTA, with significantly higher primary patency and lower clinically driven target lesion revascularization, resulting in similar functional improvements with reduced need for repeat interventions. Clinical Trial Registration - URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01175850 for IN.PACT SFA phase I in the European Union and NCT01566461 for IN.PACT SFA phase II in the United States. [/INST] Include </s>
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Schneider 2019
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Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon
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Background: Five years of prospective clinical trials confirm that the paclitaxel drug-coated balloon (DCB) (IN.PACT Admiral, Medtronic, Dublin, Ireland) is safe and effective to treat femoropopliteal artery disease. A recent meta-analysis of heterogeneous trials of paclitaxel-based balloons and stents reported that they are associated with increased mortality and that higher doses are linked to higher mortality from 2 to 5 years. Objectives: The purpose of this study was to determine if there is a correlation between paclitaxel exposure and mortality by conducting an independent patient-level meta-analysis of 1,980 patients with up to 5-year follow-up. Methods: Data from 2 single-arm and 2 randomized independently adjudicated prospective studies of a paclitaxel DCB (n = 1,837) and uncoated percutaneous transluminal angioplasty (PTA) (n = 143) were included. Analyses of baseline, procedure, and follow-up data of individual patients were performed to explore correlations of paclitaxel dose with long-term mortality. Survival time by paclitaxel dose tercile was analyzed with adjustment of inverse probability weighting to correct baseline imbalances and study as random effect. A standard cohort was defined to compare DCB- and PTA-treated patients with similar characteristics by applying criteria from pivotal studies (n = 712 DCB, n = 143 PTA). Results: A survival analysis stratified nominal paclitaxel dose by low, mid, and upper terciles; mean doses were 5,019.0, 10,007.5, and 19,978.2 μg, respectively. Rates of freedom from all-cause mortality between the 3 groups through 5 years were 85.8%, 84.2%, and 88.2%, respectively (p = 0.731). There was no significant difference in all-cause mortality between DCB and PTA through 5 years comparing all patients (unadjusted p = 0.092) or patients with similar characteristics (adjusted p = 0.188). Conclusions: This independent patient-level meta-analysis demonstrates that this paclitaxel DCB is safe. Within DCB patients, there was no correlation between level of paclitaxel exposure and mortality. (Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I], NCT01175850; IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II], NCT01566461; MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery [MDT-2113 SFA], NCT01947478; The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population, NCT02118532; and IN.PACT Global Clinical Study, NCT01609296)
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon ###Abstract: Background: Five years of prospective clinical trials confirm that the paclitaxel drug-coated balloon (DCB) (IN.PACT Admiral, Medtronic, Dublin, Ireland) is safe and effective to treat femoropopliteal artery disease. A recent meta-analysis of heterogeneous trials of paclitaxel-based balloons and stents reported that they are associated with increased mortality and that higher doses are linked to higher mortality from 2 to 5 years. Objectives: The purpose of this study was to determine if there is a correlation between paclitaxel exposure and mortality by conducting an independent patient-level meta-analysis of 1,980 patients with up to 5-year follow-up. Methods: Data from 2 single-arm and 2 randomized independently adjudicated prospective studies of a paclitaxel DCB (n = 1,837) and uncoated percutaneous transluminal angioplasty (PTA) (n = 143) were included. Analyses of baseline, procedure, and follow-up data of individual patients were performed to explore correlations of paclitaxel dose with long-term mortality. Survival time by paclitaxel dose tercile was analyzed with adjustment of inverse probability weighting to correct baseline imbalances and study as random effect. A standard cohort was defined to compare DCB- and PTA-treated patients with similar characteristics by applying criteria from pivotal studies (n = 712 DCB, n = 143 PTA). Results: A survival analysis stratified nominal paclitaxel dose by low, mid, and upper terciles; mean doses were 5,019.0, 10,007.5, and 19,978.2 μg, respectively. Rates of freedom from all-cause mortality between the 3 groups through 5 years were 85.8%, 84.2%, and 88.2%, respectively (p = 0.731). There was no significant difference in all-cause mortality between DCB and PTA through 5 years comparing all patients (unadjusted p = 0.092) or patients with similar characteristics (adjusted p = 0.188). Conclusions: This independent patient-level meta-analysis demonstrates that this paclitaxel DCB is safe. Within DCB patients, there was no correlation between level of paclitaxel exposure and mortality. (Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I], NCT01175850; IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II], NCT01566461; MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery [MDT-2113 SFA], NCT01947478; The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population, NCT02118532; and IN.PACT Global Clinical Study, NCT01609296) [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon ###Abstract: Background: Five years of prospective clinical trials confirm that the paclitaxel drug-coated balloon (DCB) (IN.PACT Admiral, Medtronic, Dublin, Ireland) is safe and effective to treat femoropopliteal artery disease. A recent meta-analysis of heterogeneous trials of paclitaxel-based balloons and stents reported that they are associated with increased mortality and that higher doses are linked to higher mortality from 2 to 5 years. Objectives: The purpose of this study was to determine if there is a correlation between paclitaxel exposure and mortality by conducting an independent patient-level meta-analysis of 1,980 patients with up to 5-year follow-up. Methods: Data from 2 single-arm and 2 randomized independently adjudicated prospective studies of a paclitaxel DCB (n = 1,837) and uncoated percutaneous transluminal angioplasty (PTA) (n = 143) were included. Analyses of baseline, procedure, and follow-up data of individual patients were performed to explore correlations of paclitaxel dose with long-term mortality. Survival time by paclitaxel dose tercile was analyzed with adjustment of inverse probability weighting to correct baseline imbalances and study as random effect. A standard cohort was defined to compare DCB- and PTA-treated patients with similar characteristics by applying criteria from pivotal studies (n = 712 DCB, n = 143 PTA). Results: A survival analysis stratified nominal paclitaxel dose by low, mid, and upper terciles; mean doses were 5,019.0, 10,007.5, and 19,978.2 μg, respectively. Rates of freedom from all-cause mortality between the 3 groups through 5 years were 85.8%, 84.2%, and 88.2%, respectively (p = 0.731). There was no significant difference in all-cause mortality between DCB and PTA through 5 years comparing all patients (unadjusted p = 0.092) or patients with similar characteristics (adjusted p = 0.188). Conclusions: This independent patient-level meta-analysis demonstrates that this paclitaxel DCB is safe. Within DCB patients, there was no correlation between level of paclitaxel exposure and mortality. (Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I], NCT01175850; IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II], NCT01566461; MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery [MDT-2113 SFA], NCT01947478; The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population, NCT02118532; and IN.PACT Global Clinical Study, NCT01609296) [/INST] Include </s>
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Schneider 2020
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Paclitaxel exposure: Long-term safety and effectiveness of a drug-coated balloon for claudication in pooled randomized trials
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Background: Paclitaxel drug-coated balloons (DCB) prevent recurrent claudication after angioplasty, yet data from randomized trials with incomplete follow-up have raised uncertainty regarding long-term mortality. Objectives: To evaluate the effect of paclitaxel exposure on the long-term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials. Methods: The IN.PACT randomized trials (SFA, N = 331 and Japan, N = 100) each compared the DCB with standard percutaneous transluminal angioplasty (PTA) for claudication, and consented patients for 5 and 3 years, respectively. To address long-term safety, sites were requested to obtain vital status follow-up. In the pooled, updated data set, we examined the association between randomized treatment and mortality by cumulative incidence and hazard ratio (HR), and freedom from clinically driven target lesion revascularization (CD-TLR). Multivariable Cox regression with adjustment for baseline characteristics was used to evaluate the dose effect. Causes of death were adjudicated by a blinded clinical events committee that included oncologists with paclitaxel expertise. Results: The rate of long-term vital status ascertainment increased from 81% to 97% for DCB and from 85% to 97% for PTA in the IN.PACT SFA trial. The cumulative incidence of mortality was 14.7% DCB versus 12.0% PTA at 5 years, HR 1.39, log-rank p =.286. Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p =.381), but was an independent predictor of reduced risk of CD-TLR (HR 0.79; p <.001). Causes of death did not differ by treatment arm. Conclusions: In pooled randomized trial data with updated vital status ascertainment, paclitaxel was associated with improved efficacy but was not associated with increased mortality.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel exposure: Long-term safety and effectiveness of a drug-coated balloon for claudication in pooled randomized trials ###Abstract: Background: Paclitaxel drug-coated balloons (DCB) prevent recurrent claudication after angioplasty, yet data from randomized trials with incomplete follow-up have raised uncertainty regarding long-term mortality. Objectives: To evaluate the effect of paclitaxel exposure on the long-term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials. Methods: The IN.PACT randomized trials (SFA, N = 331 and Japan, N = 100) each compared the DCB with standard percutaneous transluminal angioplasty (PTA) for claudication, and consented patients for 5 and 3 years, respectively. To address long-term safety, sites were requested to obtain vital status follow-up. In the pooled, updated data set, we examined the association between randomized treatment and mortality by cumulative incidence and hazard ratio (HR), and freedom from clinically driven target lesion revascularization (CD-TLR). Multivariable Cox regression with adjustment for baseline characteristics was used to evaluate the dose effect. Causes of death were adjudicated by a blinded clinical events committee that included oncologists with paclitaxel expertise. Results: The rate of long-term vital status ascertainment increased from 81% to 97% for DCB and from 85% to 97% for PTA in the IN.PACT SFA trial. The cumulative incidence of mortality was 14.7% DCB versus 12.0% PTA at 5 years, HR 1.39, log-rank p =.286. Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p =.381), but was an independent predictor of reduced risk of CD-TLR (HR 0.79; p <.001). Causes of death did not differ by treatment arm. Conclusions: In pooled randomized trial data with updated vital status ascertainment, paclitaxel was associated with improved efficacy but was not associated with increased mortality. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel exposure: Long-term safety and effectiveness of a drug-coated balloon for claudication in pooled randomized trials ###Abstract: Background: Paclitaxel drug-coated balloons (DCB) prevent recurrent claudication after angioplasty, yet data from randomized trials with incomplete follow-up have raised uncertainty regarding long-term mortality. Objectives: To evaluate the effect of paclitaxel exposure on the long-term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials. Methods: The IN.PACT randomized trials (SFA, N = 331 and Japan, N = 100) each compared the DCB with standard percutaneous transluminal angioplasty (PTA) for claudication, and consented patients for 5 and 3 years, respectively. To address long-term safety, sites were requested to obtain vital status follow-up. In the pooled, updated data set, we examined the association between randomized treatment and mortality by cumulative incidence and hazard ratio (HR), and freedom from clinically driven target lesion revascularization (CD-TLR). Multivariable Cox regression with adjustment for baseline characteristics was used to evaluate the dose effect. Causes of death were adjudicated by a blinded clinical events committee that included oncologists with paclitaxel expertise. Results: The rate of long-term vital status ascertainment increased from 81% to 97% for DCB and from 85% to 97% for PTA in the IN.PACT SFA trial. The cumulative incidence of mortality was 14.7% DCB versus 12.0% PTA at 5 years, HR 1.39, log-rank p =.286. Paclitaxel dose (mg) was not an independent predictor of mortality (HR 1.02, p =.381), but was an independent predictor of reduced risk of CD-TLR (HR 0.79; p <.001). Causes of death did not differ by treatment arm. Conclusions: In pooled randomized trial data with updated vital status ascertainment, paclitaxel was associated with improved efficacy but was not associated with increased mortality. [/INST] Include </s>
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Shishehbor 2019
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Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts
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Objective: Randomized controlled trials have shown that drug-coated balloons (DCBs) provide superior results compared with percutaneous transluminal angioplasty (PTA) for the treatment of femoropopliteal artery disease. However, these trials have generally included short lesions, few occlusions, and small sample sizes. The present study was an individual-level pooled analysis of duplex ultrasonography (DUS) core laboratory-adjudicated and clinical events committee-adjudicated IN.PACT Admiral DCB subjects across two randomized controlled trials and two single-arm prospective studies to characterize the safety and effectiveness of DCB compared with PTA. Methods: The subjects were treated with DCB (n = 926) or PTA (n = 143). The end points through 12 months included DUS core laboratory-adjudicated primary patency and clinically driven target lesion revascularization (CD-TLR) using Kaplan-Meier estimates and primary safety using proportions. A propensity-matched analysis of DCB (n = 466) to PTA (n = 136) was conducted to address confounders. Results: At 12 months, DCB compared with PTA had significantly greater primary patency (88.8% vs 53.9%; P < .001), freedom from CD-TLR (94.3% vs 80.2%; P < .001), and better primary safety composite end point (94.1% vs 78.0%; P < .001). After propensity-matched analysis, DCB remained superior to PTA at 12 months for primary patency (90.5% vs 53.8%; P < .001), freedom from CD-TLR (96.9% vs 80.7%; P < .001), and the primary safety composite end point (96.3% vs 78.4%; P < .001). Across multiple prespecified subgroup analyses, including provisional stenting, DCB remained persistently superior to PTA. Conclusions: In the largest, DUS core laboratory-adjudicated, multiethnic, pooled DCB series to date, the IN.PACT Admiral DCB demonstrated significantly greater primary patency, freedom from CD-TLR, and better composite safety at 12 months compared with PTA.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts ###Abstract: Objective: Randomized controlled trials have shown that drug-coated balloons (DCBs) provide superior results compared with percutaneous transluminal angioplasty (PTA) for the treatment of femoropopliteal artery disease. However, these trials have generally included short lesions, few occlusions, and small sample sizes. The present study was an individual-level pooled analysis of duplex ultrasonography (DUS) core laboratory-adjudicated and clinical events committee-adjudicated IN.PACT Admiral DCB subjects across two randomized controlled trials and two single-arm prospective studies to characterize the safety and effectiveness of DCB compared with PTA. Methods: The subjects were treated with DCB (n = 926) or PTA (n = 143). The end points through 12 months included DUS core laboratory-adjudicated primary patency and clinically driven target lesion revascularization (CD-TLR) using Kaplan-Meier estimates and primary safety using proportions. A propensity-matched analysis of DCB (n = 466) to PTA (n = 136) was conducted to address confounders. Results: At 12 months, DCB compared with PTA had significantly greater primary patency (88.8% vs 53.9%; P < .001), freedom from CD-TLR (94.3% vs 80.2%; P < .001), and better primary safety composite end point (94.1% vs 78.0%; P < .001). After propensity-matched analysis, DCB remained superior to PTA at 12 months for primary patency (90.5% vs 53.8%; P < .001), freedom from CD-TLR (96.9% vs 80.7%; P < .001), and the primary safety composite end point (96.3% vs 78.4%; P < .001). Across multiple prespecified subgroup analyses, including provisional stenting, DCB remained persistently superior to PTA. Conclusions: In the largest, DUS core laboratory-adjudicated, multiethnic, pooled DCB series to date, the IN.PACT Admiral DCB demonstrated significantly greater primary patency, freedom from CD-TLR, and better composite safety at 12 months compared with PTA. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts ###Abstract: Objective: Randomized controlled trials have shown that drug-coated balloons (DCBs) provide superior results compared with percutaneous transluminal angioplasty (PTA) for the treatment of femoropopliteal artery disease. However, these trials have generally included short lesions, few occlusions, and small sample sizes. The present study was an individual-level pooled analysis of duplex ultrasonography (DUS) core laboratory-adjudicated and clinical events committee-adjudicated IN.PACT Admiral DCB subjects across two randomized controlled trials and two single-arm prospective studies to characterize the safety and effectiveness of DCB compared with PTA. Methods: The subjects were treated with DCB (n = 926) or PTA (n = 143). The end points through 12 months included DUS core laboratory-adjudicated primary patency and clinically driven target lesion revascularization (CD-TLR) using Kaplan-Meier estimates and primary safety using proportions. A propensity-matched analysis of DCB (n = 466) to PTA (n = 136) was conducted to address confounders. Results: At 12 months, DCB compared with PTA had significantly greater primary patency (88.8% vs 53.9%; P < .001), freedom from CD-TLR (94.3% vs 80.2%; P < .001), and better primary safety composite end point (94.1% vs 78.0%; P < .001). After propensity-matched analysis, DCB remained superior to PTA at 12 months for primary patency (90.5% vs 53.8%; P < .001), freedom from CD-TLR (96.9% vs 80.7%; P < .001), and the primary safety composite end point (96.3% vs 78.4%; P < .001). Across multiple prespecified subgroup analyses, including provisional stenting, DCB remained persistently superior to PTA. Conclusions: In the largest, DUS core laboratory-adjudicated, multiethnic, pooled DCB series to date, the IN.PACT Admiral DCB demonstrated significantly greater primary patency, freedom from CD-TLR, and better composite safety at 12 months compared with PTA. [/INST] Include </s>
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Soga 2020
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Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty
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Purpose: To evaluate the 3-year safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA) in a Japanese population with femoropopliteal occlusive disease. Materials and Methods: The multicenter, prospective, IN.PACT SFA Japan randomized controlled trial (ClinicalTrials.gov identifier NCT01947478) was an independently adjudicated study evaluating Japanese participants randomized 2:1 to DCB (n=68) or PTA (n=32). The effectiveness endpoint was primary patency through 36 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis (by duplex ultrasound). The effectiveness endpoint was evaluated using the Kaplan-Meier method; estimates are presented with the 95% confidence intervals (CIs). The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 36 months. Results: Primary patency by Kaplan-Meier estimate was higher in the DCB group (68.9%, 95% CI 57.5% to 80.2%) vs the PTA group (46.9%, 95% CI 29.6% to 64.2%) at 36 months (log-rank p=0.001). The CD-TLR rates were 14.9% (10/67) for the DCB group and 20.7% (6/29) for PTA (p=0.554). The safety composite endpoint occurred in 83.6% (56/67) of DCB participants and 75.9% (22/29) of PTA participants (p=0.402). All-cause death was similar between groups at 36 months [DCB 6.0% (4/67) vs PTA 6.9% (2/29), p>0.999), with no device- or procedure-related deaths in either group. Conclusion: The final report of the IN.PACT SFA Japan trial showed that the IN.PACT Admiral DCB is safe and had durable outcomes through 3 years in Japanese participants with femoropopliteal occlusive disease.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty ###Abstract: Purpose: To evaluate the 3-year safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA) in a Japanese population with femoropopliteal occlusive disease. Materials and Methods: The multicenter, prospective, IN.PACT SFA Japan randomized controlled trial (ClinicalTrials.gov identifier NCT01947478) was an independently adjudicated study evaluating Japanese participants randomized 2:1 to DCB (n=68) or PTA (n=32). The effectiveness endpoint was primary patency through 36 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis (by duplex ultrasound). The effectiveness endpoint was evaluated using the Kaplan-Meier method; estimates are presented with the 95% confidence intervals (CIs). The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 36 months. Results: Primary patency by Kaplan-Meier estimate was higher in the DCB group (68.9%, 95% CI 57.5% to 80.2%) vs the PTA group (46.9%, 95% CI 29.6% to 64.2%) at 36 months (log-rank p=0.001). The CD-TLR rates were 14.9% (10/67) for the DCB group and 20.7% (6/29) for PTA (p=0.554). The safety composite endpoint occurred in 83.6% (56/67) of DCB participants and 75.9% (22/29) of PTA participants (p=0.402). All-cause death was similar between groups at 36 months [DCB 6.0% (4/67) vs PTA 6.9% (2/29), p>0.999), with no device- or procedure-related deaths in either group. Conclusion: The final report of the IN.PACT SFA Japan trial showed that the IN.PACT Admiral DCB is safe and had durable outcomes through 3 years in Japanese participants with femoropopliteal occlusive disease. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty ###Abstract: Purpose: To evaluate the 3-year safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA) in a Japanese population with femoropopliteal occlusive disease. Materials and Methods: The multicenter, prospective, IN.PACT SFA Japan randomized controlled trial (ClinicalTrials.gov identifier NCT01947478) was an independently adjudicated study evaluating Japanese participants randomized 2:1 to DCB (n=68) or PTA (n=32). The effectiveness endpoint was primary patency through 36 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis (by duplex ultrasound). The effectiveness endpoint was evaluated using the Kaplan-Meier method; estimates are presented with the 95% confidence intervals (CIs). The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 36 months. Results: Primary patency by Kaplan-Meier estimate was higher in the DCB group (68.9%, 95% CI 57.5% to 80.2%) vs the PTA group (46.9%, 95% CI 29.6% to 64.2%) at 36 months (log-rank p=0.001). The CD-TLR rates were 14.9% (10/67) for the DCB group and 20.7% (6/29) for PTA (p=0.554). The safety composite endpoint occurred in 83.6% (56/67) of DCB participants and 75.9% (22/29) of PTA participants (p=0.402). All-cause death was similar between groups at 36 months [DCB 6.0% (4/67) vs PTA 6.9% (2/29), p>0.999), with no device- or procedure-related deaths in either group. Conclusion: The final report of the IN.PACT SFA Japan trial showed that the IN.PACT Admiral DCB is safe and had durable outcomes through 3 years in Japanese participants with femoropopliteal occlusive disease. [/INST] Include </s>
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Stahlhoff 2015
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Drug-eluting vs standard balloon angioplasty for iliac stent restenosis: Midterm results
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Purpose: To assess the effectiveness of drug-eluting balloon (DEB) angioplasty for the treatment of iliac artery in-stent restenosis (ISR). Methods: Data from 18 patients (mean age 59.3±9.6 years; 11 men) treated with DEB for iliac ISR between October 2009 and August 2013 were retrospectively evaluated and compared with a control group of 22 patients (mean age 66.7±11.8 years; 16 men) treated with standard balloon angioplasty (BA). Primary endpoint of the study was the primary patency rate at 12 months. Secondary endpoints were 30-day and overall mortality, sustained clinical improvement [ankle-brachial index (ABI) and Rutherford category] and clinically driven target lesion revascularization (TLR). Followup examinations were performed by clinical examination, color duplex ultrasound, and ABI measurement at 12 months. Results: Mean length of the 21 lesions in the DEB group was 27.1±19.2 mm vs 20.0±11.4 mm for the 25 lesions in the BA group (p=0.508), while the grade of restenosis was 70.4%±18.4% and 64.0%±16.1% (p=0.255), respectively. Primary patency rates were 90.5% vs 85.7% at 6 months and 71.4% vs 75.6% at 12 months for DEB and BA, respectively (p=0.784). Five BA patients died during follow-up for reasons unrelated to the procedure, while no patient in the DEB group died (p=0.035). In both groups, Rutherford category and ABI significantly improved compared to pretreatment levels; there were no differences between the groups regarding these variables (p=0.367 and p=0.898, respectively). The TLR rate was 28.6% (6/21) in the DEB group and 20.0% (4/20) in the BA cohort (p=0.434). Conclusion: Treatment of iliac ISR using DEBs is a safe procedure, with results comparable to BA treatment. Because of the limited number of patients in this study, further investigation of a larger cohort with longer follow-up is needed to define the role of DEBs in the treatment of iliac ISR.
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Include
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DI2 - Off Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-eluting vs standard balloon angioplasty for iliac stent restenosis: Midterm results ###Abstract: Purpose: To assess the effectiveness of drug-eluting balloon (DEB) angioplasty for the treatment of iliac artery in-stent restenosis (ISR). Methods: Data from 18 patients (mean age 59.3±9.6 years; 11 men) treated with DEB for iliac ISR between October 2009 and August 2013 were retrospectively evaluated and compared with a control group of 22 patients (mean age 66.7±11.8 years; 16 men) treated with standard balloon angioplasty (BA). Primary endpoint of the study was the primary patency rate at 12 months. Secondary endpoints were 30-day and overall mortality, sustained clinical improvement [ankle-brachial index (ABI) and Rutherford category] and clinically driven target lesion revascularization (TLR). Followup examinations were performed by clinical examination, color duplex ultrasound, and ABI measurement at 12 months. Results: Mean length of the 21 lesions in the DEB group was 27.1±19.2 mm vs 20.0±11.4 mm for the 25 lesions in the BA group (p=0.508), while the grade of restenosis was 70.4%±18.4% and 64.0%±16.1% (p=0.255), respectively. Primary patency rates were 90.5% vs 85.7% at 6 months and 71.4% vs 75.6% at 12 months for DEB and BA, respectively (p=0.784). Five BA patients died during follow-up for reasons unrelated to the procedure, while no patient in the DEB group died (p=0.035). In both groups, Rutherford category and ABI significantly improved compared to pretreatment levels; there were no differences between the groups regarding these variables (p=0.367 and p=0.898, respectively). The TLR rate was 28.6% (6/21) in the DEB group and 20.0% (4/20) in the BA cohort (p=0.434). Conclusion: Treatment of iliac ISR using DEBs is a safe procedure, with results comparable to BA treatment. Because of the limited number of patients in this study, further investigation of a larger cohort with longer follow-up is needed to define the role of DEBs in the treatment of iliac ISR. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-eluting vs standard balloon angioplasty for iliac stent restenosis: Midterm results ###Abstract: Purpose: To assess the effectiveness of drug-eluting balloon (DEB) angioplasty for the treatment of iliac artery in-stent restenosis (ISR). Methods: Data from 18 patients (mean age 59.3±9.6 years; 11 men) treated with DEB for iliac ISR between October 2009 and August 2013 were retrospectively evaluated and compared with a control group of 22 patients (mean age 66.7±11.8 years; 16 men) treated with standard balloon angioplasty (BA). Primary endpoint of the study was the primary patency rate at 12 months. Secondary endpoints were 30-day and overall mortality, sustained clinical improvement [ankle-brachial index (ABI) and Rutherford category] and clinically driven target lesion revascularization (TLR). Followup examinations were performed by clinical examination, color duplex ultrasound, and ABI measurement at 12 months. Results: Mean length of the 21 lesions in the DEB group was 27.1±19.2 mm vs 20.0±11.4 mm for the 25 lesions in the BA group (p=0.508), while the grade of restenosis was 70.4%±18.4% and 64.0%±16.1% (p=0.255), respectively. Primary patency rates were 90.5% vs 85.7% at 6 months and 71.4% vs 75.6% at 12 months for DEB and BA, respectively (p=0.784). Five BA patients died during follow-up for reasons unrelated to the procedure, while no patient in the DEB group died (p=0.035). In both groups, Rutherford category and ABI significantly improved compared to pretreatment levels; there were no differences between the groups regarding these variables (p=0.367 and p=0.898, respectively). The TLR rate was 28.6% (6/21) in the DEB group and 20.0% (4/20) in the BA cohort (p=0.434). Conclusion: Treatment of iliac ISR using DEBs is a safe procedure, with results comparable to BA treatment. Because of the limited number of patients in this study, further investigation of a larger cohort with longer follow-up is needed to define the role of DEBs in the treatment of iliac ISR. [/INST] Include </s>
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Stavroulakis 2017
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Directional atherectomy with antirestenotic therapy vs drug-coated balloon angioplasty alone for isolated popliteal artery lesions
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Purpose: To report a single-center study comparing drug-coated balloon (DCB) angioplasty vs directional atherectomy with antirestenotic therapy (DAART) for isolated lesions of the popliteal artery. Methods: Seventy-two patients were treated with either DCB angioplasty alone (n=31) or with DAART (n=41) for isolated popliteal artery stenotic disease between October 2009 and December 2015. The majority of patients presented with lifestyle-limiting claudication (74% vs 86%, respectively). Vessel calcification (29% vs 29%, respectively), mean lesion length (47 vs 42 mm, respectively), and number of runoff vessels were comparable between the groups. The primary outcome measure was primary patency; secondary outcomes were technical success (<30% residual stenosis or bailout stenting), secondary patency, and freedom from clinically driven target lesion revascularization (TLR). Results: The technical success rate following DCB was 84% vs 93% (p=0.24) after DAART. The 12-month primary patency rate was significantly higher in the DAART group (65% vs 82%; hazard ratio 2.64, 95% confidence interval 1.09 to 6.37, p=0.021), while freedom from TLR did not differ between the 2 treatment strategies (82% vs 94%, p=0.072). Secondary patency at 12 months was identical for both groups (96% vs 96%). Although not statistically significant, bailout stenting was more common after DCB angioplasty (16% vs 5% for DAART, p=0.13) and aneurysmal degeneration of the popliteal artery was seen more often after DAART (7% vs 0% for DCB alone, p=0.25). Popliteal artery injury was observed in 2 patients treated using DAART (5% vs 0% for DCB alone, p=0.5), whereas distal embolization rates were comparable between the groups (3% for DCB alone vs 5% for DAART, p=0.99). Conclusion: In this study, the use of DAART was associated with a higher primary patency rate compared with DCB angioplasty for isolated popliteal lesions. Nonetheless, both treatment options were associated with excellent 12-month secondary patency. Aneurysmal degeneration of the popliteal artery and increased bailout stenting could compromise the outcomes of DAART and DCB, respectively.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Directional atherectomy with antirestenotic therapy vs drug-coated balloon angioplasty alone for isolated popliteal artery lesions ###Abstract: Purpose: To report a single-center study comparing drug-coated balloon (DCB) angioplasty vs directional atherectomy with antirestenotic therapy (DAART) for isolated lesions of the popliteal artery. Methods: Seventy-two patients were treated with either DCB angioplasty alone (n=31) or with DAART (n=41) for isolated popliteal artery stenotic disease between October 2009 and December 2015. The majority of patients presented with lifestyle-limiting claudication (74% vs 86%, respectively). Vessel calcification (29% vs 29%, respectively), mean lesion length (47 vs 42 mm, respectively), and number of runoff vessels were comparable between the groups. The primary outcome measure was primary patency; secondary outcomes were technical success (<30% residual stenosis or bailout stenting), secondary patency, and freedom from clinically driven target lesion revascularization (TLR). Results: The technical success rate following DCB was 84% vs 93% (p=0.24) after DAART. The 12-month primary patency rate was significantly higher in the DAART group (65% vs 82%; hazard ratio 2.64, 95% confidence interval 1.09 to 6.37, p=0.021), while freedom from TLR did not differ between the 2 treatment strategies (82% vs 94%, p=0.072). Secondary patency at 12 months was identical for both groups (96% vs 96%). Although not statistically significant, bailout stenting was more common after DCB angioplasty (16% vs 5% for DAART, p=0.13) and aneurysmal degeneration of the popliteal artery was seen more often after DAART (7% vs 0% for DCB alone, p=0.25). Popliteal artery injury was observed in 2 patients treated using DAART (5% vs 0% for DCB alone, p=0.5), whereas distal embolization rates were comparable between the groups (3% for DCB alone vs 5% for DAART, p=0.99). Conclusion: In this study, the use of DAART was associated with a higher primary patency rate compared with DCB angioplasty for isolated popliteal lesions. Nonetheless, both treatment options were associated with excellent 12-month secondary patency. Aneurysmal degeneration of the popliteal artery and increased bailout stenting could compromise the outcomes of DAART and DCB, respectively. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Directional atherectomy with antirestenotic therapy vs drug-coated balloon angioplasty alone for isolated popliteal artery lesions ###Abstract: Purpose: To report a single-center study comparing drug-coated balloon (DCB) angioplasty vs directional atherectomy with antirestenotic therapy (DAART) for isolated lesions of the popliteal artery. Methods: Seventy-two patients were treated with either DCB angioplasty alone (n=31) or with DAART (n=41) for isolated popliteal artery stenotic disease between October 2009 and December 2015. The majority of patients presented with lifestyle-limiting claudication (74% vs 86%, respectively). Vessel calcification (29% vs 29%, respectively), mean lesion length (47 vs 42 mm, respectively), and number of runoff vessels were comparable between the groups. The primary outcome measure was primary patency; secondary outcomes were technical success (<30% residual stenosis or bailout stenting), secondary patency, and freedom from clinically driven target lesion revascularization (TLR). Results: The technical success rate following DCB was 84% vs 93% (p=0.24) after DAART. The 12-month primary patency rate was significantly higher in the DAART group (65% vs 82%; hazard ratio 2.64, 95% confidence interval 1.09 to 6.37, p=0.021), while freedom from TLR did not differ between the 2 treatment strategies (82% vs 94%, p=0.072). Secondary patency at 12 months was identical for both groups (96% vs 96%). Although not statistically significant, bailout stenting was more common after DCB angioplasty (16% vs 5% for DAART, p=0.13) and aneurysmal degeneration of the popliteal artery was seen more often after DAART (7% vs 0% for DCB alone, p=0.25). Popliteal artery injury was observed in 2 patients treated using DAART (5% vs 0% for DCB alone, p=0.5), whereas distal embolization rates were comparable between the groups (3% for DCB alone vs 5% for DAART, p=0.99). Conclusion: In this study, the use of DAART was associated with a higher primary patency rate compared with DCB angioplasty for isolated popliteal lesions. Nonetheless, both treatment options were associated with excellent 12-month secondary patency. Aneurysmal degeneration of the popliteal artery and increased bailout stenting could compromise the outcomes of DAART and DCB, respectively. [/INST] Include </s>
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Stavroulakis 2018
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Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Common Femoral Artery Atherosclerotic Disease
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Purpose: To report an experience using directional atherectomy (DA) with antirestenotic therapy (DAART) in the form of drug-coated balloon (DCB) angioplasty vs DCB angioplasty alone in common femoral artery (CFA) occlusive lesions. Methods: A retrospective review was conducted of 47 consecutive patients (mean age 71 years; 26 men) treated between October 2011 and July 2016 using either DCB angioplasty alone (n=26) or DAART (n=21) for CFA lesions. The majority of patients had lifestyle-limiting claudication (14 DCB and 15 DAART). Mean lesion length (39±14 mm DCB and 34±16 mm DAART) and vessel calcification (17/26 DCB and 11/21 DAART) were comparable between the groups. There were 4 chronic total occlusions, all in the DAART group. The main outcome measure was primary patency. Key secondary outcomes were technical success, secondary patency, and freedom from clinically-driven target lesion revascularization (TLR). Results: Technical success rates were 89% following DCB angioplasty and 95% for DAART (p=0.41). The 88% 12-month primary patency and 89% freedom from TLR for DAART were higher than the 68% and 75% estimates following DCB angioplasty alone, but neither difference was statistically significant. However, the secondary patency estimate at 12 months was significantly higher in the DAART group (100% vs 81% for DCB, p=0.03). Bailout stenting (1 DCB vs 1 DAART), vessel perforation (1 DCB vs 0 DAART), access site complications (4 DCB vs 3 DAART), and distal embolization (0 DCB vs 1 DAART) were comparable, whereas DCB angioplasty had more non-flow-limiting dissections (8 vs 1 for DAART, p=0.02). Conclusion: Preparation of the atherosclerotic CFA with directional atherectomy was not associated with statistically significantly higher primary patency or freedom from TLR compared to DCB angioplasty alone at 12 months. Nonetheless, both modalities had promising outcomes in a primarily surgically treated vascular territory.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Common Femoral Artery Atherosclerotic Disease ###Abstract: Purpose: To report an experience using directional atherectomy (DA) with antirestenotic therapy (DAART) in the form of drug-coated balloon (DCB) angioplasty vs DCB angioplasty alone in common femoral artery (CFA) occlusive lesions. Methods: A retrospective review was conducted of 47 consecutive patients (mean age 71 years; 26 men) treated between October 2011 and July 2016 using either DCB angioplasty alone (n=26) or DAART (n=21) for CFA lesions. The majority of patients had lifestyle-limiting claudication (14 DCB and 15 DAART). Mean lesion length (39±14 mm DCB and 34±16 mm DAART) and vessel calcification (17/26 DCB and 11/21 DAART) were comparable between the groups. There were 4 chronic total occlusions, all in the DAART group. The main outcome measure was primary patency. Key secondary outcomes were technical success, secondary patency, and freedom from clinically-driven target lesion revascularization (TLR). Results: Technical success rates were 89% following DCB angioplasty and 95% for DAART (p=0.41). The 88% 12-month primary patency and 89% freedom from TLR for DAART were higher than the 68% and 75% estimates following DCB angioplasty alone, but neither difference was statistically significant. However, the secondary patency estimate at 12 months was significantly higher in the DAART group (100% vs 81% for DCB, p=0.03). Bailout stenting (1 DCB vs 1 DAART), vessel perforation (1 DCB vs 0 DAART), access site complications (4 DCB vs 3 DAART), and distal embolization (0 DCB vs 1 DAART) were comparable, whereas DCB angioplasty had more non-flow-limiting dissections (8 vs 1 for DAART, p=0.02). Conclusion: Preparation of the atherosclerotic CFA with directional atherectomy was not associated with statistically significantly higher primary patency or freedom from TLR compared to DCB angioplasty alone at 12 months. Nonetheless, both modalities had promising outcomes in a primarily surgically treated vascular territory. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Common Femoral Artery Atherosclerotic Disease ###Abstract: Purpose: To report an experience using directional atherectomy (DA) with antirestenotic therapy (DAART) in the form of drug-coated balloon (DCB) angioplasty vs DCB angioplasty alone in common femoral artery (CFA) occlusive lesions. Methods: A retrospective review was conducted of 47 consecutive patients (mean age 71 years; 26 men) treated between October 2011 and July 2016 using either DCB angioplasty alone (n=26) or DAART (n=21) for CFA lesions. The majority of patients had lifestyle-limiting claudication (14 DCB and 15 DAART). Mean lesion length (39±14 mm DCB and 34±16 mm DAART) and vessel calcification (17/26 DCB and 11/21 DAART) were comparable between the groups. There were 4 chronic total occlusions, all in the DAART group. The main outcome measure was primary patency. Key secondary outcomes were technical success, secondary patency, and freedom from clinically-driven target lesion revascularization (TLR). Results: Technical success rates were 89% following DCB angioplasty and 95% for DAART (p=0.41). The 88% 12-month primary patency and 89% freedom from TLR for DAART were higher than the 68% and 75% estimates following DCB angioplasty alone, but neither difference was statistically significant. However, the secondary patency estimate at 12 months was significantly higher in the DAART group (100% vs 81% for DCB, p=0.03). Bailout stenting (1 DCB vs 1 DAART), vessel perforation (1 DCB vs 0 DAART), access site complications (4 DCB vs 3 DAART), and distal embolization (0 DCB vs 1 DAART) were comparable, whereas DCB angioplasty had more non-flow-limiting dissections (8 vs 1 for DAART, p=0.02). Conclusion: Preparation of the atherosclerotic CFA with directional atherectomy was not associated with statistically significantly higher primary patency or freedom from TLR compared to DCB angioplasty alone at 12 months. Nonetheless, both modalities had promising outcomes in a primarily surgically treated vascular territory. [/INST] Include </s>
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Steiner 2020
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COMPARE: Prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions
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Aims Drug-coated balloons (DCBs) for femoropopliteal interventions have not been tested against each other. We aimed to directly compare efficacy and safety of a high-dose (In.Pact(TM)) vs. low-dose (Ranger(TM)) DCB with nominal paclitaxel densities of 3.5 vs. 2.0 lg/mm(2). Methods Within a prospective, multicentre, non-inferiority, clinical trial 414 patients with symptomatic femoropopliteal and results lesions (Rutherford classification 2-4) were randomly assigned in a 1:1 ratio to endovascular treatment with either high- or low-dose DCB after stratification for lesion length. Primary efficacy and safety endpoints comprised primary patency and freedom from major adverse events (i.e. device and procedure-related deaths through 1 month, major amputations, and clinically driven target lesion revascularization through 12 months). We set a non-inferiority margin of -10% at 12 months. Total occlusions were observed frequently (>40%) and provisional stenting was performed in every fourth intervention. Non-inferiority was determined for both primary efficacy and safety endpoints at 12 months. Primary patency was 81.5% in the high-dose and 83.0% in low-dose DCB group fdifference: 1.5% [lower bound of the 90% two-sided confidence interval (CI) -5.2%]; P(non-inferiority) < 0.01g. Freedom from major adverse events was determined in 92.6% in high-dose and in 91.0% in low-dose DCB group [difference -1.6% (lower bound of the 90% two-sided CI -6.5%); P(non-inferiority) < 0.01]. Overall death rate was low (2.0%) and no major amputation occurred. Conclusion Two DCBs with different coating characteristics exhibited comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions including a wide range of lesion lengths.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: COMPARE: Prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions ###Abstract: Aims Drug-coated balloons (DCBs) for femoropopliteal interventions have not been tested against each other. We aimed to directly compare efficacy and safety of a high-dose (In.Pact(TM)) vs. low-dose (Ranger(TM)) DCB with nominal paclitaxel densities of 3.5 vs. 2.0 lg/mm(2). Methods Within a prospective, multicentre, non-inferiority, clinical trial 414 patients with symptomatic femoropopliteal and results lesions (Rutherford classification 2-4) were randomly assigned in a 1:1 ratio to endovascular treatment with either high- or low-dose DCB after stratification for lesion length. Primary efficacy and safety endpoints comprised primary patency and freedom from major adverse events (i.e. device and procedure-related deaths through 1 month, major amputations, and clinically driven target lesion revascularization through 12 months). We set a non-inferiority margin of -10% at 12 months. Total occlusions were observed frequently (>40%) and provisional stenting was performed in every fourth intervention. Non-inferiority was determined for both primary efficacy and safety endpoints at 12 months. Primary patency was 81.5% in the high-dose and 83.0% in low-dose DCB group fdifference: 1.5% [lower bound of the 90% two-sided confidence interval (CI) -5.2%]; P(non-inferiority) < 0.01g. Freedom from major adverse events was determined in 92.6% in high-dose and in 91.0% in low-dose DCB group [difference -1.6% (lower bound of the 90% two-sided CI -6.5%); P(non-inferiority) < 0.01]. Overall death rate was low (2.0%) and no major amputation occurred. Conclusion Two DCBs with different coating characteristics exhibited comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions including a wide range of lesion lengths. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: COMPARE: Prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions ###Abstract: Aims Drug-coated balloons (DCBs) for femoropopliteal interventions have not been tested against each other. We aimed to directly compare efficacy and safety of a high-dose (In.Pact(TM)) vs. low-dose (Ranger(TM)) DCB with nominal paclitaxel densities of 3.5 vs. 2.0 lg/mm(2). Methods Within a prospective, multicentre, non-inferiority, clinical trial 414 patients with symptomatic femoropopliteal and results lesions (Rutherford classification 2-4) were randomly assigned in a 1:1 ratio to endovascular treatment with either high- or low-dose DCB after stratification for lesion length. Primary efficacy and safety endpoints comprised primary patency and freedom from major adverse events (i.e. device and procedure-related deaths through 1 month, major amputations, and clinically driven target lesion revascularization through 12 months). We set a non-inferiority margin of -10% at 12 months. Total occlusions were observed frequently (>40%) and provisional stenting was performed in every fourth intervention. Non-inferiority was determined for both primary efficacy and safety endpoints at 12 months. Primary patency was 81.5% in the high-dose and 83.0% in low-dose DCB group fdifference: 1.5% [lower bound of the 90% two-sided confidence interval (CI) -5.2%]; P(non-inferiority) < 0.01g. Freedom from major adverse events was determined in 92.6% in high-dose and in 91.0% in low-dose DCB group [difference -1.6% (lower bound of the 90% two-sided CI -6.5%); P(non-inferiority) < 0.01]. Overall death rate was low (2.0%) and no major amputation occurred. Conclusion Two DCBs with different coating characteristics exhibited comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions including a wide range of lesion lengths. [/INST] Include </s>
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Swinnen 2015
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Paclitaxel drug-eluting balloons to recurrent in-stent stenoses in autogenous dialysis fistulas: A retrospective study
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Purpose: To assess the effect of the Medtronic paclitaxel drug-eluting balloon (DEB) on re-intervention to in-stent stenoses in autogenous dialysis arteriovenous fistulas (AVFs). Background: AVF is the optimum haemodialysis access. The commonest problem is stenosis, preventing maturation, causing inadequate dialysis or precipitating occlusion. Conventional angioplasty has a high recurrence rate. Successful drug elution in the coronary circulation led us to use DEBs in recurrent AVF stenoses since 2010. Methods: This is a retrospective study, based on prospective audit data, using DEBs on recurrent in-stent stenotic lesions in the AVF circuit of our haemodialysis population. To analyse the effect of DEBs on re-intervention, we created two Kaplan–Meier curves. The first curve compares the last “disease-free-interval” pre-DEB intervention to the first “disease-free interval” post-DEB, giving us “re-intervention-free percentage at 12 months” pre- and post-DEB. The second curve takes into account the multiple pre- and post-DEB interventions to the index lesion, and uses a marginal proportional hazards model to estimate the hazard ratio for “DEBpresent vs. DEBabsent”. Results: From 1 September 2010 to 1 December 2013, we treated 625 AVF stenoses with endovascular techniques. In 86 of these stenoses, DEBs were used. Of the 86 DEB interventions, 37 were included for this study, 49 were excluded. In the study group, there was a significant difference in “re-intervention-free percentage at 12 months” before and after DEB: 19% vs. 69%. The hazard ratio for “DEBpresent” vs. “DEBabsent” was 0.23 (95% CI 0.14 to 0.36, p<0.001). Conclusions: This retrospective study suggests that DEBs significantly reduce re-intervention on recurrent in-stent AVF stenoses.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel drug-eluting balloons to recurrent in-stent stenoses in autogenous dialysis fistulas: A retrospective study ###Abstract: Purpose: To assess the effect of the Medtronic paclitaxel drug-eluting balloon (DEB) on re-intervention to in-stent stenoses in autogenous dialysis arteriovenous fistulas (AVFs). Background: AVF is the optimum haemodialysis access. The commonest problem is stenosis, preventing maturation, causing inadequate dialysis or precipitating occlusion. Conventional angioplasty has a high recurrence rate. Successful drug elution in the coronary circulation led us to use DEBs in recurrent AVF stenoses since 2010. Methods: This is a retrospective study, based on prospective audit data, using DEBs on recurrent in-stent stenotic lesions in the AVF circuit of our haemodialysis population. To analyse the effect of DEBs on re-intervention, we created two Kaplan–Meier curves. The first curve compares the last “disease-free-interval” pre-DEB intervention to the first “disease-free interval” post-DEB, giving us “re-intervention-free percentage at 12 months” pre- and post-DEB. The second curve takes into account the multiple pre- and post-DEB interventions to the index lesion, and uses a marginal proportional hazards model to estimate the hazard ratio for “DEBpresent vs. DEBabsent”. Results: From 1 September 2010 to 1 December 2013, we treated 625 AVF stenoses with endovascular techniques. In 86 of these stenoses, DEBs were used. Of the 86 DEB interventions, 37 were included for this study, 49 were excluded. In the study group, there was a significant difference in “re-intervention-free percentage at 12 months” before and after DEB: 19% vs. 69%. The hazard ratio for “DEBpresent” vs. “DEBabsent” was 0.23 (95% CI 0.14 to 0.36, p<0.001). Conclusions: This retrospective study suggests that DEBs significantly reduce re-intervention on recurrent in-stent AVF stenoses. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Paclitaxel drug-eluting balloons to recurrent in-stent stenoses in autogenous dialysis fistulas: A retrospective study ###Abstract: Purpose: To assess the effect of the Medtronic paclitaxel drug-eluting balloon (DEB) on re-intervention to in-stent stenoses in autogenous dialysis arteriovenous fistulas (AVFs). Background: AVF is the optimum haemodialysis access. The commonest problem is stenosis, preventing maturation, causing inadequate dialysis or precipitating occlusion. Conventional angioplasty has a high recurrence rate. Successful drug elution in the coronary circulation led us to use DEBs in recurrent AVF stenoses since 2010. Methods: This is a retrospective study, based on prospective audit data, using DEBs on recurrent in-stent stenotic lesions in the AVF circuit of our haemodialysis population. To analyse the effect of DEBs on re-intervention, we created two Kaplan–Meier curves. The first curve compares the last “disease-free-interval” pre-DEB intervention to the first “disease-free interval” post-DEB, giving us “re-intervention-free percentage at 12 months” pre- and post-DEB. The second curve takes into account the multiple pre- and post-DEB interventions to the index lesion, and uses a marginal proportional hazards model to estimate the hazard ratio for “DEBpresent vs. DEBabsent”. Results: From 1 September 2010 to 1 December 2013, we treated 625 AVF stenoses with endovascular techniques. In 86 of these stenoses, DEBs were used. Of the 86 DEB interventions, 37 were included for this study, 49 were excluded. In the study group, there was a significant difference in “re-intervention-free percentage at 12 months” before and after DEB: 19% vs. 69%. The hazard ratio for “DEBpresent” vs. “DEBabsent” was 0.23 (95% CI 0.14 to 0.36, p<0.001). Conclusions: This retrospective study suggests that DEBs significantly reduce re-intervention on recurrent in-stent AVF stenoses. [/INST] Include </s>
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Swinnen 2019
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Multicentre, randomised, blinded, control trial of drug-eluting balloon vs Sham in recurrent native dialysis fistula stenoses
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Background: Endovascular treatment of autogenous arteriovenous haemodialysis fistula stenosis has high reintervention rates. We investigate the effect of drug-eluting balloons in the treatment of recurrent haemodialysis fistula stenosis. Methods: This is a randomised, controlled, investigator-initiated and run, prospective, blinded, multicentre trial. Patients with recurrent autogenous arteriovenous haemodialysis fistula stenosis received standard endovascular treatment plus drug-eluting balloon or standard endovascular treatment plus uncoated balloon (Sham). Primary endpoint was late lumen loss in trial area on ultrasound at 6 weeks, 3, 6 and 12 months. Secondary endpoints were freedom from reintervention to the Index Trial Area and decline in fistula flow (Qa). Interim analysis was performed at 6 months (unblinded due to timeliness). Results: Patients with 132 recurrent stenoses (48% in bare Nitinol stents) were randomised with 70 receiving drug-eluting balloon and 62 Sham. At 6 months, decline in late lumen loss was 0.23 ± 0.03 mm/month for Sham and 0.045 ± 0.03 mm/month for drug-eluting balloon arm, a significant difference (0.18 mm, p = 0.0002). At 12 months, this difference persisted at 0.12 mm (p = 0.0003). At 6 months, significant difference in late lumen loss for instent restenoses (p = 0.0004) was observed, with non-significant difference for unstented restenoses (p = 0.065). Mean time for freedom from reintervention was 10.14 months for Sham versus 42.39 months for drug-eluting balloon (p = 0.001). The same was shown for instent (p = 0.014) and unstented (p = 0.029) restenoses. Qa decline rate at 6 months was 36.89 mL/min/month (Sham) and 0.41 mL/min (drug-eluting balloon). The difference was significant (36.48 mL/min; p = 0.02) and persisted to 12 months (p = 0.44). Conclusion: Paclitaxel drug-eluting balloon significantly delays restenosis after angioplasty for recurrent autogenous arteriovenous haemodialysis fistula stenosis, persisting to 12 months. Drug-eluting balloon significantly increases freedom from reintervention at 12 months with these effects true in stented and unstented fistulas.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Multicentre, randomised, blinded, control trial of drug-eluting balloon vs Sham in recurrent native dialysis fistula stenoses ###Abstract: Background: Endovascular treatment of autogenous arteriovenous haemodialysis fistula stenosis has high reintervention rates. We investigate the effect of drug-eluting balloons in the treatment of recurrent haemodialysis fistula stenosis. Methods: This is a randomised, controlled, investigator-initiated and run, prospective, blinded, multicentre trial. Patients with recurrent autogenous arteriovenous haemodialysis fistula stenosis received standard endovascular treatment plus drug-eluting balloon or standard endovascular treatment plus uncoated balloon (Sham). Primary endpoint was late lumen loss in trial area on ultrasound at 6 weeks, 3, 6 and 12 months. Secondary endpoints were freedom from reintervention to the Index Trial Area and decline in fistula flow (Qa). Interim analysis was performed at 6 months (unblinded due to timeliness). Results: Patients with 132 recurrent stenoses (48% in bare Nitinol stents) were randomised with 70 receiving drug-eluting balloon and 62 Sham. At 6 months, decline in late lumen loss was 0.23 ± 0.03 mm/month for Sham and 0.045 ± 0.03 mm/month for drug-eluting balloon arm, a significant difference (0.18 mm, p = 0.0002). At 12 months, this difference persisted at 0.12 mm (p = 0.0003). At 6 months, significant difference in late lumen loss for instent restenoses (p = 0.0004) was observed, with non-significant difference for unstented restenoses (p = 0.065). Mean time for freedom from reintervention was 10.14 months for Sham versus 42.39 months for drug-eluting balloon (p = 0.001). The same was shown for instent (p = 0.014) and unstented (p = 0.029) restenoses. Qa decline rate at 6 months was 36.89 mL/min/month (Sham) and 0.41 mL/min (drug-eluting balloon). The difference was significant (36.48 mL/min; p = 0.02) and persisted to 12 months (p = 0.44). Conclusion: Paclitaxel drug-eluting balloon significantly delays restenosis after angioplasty for recurrent autogenous arteriovenous haemodialysis fistula stenosis, persisting to 12 months. Drug-eluting balloon significantly increases freedom from reintervention at 12 months with these effects true in stented and unstented fistulas. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Multicentre, randomised, blinded, control trial of drug-eluting balloon vs Sham in recurrent native dialysis fistula stenoses ###Abstract: Background: Endovascular treatment of autogenous arteriovenous haemodialysis fistula stenosis has high reintervention rates. We investigate the effect of drug-eluting balloons in the treatment of recurrent haemodialysis fistula stenosis. Methods: This is a randomised, controlled, investigator-initiated and run, prospective, blinded, multicentre trial. Patients with recurrent autogenous arteriovenous haemodialysis fistula stenosis received standard endovascular treatment plus drug-eluting balloon or standard endovascular treatment plus uncoated balloon (Sham). Primary endpoint was late lumen loss in trial area on ultrasound at 6 weeks, 3, 6 and 12 months. Secondary endpoints were freedom from reintervention to the Index Trial Area and decline in fistula flow (Qa). Interim analysis was performed at 6 months (unblinded due to timeliness). Results: Patients with 132 recurrent stenoses (48% in bare Nitinol stents) were randomised with 70 receiving drug-eluting balloon and 62 Sham. At 6 months, decline in late lumen loss was 0.23 ± 0.03 mm/month for Sham and 0.045 ± 0.03 mm/month for drug-eluting balloon arm, a significant difference (0.18 mm, p = 0.0002). At 12 months, this difference persisted at 0.12 mm (p = 0.0003). At 6 months, significant difference in late lumen loss for instent restenoses (p = 0.0004) was observed, with non-significant difference for unstented restenoses (p = 0.065). Mean time for freedom from reintervention was 10.14 months for Sham versus 42.39 months for drug-eluting balloon (p = 0.001). The same was shown for instent (p = 0.014) and unstented (p = 0.029) restenoses. Qa decline rate at 6 months was 36.89 mL/min/month (Sham) and 0.41 mL/min (drug-eluting balloon). The difference was significant (36.48 mL/min; p = 0.02) and persisted to 12 months (p = 0.44). Conclusion: Paclitaxel drug-eluting balloon significantly delays restenosis after angioplasty for recurrent autogenous arteriovenous haemodialysis fistula stenosis, persisting to 12 months. Drug-eluting balloon significantly increases freedom from reintervention at 12 months with these effects true in stented and unstented fistulas. [/INST] Include </s>
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Tepe 2015
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Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease 12-month results from the IN.PACT SFA randomized Trial
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Background: Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease. Methods and Results: The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point was primary patency, defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94±4.89 and 8.81±5.12 cm (P=0.82) and 25.8% and 19.5% (P=0.22), respectively. DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA [P=0.10]). There were no device- or procedurerelated deaths and no major amputations. Conclusions: In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease 12-month results from the IN.PACT SFA randomized Trial ###Abstract: Background: Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease. Methods and Results: The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point was primary patency, defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94±4.89 and 8.81±5.12 cm (P=0.82) and 25.8% and 19.5% (P=0.22), respectively. DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA [P=0.10]). There were no device- or procedurerelated deaths and no major amputations. Conclusions: In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease 12-month results from the IN.PACT SFA randomized Trial ###Abstract: Background: Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease. Methods and Results: The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point was primary patency, defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94±4.89 and 8.81±5.12 cm (P=0.82) and 25.8% and 19.5% (P=0.22), respectively. DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA [P=0.10]). There were no device- or procedurerelated deaths and no major amputations. Conclusions: In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and [/INST] Include </s>
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Tepe 2019
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Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study
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Objectives: This study evaluated the 12-month safety and effectiveness of a paclitaxel drug-coated balloon for treatment of intermittent claudication or rest pain in subjects with femoropopliteal chronic total occlusions (CTO). Background: CTOs are difficult to treat, and the optimal intervention remains to be determined. Methods: The IN.PACT Global Study is an international single-arm study that enrolled 1,535 patients with symptomatic femoropopliteal artery disease. The study contains prospectively defined cohorts with prospectively planned imaging analyses, including a CTO (≥5 cm) cohort in which subjects underwent duplex ultrasonography analyzed by an independent core laboratory. The primary safety endpoint was a composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and target vessel revascularization through 12 months. An independent Clinical Events Committee adjudicated all adverse events. The primary effectiveness endpoint was primary patency at 12 months, defined as freedom from clinically driven target lesion revascularization and freedom from restenosis. Results: The CTO imaging cohort had 126 subjects with 127 lesions (mean lesion length 22.83 ± 9.76 cm). Primary patency by Kaplan-Meier estimate was 85.3% through 12 months. Provisional stenting was performed in 46.8% of lesions. The primary safety composite endpoint was achieved by 88.7% of subjects. There were no device- or procedure-related deaths through 30 days or major target limb amputations through 12 months. Conclusions: The paclitaxel drug-coated balloon was safe and highly effective at 12 months after treatment of subjects with CTO ≥5 cm in the femoropopliteal arteries. (IN.PACT Global Clinical Study; NCT01609296)
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study ###Abstract: Objectives: This study evaluated the 12-month safety and effectiveness of a paclitaxel drug-coated balloon for treatment of intermittent claudication or rest pain in subjects with femoropopliteal chronic total occlusions (CTO). Background: CTOs are difficult to treat, and the optimal intervention remains to be determined. Methods: The IN.PACT Global Study is an international single-arm study that enrolled 1,535 patients with symptomatic femoropopliteal artery disease. The study contains prospectively defined cohorts with prospectively planned imaging analyses, including a CTO (≥5 cm) cohort in which subjects underwent duplex ultrasonography analyzed by an independent core laboratory. The primary safety endpoint was a composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and target vessel revascularization through 12 months. An independent Clinical Events Committee adjudicated all adverse events. The primary effectiveness endpoint was primary patency at 12 months, defined as freedom from clinically driven target lesion revascularization and freedom from restenosis. Results: The CTO imaging cohort had 126 subjects with 127 lesions (mean lesion length 22.83 ± 9.76 cm). Primary patency by Kaplan-Meier estimate was 85.3% through 12 months. Provisional stenting was performed in 46.8% of lesions. The primary safety composite endpoint was achieved by 88.7% of subjects. There were no device- or procedure-related deaths through 30 days or major target limb amputations through 12 months. Conclusions: The paclitaxel drug-coated balloon was safe and highly effective at 12 months after treatment of subjects with CTO ≥5 cm in the femoropopliteal arteries. (IN.PACT Global Clinical Study; NCT01609296) [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study ###Abstract: Objectives: This study evaluated the 12-month safety and effectiveness of a paclitaxel drug-coated balloon for treatment of intermittent claudication or rest pain in subjects with femoropopliteal chronic total occlusions (CTO). Background: CTOs are difficult to treat, and the optimal intervention remains to be determined. Methods: The IN.PACT Global Study is an international single-arm study that enrolled 1,535 patients with symptomatic femoropopliteal artery disease. The study contains prospectively defined cohorts with prospectively planned imaging analyses, including a CTO (≥5 cm) cohort in which subjects underwent duplex ultrasonography analyzed by an independent core laboratory. The primary safety endpoint was a composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and target vessel revascularization through 12 months. An independent Clinical Events Committee adjudicated all adverse events. The primary effectiveness endpoint was primary patency at 12 months, defined as freedom from clinically driven target lesion revascularization and freedom from restenosis. Results: The CTO imaging cohort had 126 subjects with 127 lesions (mean lesion length 22.83 ± 9.76 cm). Primary patency by Kaplan-Meier estimate was 85.3% through 12 months. Provisional stenting was performed in 46.8% of lesions. The primary safety composite endpoint was achieved by 88.7% of subjects. There were no device- or procedure-related deaths through 30 days or major target limb amputations through 12 months. Conclusions: The paclitaxel drug-coated balloon was safe and highly effective at 12 months after treatment of subjects with CTO ≥5 cm in the femoropopliteal arteries. (IN.PACT Global Clinical Study; NCT01609296) [/INST] Include </s>
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Torsello 2020
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Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort
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Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.
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Include
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DI1 - On Label
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort ###Abstract: Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort ###Abstract: Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure. [/INST] Include </s>
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Tsuchiya 2019
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Healing of femoral artery dissection after drug-coated balloon angioplasty: A case report with intravascular ultrasonography and angioscopy images
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Early 80s male with intermitted claudication underwent endovascular therapy for atherosclerotic stenosis at left external iliac artery and middle of superficial femoral artery. Patient also had chronic atrial fibrillation, diabetes mellitus, and hypertension. After stent deployment for external iliac artery lesion, a short superficial femoral artery lesion was performed with angioplasty using drug-coated balloon. The drug-coated balloon angioplasty resulted in 50% residual stenosis with linear dissection; however, provisional stenting was not performed as decent ante-grade blood flow allowed 10 extra minutes. Medication involved ongoing use of aspirin 100 mg and rivaroxaban 15 mg. Angiography post 3 months from index procedure showed external iliac artery and superficial femoral artery patency and healing of intimal dissection at superficial femoral artery lesion was estimated by intravascular ultrasonography. In angioscopy findings, red thrombus was seen in dissection cavity.
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Include
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DI3 - Case Report
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Healing of femoral artery dissection after drug-coated balloon angioplasty: A case report with intravascular ultrasonography and angioscopy images ###Abstract: Early 80s male with intermitted claudication underwent endovascular therapy for atherosclerotic stenosis at left external iliac artery and middle of superficial femoral artery. Patient also had chronic atrial fibrillation, diabetes mellitus, and hypertension. After stent deployment for external iliac artery lesion, a short superficial femoral artery lesion was performed with angioplasty using drug-coated balloon. The drug-coated balloon angioplasty resulted in 50% residual stenosis with linear dissection; however, provisional stenting was not performed as decent ante-grade blood flow allowed 10 extra minutes. Medication involved ongoing use of aspirin 100 mg and rivaroxaban 15 mg. Angiography post 3 months from index procedure showed external iliac artery and superficial femoral artery patency and healing of intimal dissection at superficial femoral artery lesion was estimated by intravascular ultrasonography. In angioscopy findings, red thrombus was seen in dissection cavity. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Healing of femoral artery dissection after drug-coated balloon angioplasty: A case report with intravascular ultrasonography and angioscopy images ###Abstract: Early 80s male with intermitted claudication underwent endovascular therapy for atherosclerotic stenosis at left external iliac artery and middle of superficial femoral artery. Patient also had chronic atrial fibrillation, diabetes mellitus, and hypertension. After stent deployment for external iliac artery lesion, a short superficial femoral artery lesion was performed with angioplasty using drug-coated balloon. The drug-coated balloon angioplasty resulted in 50% residual stenosis with linear dissection; however, provisional stenting was not performed as decent ante-grade blood flow allowed 10 extra minutes. Medication involved ongoing use of aspirin 100 mg and rivaroxaban 15 mg. Angiography post 3 months from index procedure showed external iliac artery and superficial femoral artery patency and healing of intimal dissection at superficial femoral artery lesion was estimated by intravascular ultrasonography. In angioscopy findings, red thrombus was seen in dissection cavity. [/INST] Include </s>
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Werner 2016b
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Evaluation of the biodegradable Igaki-Tamai scaffold after drug-eluting balloon treatment of de novo superficial femoral artery lesions: The GAIA-DEB study
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Purpose: To evaluate the safety and efficacy of the Igaki-Tamai biodegradable scaffold after drug-eluting balloon (DEB) angioplasty in patients with occlusive superficial femoral artery (SFA) disease. Methods: A prospective, single-center, nonrandomized study enrolled 20 patients (mean age 66.7±11.6 years; 14 men) with symptomatic de novo SFA lesions undergoing angioplasty with the In.Pact Admiral paclitaxel-coated balloon and subsequent implantation of the Igaki-Tamai bioresorbable scaffold. All patients were claudicants. The average diameter stenosis was 89.7%, and the mean length was 43.6 mm. Clinical examinations with duplex sonography were performed after 1, 6, 9, and 12 months. The main study outcomes were technical success, restenosis, target lesion revascularization (TLR), ankle-brachial index (ABI) improvement, and changes in quality of life evaluated with the walking impairment questionnaire. Safety was assessed by monitoring the occurrence of adverse events. Results: Angioplasty with a paclitaxel-coated balloon was performed in all patients, resulting in an average diameter stenosis of 24%. Subsequent implantation of the Igaki-Tamai scaffold reduced the average diameter stenosis to 3.5%. In the first 6 months, 2 cases of restenosis were reported, with no TLRs within that period. However, by the 12-month follow-up in 19 patients, 11 patients had lost in-stent patency. Among these patients, 8 had TLRs, which were the only adverse events recorded that were referable to the procedure. Quality-of-life assessments showed improvement in the majority of patients. Conclusion: The GAIA-DEB study shows that DEB treatment of the femoral artery prior to the implantation of the biodegradable Igaki-Tamai scaffold is safe. However, the antiproliferative actions of paclitaxel in the vessel wall were not effective in preventing restenosis. In-stent restenosis occurred predominantly after 6 months.
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Include
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DI4 - Unsegreagated
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Evaluation of the biodegradable Igaki-Tamai scaffold after drug-eluting balloon treatment of de novo superficial femoral artery lesions: The GAIA-DEB study ###Abstract: Purpose: To evaluate the safety and efficacy of the Igaki-Tamai biodegradable scaffold after drug-eluting balloon (DEB) angioplasty in patients with occlusive superficial femoral artery (SFA) disease. Methods: A prospective, single-center, nonrandomized study enrolled 20 patients (mean age 66.7±11.6 years; 14 men) with symptomatic de novo SFA lesions undergoing angioplasty with the In.Pact Admiral paclitaxel-coated balloon and subsequent implantation of the Igaki-Tamai bioresorbable scaffold. All patients were claudicants. The average diameter stenosis was 89.7%, and the mean length was 43.6 mm. Clinical examinations with duplex sonography were performed after 1, 6, 9, and 12 months. The main study outcomes were technical success, restenosis, target lesion revascularization (TLR), ankle-brachial index (ABI) improvement, and changes in quality of life evaluated with the walking impairment questionnaire. Safety was assessed by monitoring the occurrence of adverse events. Results: Angioplasty with a paclitaxel-coated balloon was performed in all patients, resulting in an average diameter stenosis of 24%. Subsequent implantation of the Igaki-Tamai scaffold reduced the average diameter stenosis to 3.5%. In the first 6 months, 2 cases of restenosis were reported, with no TLRs within that period. However, by the 12-month follow-up in 19 patients, 11 patients had lost in-stent patency. Among these patients, 8 had TLRs, which were the only adverse events recorded that were referable to the procedure. Quality-of-life assessments showed improvement in the majority of patients. Conclusion: The GAIA-DEB study shows that DEB treatment of the femoral artery prior to the implantation of the biodegradable Igaki-Tamai scaffold is safe. However, the antiproliferative actions of paclitaxel in the vessel wall were not effective in preventing restenosis. In-stent restenosis occurred predominantly after 6 months. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Evaluation of the biodegradable Igaki-Tamai scaffold after drug-eluting balloon treatment of de novo superficial femoral artery lesions: The GAIA-DEB study ###Abstract: Purpose: To evaluate the safety and efficacy of the Igaki-Tamai biodegradable scaffold after drug-eluting balloon (DEB) angioplasty in patients with occlusive superficial femoral artery (SFA) disease. Methods: A prospective, single-center, nonrandomized study enrolled 20 patients (mean age 66.7±11.6 years; 14 men) with symptomatic de novo SFA lesions undergoing angioplasty with the In.Pact Admiral paclitaxel-coated balloon and subsequent implantation of the Igaki-Tamai bioresorbable scaffold. All patients were claudicants. The average diameter stenosis was 89.7%, and the mean length was 43.6 mm. Clinical examinations with duplex sonography were performed after 1, 6, 9, and 12 months. The main study outcomes were technical success, restenosis, target lesion revascularization (TLR), ankle-brachial index (ABI) improvement, and changes in quality of life evaluated with the walking impairment questionnaire. Safety was assessed by monitoring the occurrence of adverse events. Results: Angioplasty with a paclitaxel-coated balloon was performed in all patients, resulting in an average diameter stenosis of 24%. Subsequent implantation of the Igaki-Tamai scaffold reduced the average diameter stenosis to 3.5%. In the first 6 months, 2 cases of restenosis were reported, with no TLRs within that period. However, by the 12-month follow-up in 19 patients, 11 patients had lost in-stent patency. Among these patients, 8 had TLRs, which were the only adverse events recorded that were referable to the procedure. Quality-of-life assessments showed improvement in the majority of patients. Conclusion: The GAIA-DEB study shows that DEB treatment of the femoral artery prior to the implantation of the biodegradable Igaki-Tamai scaffold is safe. However, the antiproliferative actions of paclitaxel in the vessel wall were not effective in preventing restenosis. In-stent restenosis occurred predominantly after 6 months. [/INST] Include </s>
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Xue 2018
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Successful management of recurrent iliofemoral venous in-stent stenosis (ISR) with a drug coated balloon (DCB)
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Include
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DI3 - Case Report
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Successful management of recurrent iliofemoral venous in-stent stenosis (ISR) with a drug coated balloon (DCB) ###Abstract: None [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Successful management of recurrent iliofemoral venous in-stent stenosis (ISR) with a drug coated balloon (DCB) ###Abstract: None [/INST] Include </s>
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Albrecht 2019a
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Two-Year Mortality After Angioplasty of the Femoro-Popliteal Artery with Uncoated Balloons and Paclitaxel-Coated Balloons—A Pooled Analysis of Four Randomized Controlled Multicenter Trials
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Purpose: In view of a recent meta-analysis reporting increased mortality following angioplasty with paclitaxel-coated devices in peripheral arteries, we performed a patient-level 2-year mortality analysis based on pooled original data of four randomized controlled trials (THUNDER, FEMPAC, PACIFIER and CONSEQUENT). Methods and Results: Clinical data of four randomized controlled trial were pooled to assess 2-year mortality following paclitaxel-coated balloon (PCB) angioplasty compared to angioplasty without paclitaxel (control group). A logistic regression model was applied to identify potential predictors of mortality. At two years, 13 of 185 (7.0%) patients had died in the control group and 16/184 (8.7%) in the PBC group, p = 0.55. Kaplan–Meier analysis revealed no significant difference from all-cause death at 2 years (log rank p = 0.54). Causes of death were well balanced between the groups with no pattern or trend in favour of any specific causes in the PBC group. Logistic regression revealed that treatment groups (controls or PBC) were not a predictor of 2-year mortality. The only predictor for mortality was patient age ≥ 75 years. The delivered paclitaxel doses per patient were not significantly different in patients that died and those who did not die during the 24-month follow-up (5.300 ± 4.224 μg vs. 6.248 ± 4.629 μg, p = 0.433). Conclusions: Based on original patient-level data of four pooled randomized controlled trials, we found no increase in 2-year mortality in patients treated with PCB compared to control patients treated with uncoated balloons. Causes of death were well balanced between PCB and control patients.
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DE1 - Incorrect Device
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Two-Year Mortality After Angioplasty of the Femoro-Popliteal Artery with Uncoated Balloons and Paclitaxel-Coated Balloons—A Pooled Analysis of Four Randomized Controlled Multicenter Trials ###Abstract: Purpose: In view of a recent meta-analysis reporting increased mortality following angioplasty with paclitaxel-coated devices in peripheral arteries, we performed a patient-level 2-year mortality analysis based on pooled original data of four randomized controlled trials (THUNDER, FEMPAC, PACIFIER and CONSEQUENT). Methods and Results: Clinical data of four randomized controlled trial were pooled to assess 2-year mortality following paclitaxel-coated balloon (PCB) angioplasty compared to angioplasty without paclitaxel (control group). A logistic regression model was applied to identify potential predictors of mortality. At two years, 13 of 185 (7.0%) patients had died in the control group and 16/184 (8.7%) in the PBC group, p = 0.55. Kaplan–Meier analysis revealed no significant difference from all-cause death at 2 years (log rank p = 0.54). Causes of death were well balanced between the groups with no pattern or trend in favour of any specific causes in the PBC group. Logistic regression revealed that treatment groups (controls or PBC) were not a predictor of 2-year mortality. The only predictor for mortality was patient age ≥ 75 years. The delivered paclitaxel doses per patient were not significantly different in patients that died and those who did not die during the 24-month follow-up (5.300 ± 4.224 μg vs. 6.248 ± 4.629 μg, p = 0.433). Conclusions: Based on original patient-level data of four pooled randomized controlled trials, we found no increase in 2-year mortality in patients treated with PCB compared to control patients treated with uncoated balloons. Causes of death were well balanced between PCB and control patients. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Two-Year Mortality After Angioplasty of the Femoro-Popliteal Artery with Uncoated Balloons and Paclitaxel-Coated Balloons—A Pooled Analysis of Four Randomized Controlled Multicenter Trials ###Abstract: Purpose: In view of a recent meta-analysis reporting increased mortality following angioplasty with paclitaxel-coated devices in peripheral arteries, we performed a patient-level 2-year mortality analysis based on pooled original data of four randomized controlled trials (THUNDER, FEMPAC, PACIFIER and CONSEQUENT). Methods and Results: Clinical data of four randomized controlled trial were pooled to assess 2-year mortality following paclitaxel-coated balloon (PCB) angioplasty compared to angioplasty without paclitaxel (control group). A logistic regression model was applied to identify potential predictors of mortality. At two years, 13 of 185 (7.0%) patients had died in the control group and 16/184 (8.7%) in the PBC group, p = 0.55. Kaplan–Meier analysis revealed no significant difference from all-cause death at 2 years (log rank p = 0.54). Causes of death were well balanced between the groups with no pattern or trend in favour of any specific causes in the PBC group. Logistic regression revealed that treatment groups (controls or PBC) were not a predictor of 2-year mortality. The only predictor for mortality was patient age ≥ 75 years. The delivered paclitaxel doses per patient were not significantly different in patients that died and those who did not die during the 24-month follow-up (5.300 ± 4.224 μg vs. 6.248 ± 4.629 μg, p = 0.433). Conclusions: Based on original patient-level data of four pooled randomized controlled trials, we found no increase in 2-year mortality in patients treated with PCB compared to control patients treated with uncoated balloons. Causes of death were well balanced between PCB and control patients. [/INST] Exclude </s>
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Albrecht 2019b
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Impact of Patient and Lesion Characteristics on Drug-Coated Balloon Angioplasty in the Femoropopliteal Artery: A Pooled Analysis of Four Randomized Controlled Multicenter Trials
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Objectives: The principal objective of this pooled analysis was to investigate various patient and lesion characteristics on late lumen loss (LLL) after drug-coated balloon (DCB) angioplasty. Background: Four randomized controlled trials (THUNDER, FEMPAC, PACIFIER, CONSEQUENT) were pooled to investigate the influence of various patient and lesion characteristics on DCB angioplasty and on plain old balloon angioplasty (POBA) in patients with femoropopliteal artery disease. Methods: Angiographic data from 355 patients were pooled to assess the impact of patient (demographics, cardiovascular risk factors, cardiovascular co-morbidities, Rutherford stages) and lesion-/procedure-related (location, occlusion, length, restenosis, calcification, subintimal crossing, post-dilatation, dissection, stenting) characteristics on LLL. Linear regression models were utilized with LLL as the dependent variable to determine the predictive value of cardiovascular and lesion-/procedure-related factors. Results: Observational statistics revealed that LLL was lower in the DCB group as compared to POBA independent of all tested patient variables. LLL after DCB was also independent of most lesion and procedural characteristics except for lesion length and bailout stenting. LLL increased with lesion length in both treatment groups. Bailout stenting did not improve LLL in the DCB group but did so in the POBA group (0.74 ± 1.07 mm vs. 1.22 ± 1.36 mm, p = 0.043). Conclusions: DCB was superior to POBA for all tested patient subgroups and lesion subgroups. Our results suggest that all patients and lesions benefit to a similar degree from the use of DCB. DCB-PTA should therefore be preferred to POBA in all patients with steno-occlusive femoropopliteal lesions.
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Exclude
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DE1 - Incorrect Device
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Impact of Patient and Lesion Characteristics on Drug-Coated Balloon Angioplasty in the Femoropopliteal Artery: A Pooled Analysis of Four Randomized Controlled Multicenter Trials ###Abstract: Objectives: The principal objective of this pooled analysis was to investigate various patient and lesion characteristics on late lumen loss (LLL) after drug-coated balloon (DCB) angioplasty. Background: Four randomized controlled trials (THUNDER, FEMPAC, PACIFIER, CONSEQUENT) were pooled to investigate the influence of various patient and lesion characteristics on DCB angioplasty and on plain old balloon angioplasty (POBA) in patients with femoropopliteal artery disease. Methods: Angiographic data from 355 patients were pooled to assess the impact of patient (demographics, cardiovascular risk factors, cardiovascular co-morbidities, Rutherford stages) and lesion-/procedure-related (location, occlusion, length, restenosis, calcification, subintimal crossing, post-dilatation, dissection, stenting) characteristics on LLL. Linear regression models were utilized with LLL as the dependent variable to determine the predictive value of cardiovascular and lesion-/procedure-related factors. Results: Observational statistics revealed that LLL was lower in the DCB group as compared to POBA independent of all tested patient variables. LLL after DCB was also independent of most lesion and procedural characteristics except for lesion length and bailout stenting. LLL increased with lesion length in both treatment groups. Bailout stenting did not improve LLL in the DCB group but did so in the POBA group (0.74 ± 1.07 mm vs. 1.22 ± 1.36 mm, p = 0.043). Conclusions: DCB was superior to POBA for all tested patient subgroups and lesion subgroups. Our results suggest that all patients and lesions benefit to a similar degree from the use of DCB. DCB-PTA should therefore be preferred to POBA in all patients with steno-occlusive femoropopliteal lesions. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Impact of Patient and Lesion Characteristics on Drug-Coated Balloon Angioplasty in the Femoropopliteal Artery: A Pooled Analysis of Four Randomized Controlled Multicenter Trials ###Abstract: Objectives: The principal objective of this pooled analysis was to investigate various patient and lesion characteristics on late lumen loss (LLL) after drug-coated balloon (DCB) angioplasty. Background: Four randomized controlled trials (THUNDER, FEMPAC, PACIFIER, CONSEQUENT) were pooled to investigate the influence of various patient and lesion characteristics on DCB angioplasty and on plain old balloon angioplasty (POBA) in patients with femoropopliteal artery disease. Methods: Angiographic data from 355 patients were pooled to assess the impact of patient (demographics, cardiovascular risk factors, cardiovascular co-morbidities, Rutherford stages) and lesion-/procedure-related (location, occlusion, length, restenosis, calcification, subintimal crossing, post-dilatation, dissection, stenting) characteristics on LLL. Linear regression models were utilized with LLL as the dependent variable to determine the predictive value of cardiovascular and lesion-/procedure-related factors. Results: Observational statistics revealed that LLL was lower in the DCB group as compared to POBA independent of all tested patient variables. LLL after DCB was also independent of most lesion and procedural characteristics except for lesion length and bailout stenting. LLL increased with lesion length in both treatment groups. Bailout stenting did not improve LLL in the DCB group but did so in the POBA group (0.74 ± 1.07 mm vs. 1.22 ± 1.36 mm, p = 0.043). Conclusions: DCB was superior to POBA for all tested patient subgroups and lesion subgroups. Our results suggest that all patients and lesions benefit to a similar degree from the use of DCB. DCB-PTA should therefore be preferred to POBA in all patients with steno-occlusive femoropopliteal lesions. [/INST] Exclude </s>
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Alfonso 2017
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State of the art: Balloon catheter technologies - Drug-coated balloon
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Four decades after its introduction into clinical practice, coronary balloon angioplasty is still used during most coronary interventions. Conventional balloon angioplasty is frequently used to predilate complex or severe lesions and remains of major value to optimise the results of stent implantation. Plain balloon angioplasty is still used alone in some anatomic scenarios where stent implantation is not desirable (very small vessels or diffuse lesions, large resistant thrombus burden, side branches of bifurcations). However, this technique is hampered by a relatively high restenosis risk. Recently, drug-coated balloons (DCB) have been shown to provide an attractive new tool for the "leave nothing behind" strategy. Many studies have demonstrated that DCB are indeed safe and effective. Evidence of the value of DCB in patients with ISR is overwhelming. DCB are attractive for selected de novo coronary lesions (small vessels, diffuse disease, side branches). DCB have also gained major evidence supporting their clinical efficacy in the peripheral arterial territory. Further studies are required to elucidate the relative value of DCB compared with alternative strategies (namely new-generation drug-eluting stents) in different clinical and anatomic scenarios.
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Exclude
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DE10 - Wrong Article Type
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: State of the art: Balloon catheter technologies - Drug-coated balloon ###Abstract: Four decades after its introduction into clinical practice, coronary balloon angioplasty is still used during most coronary interventions. Conventional balloon angioplasty is frequently used to predilate complex or severe lesions and remains of major value to optimise the results of stent implantation. Plain balloon angioplasty is still used alone in some anatomic scenarios where stent implantation is not desirable (very small vessels or diffuse lesions, large resistant thrombus burden, side branches of bifurcations). However, this technique is hampered by a relatively high restenosis risk. Recently, drug-coated balloons (DCB) have been shown to provide an attractive new tool for the "leave nothing behind" strategy. Many studies have demonstrated that DCB are indeed safe and effective. Evidence of the value of DCB in patients with ISR is overwhelming. DCB are attractive for selected de novo coronary lesions (small vessels, diffuse disease, side branches). DCB have also gained major evidence supporting their clinical efficacy in the peripheral arterial territory. Further studies are required to elucidate the relative value of DCB compared with alternative strategies (namely new-generation drug-eluting stents) in different clinical and anatomic scenarios. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: State of the art: Balloon catheter technologies - Drug-coated balloon ###Abstract: Four decades after its introduction into clinical practice, coronary balloon angioplasty is still used during most coronary interventions. Conventional balloon angioplasty is frequently used to predilate complex or severe lesions and remains of major value to optimise the results of stent implantation. Plain balloon angioplasty is still used alone in some anatomic scenarios where stent implantation is not desirable (very small vessels or diffuse lesions, large resistant thrombus burden, side branches of bifurcations). However, this technique is hampered by a relatively high restenosis risk. Recently, drug-coated balloons (DCB) have been shown to provide an attractive new tool for the "leave nothing behind" strategy. Many studies have demonstrated that DCB are indeed safe and effective. Evidence of the value of DCB in patients with ISR is overwhelming. DCB are attractive for selected de novo coronary lesions (small vessels, diffuse disease, side branches). DCB have also gained major evidence supporting their clinical efficacy in the peripheral arterial territory. Further studies are required to elucidate the relative value of DCB compared with alternative strategies (namely new-generation drug-eluting stents) in different clinical and anatomic scenarios. [/INST] Exclude </s>
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Alkhouli 2016
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Coronary artery fenestration prior to stenting in spontaneous coronary artery dissection
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Percutaneous coronary intervention (PCI) in patients with spontaneous coronary artery dissection is associated with high rates of complications and suboptimal long-term outcomes. Coronary artery fenestration with cutting balloon angioplasty prior to stenting can prevent the expansion of intramural hematoma and optimize PCI outcomes in this patient population. © 2015 Wiley Periodicals, Inc.
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Exclude
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DE2 - Wrong Topic
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Coronary artery fenestration prior to stenting in spontaneous coronary artery dissection ###Abstract: Percutaneous coronary intervention (PCI) in patients with spontaneous coronary artery dissection is associated with high rates of complications and suboptimal long-term outcomes. Coronary artery fenestration with cutting balloon angioplasty prior to stenting can prevent the expansion of intramural hematoma and optimize PCI outcomes in this patient population. © 2015 Wiley Periodicals, Inc. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Coronary artery fenestration prior to stenting in spontaneous coronary artery dissection ###Abstract: Percutaneous coronary intervention (PCI) in patients with spontaneous coronary artery dissection is associated with high rates of complications and suboptimal long-term outcomes. Coronary artery fenestration with cutting balloon angioplasty prior to stenting can prevent the expansion of intramural hematoma and optimize PCI outcomes in this patient population. © 2015 Wiley Periodicals, Inc. [/INST] Exclude </s>
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Ambrosini 2017
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The combined use of Drug-eluting balloon and Excimer laser for coronary artery Restenosis In-Stent Treatment: The DERIST study
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Aim Stents reduce angiographic restenosis in comparison with balloon angioplasty. The rate of in-stent restenosis (ISR), although less frequent than post-angioplasty restenosis, is becoming increasingly prevalent due to the recent exponential increase in the use of intracoronary stents. The aim of this study is to evaluate angiographic and clinical outcomes of PTCA in combination with the use of excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) in treatment of in-stent restenosis (ISR). Methods and results This multi-centric case-control study evaluated angiographic and clinical outcomes of PTCA with excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) in 80 patients with in-stent restenosis (ISR). All patients underwent nine months of clinical and a coronary angiography follow-up. This study showed clinical and angiographic long-term success in the 91% of the patients. The incidence of myocardial infarctions and deaths was lower than the rate after plain balloon angioplasty within the stent. Conclusions This study showed that excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) may be an alternative treatment for in-stent restenosis (ISR).
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Exclude
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DE1 - Incorrect Device
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: The combined use of Drug-eluting balloon and Excimer laser for coronary artery Restenosis In-Stent Treatment: The DERIST study ###Abstract: Aim Stents reduce angiographic restenosis in comparison with balloon angioplasty. The rate of in-stent restenosis (ISR), although less frequent than post-angioplasty restenosis, is becoming increasingly prevalent due to the recent exponential increase in the use of intracoronary stents. The aim of this study is to evaluate angiographic and clinical outcomes of PTCA in combination with the use of excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) in treatment of in-stent restenosis (ISR). Methods and results This multi-centric case-control study evaluated angiographic and clinical outcomes of PTCA with excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) in 80 patients with in-stent restenosis (ISR). All patients underwent nine months of clinical and a coronary angiography follow-up. This study showed clinical and angiographic long-term success in the 91% of the patients. The incidence of myocardial infarctions and deaths was lower than the rate after plain balloon angioplasty within the stent. Conclusions This study showed that excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) may be an alternative treatment for in-stent restenosis (ISR). [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: The combined use of Drug-eluting balloon and Excimer laser for coronary artery Restenosis In-Stent Treatment: The DERIST study ###Abstract: Aim Stents reduce angiographic restenosis in comparison with balloon angioplasty. The rate of in-stent restenosis (ISR), although less frequent than post-angioplasty restenosis, is becoming increasingly prevalent due to the recent exponential increase in the use of intracoronary stents. The aim of this study is to evaluate angiographic and clinical outcomes of PTCA in combination with the use of excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) in treatment of in-stent restenosis (ISR). Methods and results This multi-centric case-control study evaluated angiographic and clinical outcomes of PTCA with excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) in 80 patients with in-stent restenosis (ISR). All patients underwent nine months of clinical and a coronary angiography follow-up. This study showed clinical and angiographic long-term success in the 91% of the patients. The incidence of myocardial infarctions and deaths was lower than the rate after plain balloon angioplasty within the stent. Conclusions This study showed that excimer laser coronary angioplasty (ELCA) and drug-eluting balloon (DEB) may be an alternative treatment for in-stent restenosis (ISR). [/INST] Exclude </s>
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Anantha 2020
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Safety and efficacy of paclitaxel drug-coated balloon in femoropopliteal in-stent restenosis
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Introduction: The femoropopliteal (FP) segment is a common site of involvement in peripheral arterial disease (PAD) and endovascular therapy has been shown to be safe and effective in the treatment of FP disease. Self-expanding nitinol stents are now frequently used for the treatment of FP disease but in-stent restenosis (ISR) remains a major issue that can lead to recurrence of symptoms requiring repeated revascularizations. Compared to plain old balloon angioplasty (POBA), drug-coated balloons (DCBs) have shown promising results with reduction of ISR rates and target lesion revascularization (TLR). Areas covered: The aim of this review is to describe the mechanisms and classification of ISR and to summarize the available data on outcomes of all DCBs, especially in the treatment of FP ISR. Expert opinion: Currently available data supports the use of DCBs as a first-line therapy in patients with FP ISR, with lower rates of TLR and higher patency rates at 1-year follow-up, when compared to POBA. Further randomized studies are essential to evaluate longer term safety and efficacy of DCBs.
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Exclude
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DE10 - Wrong Article Type
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Safety and efficacy of paclitaxel drug-coated balloon in femoropopliteal in-stent restenosis ###Abstract: Introduction: The femoropopliteal (FP) segment is a common site of involvement in peripheral arterial disease (PAD) and endovascular therapy has been shown to be safe and effective in the treatment of FP disease. Self-expanding nitinol stents are now frequently used for the treatment of FP disease but in-stent restenosis (ISR) remains a major issue that can lead to recurrence of symptoms requiring repeated revascularizations. Compared to plain old balloon angioplasty (POBA), drug-coated balloons (DCBs) have shown promising results with reduction of ISR rates and target lesion revascularization (TLR). Areas covered: The aim of this review is to describe the mechanisms and classification of ISR and to summarize the available data on outcomes of all DCBs, especially in the treatment of FP ISR. Expert opinion: Currently available data supports the use of DCBs as a first-line therapy in patients with FP ISR, with lower rates of TLR and higher patency rates at 1-year follow-up, when compared to POBA. Further randomized studies are essential to evaluate longer term safety and efficacy of DCBs. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Safety and efficacy of paclitaxel drug-coated balloon in femoropopliteal in-stent restenosis ###Abstract: Introduction: The femoropopliteal (FP) segment is a common site of involvement in peripheral arterial disease (PAD) and endovascular therapy has been shown to be safe and effective in the treatment of FP disease. Self-expanding nitinol stents are now frequently used for the treatment of FP disease but in-stent restenosis (ISR) remains a major issue that can lead to recurrence of symptoms requiring repeated revascularizations. Compared to plain old balloon angioplasty (POBA), drug-coated balloons (DCBs) have shown promising results with reduction of ISR rates and target lesion revascularization (TLR). Areas covered: The aim of this review is to describe the mechanisms and classification of ISR and to summarize the available data on outcomes of all DCBs, especially in the treatment of FP ISR. Expert opinion: Currently available data supports the use of DCBs as a first-line therapy in patients with FP ISR, with lower rates of TLR and higher patency rates at 1-year follow-up, when compared to POBA. Further randomized studies are essential to evaluate longer term safety and efficacy of DCBs. [/INST] Exclude </s>
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Ang 2018
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Drug-coated balloons: Technologies and clinical applications
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The progress and development of drug-coated balloons (DCBs) represents an emerging alternative treatment in peripheral and coronary artery diseases, particularly when a non-stent approach is necessary. Several studies and meta-analyses have evaluated the clinical outcomes of DCBs in different lesions and this review aims to compile the progress and updated clinical data of DCB strategy in both peripheral artery diseases (PAD) and coronary artery diseases (CAD). The review highlights that clinical data has encouraged the use of DCB for applications in PAD and in the treatment of coronary in-stent restenosis (ISR). The employment of DCB in side branch treatment of bifurcation lesions has been reported to be feasible and safe, with good angiographic and clinical outcome. The use of DCB for arteriovenous fistula and grafts stenoses is a promising strategy, but more clinical data is required to draw reliable conclusions. The limitations and impact of the current generation of DCBs will be discussed and the clinical development of newer generation of the device is also covered in this review.
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Exclude
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DE12 - Wrong Article Type
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloons: Technologies and clinical applications ###Abstract: The progress and development of drug-coated balloons (DCBs) represents an emerging alternative treatment in peripheral and coronary artery diseases, particularly when a non-stent approach is necessary. Several studies and meta-analyses have evaluated the clinical outcomes of DCBs in different lesions and this review aims to compile the progress and updated clinical data of DCB strategy in both peripheral artery diseases (PAD) and coronary artery diseases (CAD). The review highlights that clinical data has encouraged the use of DCB for applications in PAD and in the treatment of coronary in-stent restenosis (ISR). The employment of DCB in side branch treatment of bifurcation lesions has been reported to be feasible and safe, with good angiographic and clinical outcome. The use of DCB for arteriovenous fistula and grafts stenoses is a promising strategy, but more clinical data is required to draw reliable conclusions. The limitations and impact of the current generation of DCBs will be discussed and the clinical development of newer generation of the device is also covered in this review. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-coated balloons: Technologies and clinical applications ###Abstract: The progress and development of drug-coated balloons (DCBs) represents an emerging alternative treatment in peripheral and coronary artery diseases, particularly when a non-stent approach is necessary. Several studies and meta-analyses have evaluated the clinical outcomes of DCBs in different lesions and this review aims to compile the progress and updated clinical data of DCB strategy in both peripheral artery diseases (PAD) and coronary artery diseases (CAD). The review highlights that clinical data has encouraged the use of DCB for applications in PAD and in the treatment of coronary in-stent restenosis (ISR). The employment of DCB in side branch treatment of bifurcation lesions has been reported to be feasible and safe, with good angiographic and clinical outcome. The use of DCB for arteriovenous fistula and grafts stenoses is a promising strategy, but more clinical data is required to draw reliable conclusions. The limitations and impact of the current generation of DCBs will be discussed and the clinical development of newer generation of the device is also covered in this review. [/INST] Exclude </s>
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Armstrong 2016
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Late breaking trials of 2015 in structural heart disease and peripheral artery disease: Commentary covering ACC, EuroPCR, SCAI, TCT, VIVA, ESC, and AHA
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With the large number of late breaking clinical trials presented at major meetings, it is often difficult to stay current with advances in interventional cardiology. Therefore, the SCAI Publications Committee summarizes and provides editorial commentary on the most important structural heart and peripheral artery disease late-breaking trials from 2015.
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Exclude
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DE12 - Wrong Article Type
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Late breaking trials of 2015 in structural heart disease and peripheral artery disease: Commentary covering ACC, EuroPCR, SCAI, TCT, VIVA, ESC, and AHA ###Abstract: With the large number of late breaking clinical trials presented at major meetings, it is often difficult to stay current with advances in interventional cardiology. Therefore, the SCAI Publications Committee summarizes and provides editorial commentary on the most important structural heart and peripheral artery disease late-breaking trials from 2015. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Late breaking trials of 2015 in structural heart disease and peripheral artery disease: Commentary covering ACC, EuroPCR, SCAI, TCT, VIVA, ESC, and AHA ###Abstract: With the large number of late breaking clinical trials presented at major meetings, it is often difficult to stay current with advances in interventional cardiology. Therefore, the SCAI Publications Committee summarizes and provides editorial commentary on the most important structural heart and peripheral artery disease late-breaking trials from 2015. [/INST] Exclude </s>
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Barkat 2016
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Drug-eluting balloon catheters for lower limb peripheral arterial disease: The evidence to date
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A significant proportion of patients with severe lower limb peripheral arterial disease require revascularization. Over the past decade, an endovascular-first approach even for complex disease has gained widespread use among vascular specialists. An important limitation of percutaneous transluminal balloon angioplasty or stenting remains the occurrence of restenosis. Drug-coated balloons have emerged as an exciting technology developed to overcome the limitations of standard balloon angioplasty and stenting. Drug-eluting devices inhibit neointimal growth of vascular smooth muscle cells with the potential of preventing restenosis. This review provides a synopsis of the up-to-date evidence on the role of drug-coated balloons in the treatment of lower limb peripheral arterial disease. Bibliographic searches were conducted using MEDLINE, EMBASE, and the Cochrane Library electronic database. Eleven randomized clinical trials, two systematic reviews, and a published registry providing the best available evidence were identified. Current evidence suggests that angioplasty with drug-coated balloon is reliable, safe, and efficient in increasing patency rates and reducing target lesion revascularization and restenosis. However, it remains unknown whether these improved results can translate into beneficial clinical outcomes, as current randomized clinical trials have failed to demonstrate a significant benefit in limb salvage and mortality. Further randomized trials focusing on clinical and functional outcomes of drug-eluting balloons and on cost versus clinical benefit are required.
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Exclude
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DE12 - Wrong Article Type
|
<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-eluting balloon catheters for lower limb peripheral arterial disease: The evidence to date ###Abstract: A significant proportion of patients with severe lower limb peripheral arterial disease require revascularization. Over the past decade, an endovascular-first approach even for complex disease has gained widespread use among vascular specialists. An important limitation of percutaneous transluminal balloon angioplasty or stenting remains the occurrence of restenosis. Drug-coated balloons have emerged as an exciting technology developed to overcome the limitations of standard balloon angioplasty and stenting. Drug-eluting devices inhibit neointimal growth of vascular smooth muscle cells with the potential of preventing restenosis. This review provides a synopsis of the up-to-date evidence on the role of drug-coated balloons in the treatment of lower limb peripheral arterial disease. Bibliographic searches were conducted using MEDLINE, EMBASE, and the Cochrane Library electronic database. Eleven randomized clinical trials, two systematic reviews, and a published registry providing the best available evidence were identified. Current evidence suggests that angioplasty with drug-coated balloon is reliable, safe, and efficient in increasing patency rates and reducing target lesion revascularization and restenosis. However, it remains unknown whether these improved results can translate into beneficial clinical outcomes, as current randomized clinical trials have failed to demonstrate a significant benefit in limb salvage and mortality. Further randomized trials focusing on clinical and functional outcomes of drug-eluting balloons and on cost versus clinical benefit are required. [/INST]
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Drug-eluting balloon catheters for lower limb peripheral arterial disease: The evidence to date ###Abstract: A significant proportion of patients with severe lower limb peripheral arterial disease require revascularization. Over the past decade, an endovascular-first approach even for complex disease has gained widespread use among vascular specialists. An important limitation of percutaneous transluminal balloon angioplasty or stenting remains the occurrence of restenosis. Drug-coated balloons have emerged as an exciting technology developed to overcome the limitations of standard balloon angioplasty and stenting. Drug-eluting devices inhibit neointimal growth of vascular smooth muscle cells with the potential of preventing restenosis. This review provides a synopsis of the up-to-date evidence on the role of drug-coated balloons in the treatment of lower limb peripheral arterial disease. Bibliographic searches were conducted using MEDLINE, EMBASE, and the Cochrane Library electronic database. Eleven randomized clinical trials, two systematic reviews, and a published registry providing the best available evidence were identified. Current evidence suggests that angioplasty with drug-coated balloon is reliable, safe, and efficient in increasing patency rates and reducing target lesion revascularization and restenosis. However, it remains unknown whether these improved results can translate into beneficial clinical outcomes, as current randomized clinical trials have failed to demonstrate a significant benefit in limb salvage and mortality. Further randomized trials focusing on clinical and functional outcomes of drug-eluting balloons and on cost versus clinical benefit are required. [/INST] Exclude </s>
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Basavarajaiah 2016
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Treatment of drug-eluting stent restenosis: Comparison between drug-eluting balloon versus second-generation drug-eluting stents from a retrospective observational study
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Objectives: To compare drug-eluting balloons (DEBs) versus second-generation DES in the treatment of drug-eluting stent restenosis (DES-ISR). Background: The optimal treatment of DES-ISR remains unclear. Several modes of treatment ranging from plain-old balloon angioplasty to repeated use of DES have yielded disappointing results. DEBs are increasingly been used in restenotic lesions; however, their use in DES-ISR is less established. Methods: We evaluated all procedures between 2009 and 2011, involving DES-ISR that were treated either with DEB or second-generation DES. The measured end-points during the follow-up period were cardiac-death, target-vessel MI, TLR, TVR, and MACE defined as composite of cardiac-death, TV-MI, and TVR. Results: Two hundred and forty-seven patients (302 lesions) with DES-ISR were treated with either DEB (81 patients; 104 lesions) or second-generation DES (166 patients; 198 lesions). The mean age of patients was 66.1 ± 9.4 years. There were higher numbers of patients with diabetes in the DEB group (DEB 47% vs DES 33%; p = 0.03). The mean length of DEB was significantly longer than the DES (35.4 vs 19.8 mm; p < 0.001). During the 12-month follow-up, there were no significant differences in the MACE rates (12.3% vs 8.4%; p = 0.3) and TLR rates (9.9% vs 7.8%; p = 0.6) between DEB and DES, respectively. On the multivariate analysis, use of DEB or DES was not the predictor of MACE (hazard ratio: 0.84, 95% CI: 0.46–1.85; p = 0.6). There were no cases of definite or probable stent thrombosis in either group. Conclusion: There were no significant differences in the clinical outcomes between DEB and second-generation DES in the treatment of DES-ISR. These results should encourage operators to consider DEB in the treatment of DES-ISR, which offers certain advantages over DES. © 2015 Wiley Periodicals, Inc.
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Exclude
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DE2 - Wrong Topic
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<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Treatment of drug-eluting stent restenosis: Comparison between drug-eluting balloon versus second-generation drug-eluting stents from a retrospective observational study ###Abstract: Objectives: To compare drug-eluting balloons (DEBs) versus second-generation DES in the treatment of drug-eluting stent restenosis (DES-ISR). Background: The optimal treatment of DES-ISR remains unclear. Several modes of treatment ranging from plain-old balloon angioplasty to repeated use of DES have yielded disappointing results. DEBs are increasingly been used in restenotic lesions; however, their use in DES-ISR is less established. Methods: We evaluated all procedures between 2009 and 2011, involving DES-ISR that were treated either with DEB or second-generation DES. The measured end-points during the follow-up period were cardiac-death, target-vessel MI, TLR, TVR, and MACE defined as composite of cardiac-death, TV-MI, and TVR. Results: Two hundred and forty-seven patients (302 lesions) with DES-ISR were treated with either DEB (81 patients; 104 lesions) or second-generation DES (166 patients; 198 lesions). The mean age of patients was 66.1 ± 9.4 years. There were higher numbers of patients with diabetes in the DEB group (DEB 47% vs DES 33%; p = 0.03). The mean length of DEB was significantly longer than the DES (35.4 vs 19.8 mm; p < 0.001). During the 12-month follow-up, there were no significant differences in the MACE rates (12.3% vs 8.4%; p = 0.3) and TLR rates (9.9% vs 7.8%; p = 0.6) between DEB and DES, respectively. On the multivariate analysis, use of DEB or DES was not the predictor of MACE (hazard ratio: 0.84, 95% CI: 0.46–1.85; p = 0.6). There were no cases of definite or probable stent thrombosis in either group. Conclusion: There were no significant differences in the clinical outcomes between DEB and second-generation DES in the treatment of DES-ISR. These results should encourage operators to consider DEB in the treatment of DES-ISR, which offers certain advantages over DES. © 2015 Wiley Periodicals, Inc. [/INST]
|
<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Treatment of drug-eluting stent restenosis: Comparison between drug-eluting balloon versus second-generation drug-eluting stents from a retrospective observational study ###Abstract: Objectives: To compare drug-eluting balloons (DEBs) versus second-generation DES in the treatment of drug-eluting stent restenosis (DES-ISR). Background: The optimal treatment of DES-ISR remains unclear. Several modes of treatment ranging from plain-old balloon angioplasty to repeated use of DES have yielded disappointing results. DEBs are increasingly been used in restenotic lesions; however, their use in DES-ISR is less established. Methods: We evaluated all procedures between 2009 and 2011, involving DES-ISR that were treated either with DEB or second-generation DES. The measured end-points during the follow-up period were cardiac-death, target-vessel MI, TLR, TVR, and MACE defined as composite of cardiac-death, TV-MI, and TVR. Results: Two hundred and forty-seven patients (302 lesions) with DES-ISR were treated with either DEB (81 patients; 104 lesions) or second-generation DES (166 patients; 198 lesions). The mean age of patients was 66.1 ± 9.4 years. There were higher numbers of patients with diabetes in the DEB group (DEB 47% vs DES 33%; p = 0.03). The mean length of DEB was significantly longer than the DES (35.4 vs 19.8 mm; p < 0.001). During the 12-month follow-up, there were no significant differences in the MACE rates (12.3% vs 8.4%; p = 0.3) and TLR rates (9.9% vs 7.8%; p = 0.6) between DEB and DES, respectively. On the multivariate analysis, use of DEB or DES was not the predictor of MACE (hazard ratio: 0.84, 95% CI: 0.46–1.85; p = 0.6). There were no cases of definite or probable stent thrombosis in either group. Conclusion: There were no significant differences in the clinical outcomes between DEB and second-generation DES in the treatment of DES-ISR. These results should encourage operators to consider DEB in the treatment of DES-ISR, which offers certain advantages over DES. © 2015 Wiley Periodicals, Inc. [/INST] Exclude </s>
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Benezet 2016
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Comparison of two different drug-coated balloons for the treatment of in-stent restenosis: A long-term single-centre experience
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Objectives: We aim to evaluate the long-term efficacy of two different paclitaxel-coated balloons (PCBs) for the treatment of coronary in-stent restenosis (ISR). Methods: Between February 2011 and February 2012, all consecutive patients with ISR lesions treated with the SeQuent® Please (B. Braun, Melsungen, Germany) PCB or with the DIOR® (Eurocor GmbH, Bonn, Germany) PCB at our institution were prospectively included and followed up for 36 months by clinical observation. The primary endpoint was the clinically driven target lesion revascularization (TLR) rate at 36 months. Results: 65 patients with 74 ISR lesions were included. 43 ISR lesions were treated with the SeQuent® Please PCB and 31 with the DIOR® PCB. Baseline clinical, lesion characteristics and procedural data did not significantly differ between the groups. The TLR rate was significantly lower in patients treated with the SeQuent® Please PCB compared with the DIOR® PCB (4.7% vs. 22. 6%, p = 0.03) at 36 months. Conclusions: This registry suggests that there are differences in terms of TLR between two clinically available PCBs. The SeQuent® Please PCB demonstrated lower TLR rate compared to the DIOR® PCB at 36 months follow up.
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Exclude
|
DE1 - Incorrect Device
|
<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Comparison of two different drug-coated balloons for the treatment of in-stent restenosis: A long-term single-centre experience ###Abstract: Objectives: We aim to evaluate the long-term efficacy of two different paclitaxel-coated balloons (PCBs) for the treatment of coronary in-stent restenosis (ISR). Methods: Between February 2011 and February 2012, all consecutive patients with ISR lesions treated with the SeQuent® Please (B. Braun, Melsungen, Germany) PCB or with the DIOR® (Eurocor GmbH, Bonn, Germany) PCB at our institution were prospectively included and followed up for 36 months by clinical observation. The primary endpoint was the clinically driven target lesion revascularization (TLR) rate at 36 months. Results: 65 patients with 74 ISR lesions were included. 43 ISR lesions were treated with the SeQuent® Please PCB and 31 with the DIOR® PCB. Baseline clinical, lesion characteristics and procedural data did not significantly differ between the groups. The TLR rate was significantly lower in patients treated with the SeQuent® Please PCB compared with the DIOR® PCB (4.7% vs. 22. 6%, p = 0.03) at 36 months. Conclusions: This registry suggests that there are differences in terms of TLR between two clinically available PCBs. The SeQuent® Please PCB demonstrated lower TLR rate compared to the DIOR® PCB at 36 months follow up. [/INST]
|
<s>[INST] Below is the title and abstract of a medical literature, and its class of being included or excluded for analysis. Use these data to build a classification model to tell if the literature is included or excluded. Answer with Include or Exclude only. ###Title: Comparison of two different drug-coated balloons for the treatment of in-stent restenosis: A long-term single-centre experience ###Abstract: Objectives: We aim to evaluate the long-term efficacy of two different paclitaxel-coated balloons (PCBs) for the treatment of coronary in-stent restenosis (ISR). Methods: Between February 2011 and February 2012, all consecutive patients with ISR lesions treated with the SeQuent® Please (B. Braun, Melsungen, Germany) PCB or with the DIOR® (Eurocor GmbH, Bonn, Germany) PCB at our institution were prospectively included and followed up for 36 months by clinical observation. The primary endpoint was the clinically driven target lesion revascularization (TLR) rate at 36 months. Results: 65 patients with 74 ISR lesions were included. 43 ISR lesions were treated with the SeQuent® Please PCB and 31 with the DIOR® PCB. Baseline clinical, lesion characteristics and procedural data did not significantly differ between the groups. The TLR rate was significantly lower in patients treated with the SeQuent® Please PCB compared with the DIOR® PCB (4.7% vs. 22. 6%, p = 0.03) at 36 months. Conclusions: This registry suggests that there are differences in terms of TLR between two clinically available PCBs. The SeQuent® Please PCB demonstrated lower TLR rate compared to the DIOR® PCB at 36 months follow up. [/INST] Exclude </s>
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