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Bhatia 2020
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Drug-Eluting Balloon Angioplasty for In-Stent Restenosis Following Carotid Artery Stent Placement
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BACKGROUND AND PURPOSE: Drug-eluting balloons (DEBs) have been proposed as an option for the treatment of in-stent restenosis (ISR) following carotid artery stent placement. We report our experience and review of literature to provide additional data. METHODS: For literature review, PubMed search was conducted to identify studies published between 2005 and 2019, reporting data on management of carotid ISR with DEBs. Two cases with carotid ISR, which were successfully treated with DEB at our facility, were also included in the final compilation of results. RESULTS: A total of seven studies demonstrating the use of the DEBs for treatment of carotid ISR were identified. They encompassed 31 patients, 11 (35.5%) of whom presented with symptomatic ISR, with the remaining 20 patients (64.5%) asymptomatic. DEB angioplasty followed by stent placement was performed in 3 patients, whereas DEB alone was utilized in 28 patients. Periprocedural complications included asymptomatic dissection from DEB inflation in 1 patient and transient neurological deficits in another patient. Follow-up period was variable and ranged from 1 month to 5 years. Three patients were noted to develop recurrent asymptomatic stenosis, whereas 1 patient developed an episode of symptomatic restenosis post procedural on follow-up. In our two cases, both patients were noted to have protracted period of hypotension postprocedure without any new or recurrent neurological symptoms. CONCLUSION: The use of DEBs is a promising development and a viable alternative for management of severe and recurrent carotid ISR.
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Exclude
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DE9 - Unavailable
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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 Angioplasty for In-Stent Restenosis Following Carotid Artery Stent Placement ###Abstract: BACKGROUND AND PURPOSE: Drug-eluting balloons (DEBs) have been proposed as an option for the treatment of in-stent restenosis (ISR) following carotid artery stent placement. We report our experience and review of literature to provide additional data. METHODS: For literature review, PubMed search was conducted to identify studies published between 2005 and 2019, reporting data on management of carotid ISR with DEBs. Two cases with carotid ISR, which were successfully treated with DEB at our facility, were also included in the final compilation of results. RESULTS: A total of seven studies demonstrating the use of the DEBs for treatment of carotid ISR were identified. They encompassed 31 patients, 11 (35.5%) of whom presented with symptomatic ISR, with the remaining 20 patients (64.5%) asymptomatic. DEB angioplasty followed by stent placement was performed in 3 patients, whereas DEB alone was utilized in 28 patients. Periprocedural complications included asymptomatic dissection from DEB inflation in 1 patient and transient neurological deficits in another patient. Follow-up period was variable and ranged from 1 month to 5 years. Three patients were noted to develop recurrent asymptomatic stenosis, whereas 1 patient developed an episode of symptomatic restenosis post procedural on follow-up. In our two cases, both patients were noted to have protracted period of hypotension postprocedure without any new or recurrent neurological symptoms. CONCLUSION: The use of DEBs is a promising development and a viable alternative for management of severe and recurrent carotid ISR. [/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: Drug-Eluting Balloon Angioplasty for In-Stent Restenosis Following Carotid Artery Stent Placement ###Abstract: BACKGROUND AND PURPOSE: Drug-eluting balloons (DEBs) have been proposed as an option for the treatment of in-stent restenosis (ISR) following carotid artery stent placement. We report our experience and review of literature to provide additional data. METHODS: For literature review, PubMed search was conducted to identify studies published between 2005 and 2019, reporting data on management of carotid ISR with DEBs. Two cases with carotid ISR, which were successfully treated with DEB at our facility, were also included in the final compilation of results. RESULTS: A total of seven studies demonstrating the use of the DEBs for treatment of carotid ISR were identified. They encompassed 31 patients, 11 (35.5%) of whom presented with symptomatic ISR, with the remaining 20 patients (64.5%) asymptomatic. DEB angioplasty followed by stent placement was performed in 3 patients, whereas DEB alone was utilized in 28 patients. Periprocedural complications included asymptomatic dissection from DEB inflation in 1 patient and transient neurological deficits in another patient. Follow-up period was variable and ranged from 1 month to 5 years. Three patients were noted to develop recurrent asymptomatic stenosis, whereas 1 patient developed an episode of symptomatic restenosis post procedural on follow-up. In our two cases, both patients were noted to have protracted period of hypotension postprocedure without any new or recurrent neurological symptoms. CONCLUSION: The use of DEBs is a promising development and a viable alternative for management of severe and recurrent carotid ISR. [/INST] Exclude </s>
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Biscaglia 2019
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Angina and left ventricular dysfunction: Can we 'reduce' it?
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Despite the evolution in pharmacology and devices, recurrent and persistent angina still represent a frequent issue in clinical practice. A 69-year-old Caucasian female patient has history of surgical aortic valve replacement with a bioprosthesis for severe aortic stenosis with subsequent transcatheter valve-in-valve implantation for bioprosthesis degeneration and single coronary artery bypass graft with left internal mammary artery on left anterior descending (LAD). After transcatheter aortic valve implantation, she started to complain angina [Canadian Cardiovascular Society (CCS) Class III], effectively treated with bisoprolol uptitration and ivabradine 5 b.i.d. addition. After 6 months, she had a non-ST segment elevated myocardial infarction with evidence of left main occlusion and good functioning aortic bioprosthesis. A retrograde drug-eluting balloon percutaneous coronary intervention (PCI) on LAD (in-stent restenosis) was performed. However, the patient continued to complain angina (CCS Class II-III), even after further ivabradine increase to 7.5 mg b.i.d. After 4 months, the patient underwent Reducer implantation. After 2 months, angina started to improve and the patient is currently angina free. In the last decades, PCI materials and stents greatly improved. Medical therapy (such as b-blockers) has been shown not only to improve symptoms but also to add a prognostic benefit in patients with reduced ejection fraction (EF). Ivabradine showed additional benefits in patients with angina and reduced EF. However, still a relevant portion of patients complain refractory angina. The COSIRA trial showed that a coronary sinus Reducer was associated with greater angina relief than the sham procedure and could be a further step in angina treatment.
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Exclude
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DE7 - Device not mentioned
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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: Angina and left ventricular dysfunction: Can we 'reduce' it? ###Abstract: Despite the evolution in pharmacology and devices, recurrent and persistent angina still represent a frequent issue in clinical practice. A 69-year-old Caucasian female patient has history of surgical aortic valve replacement with a bioprosthesis for severe aortic stenosis with subsequent transcatheter valve-in-valve implantation for bioprosthesis degeneration and single coronary artery bypass graft with left internal mammary artery on left anterior descending (LAD). After transcatheter aortic valve implantation, she started to complain angina [Canadian Cardiovascular Society (CCS) Class III], effectively treated with bisoprolol uptitration and ivabradine 5 b.i.d. addition. After 6 months, she had a non-ST segment elevated myocardial infarction with evidence of left main occlusion and good functioning aortic bioprosthesis. A retrograde drug-eluting balloon percutaneous coronary intervention (PCI) on LAD (in-stent restenosis) was performed. However, the patient continued to complain angina (CCS Class II-III), even after further ivabradine increase to 7.5 mg b.i.d. After 4 months, the patient underwent Reducer implantation. After 2 months, angina started to improve and the patient is currently angina free. In the last decades, PCI materials and stents greatly improved. Medical therapy (such as b-blockers) has been shown not only to improve symptoms but also to add a prognostic benefit in patients with reduced ejection fraction (EF). Ivabradine showed additional benefits in patients with angina and reduced EF. However, still a relevant portion of patients complain refractory angina. The COSIRA trial showed that a coronary sinus Reducer was associated with greater angina relief than the sham procedure and could be a further step in angina treatment. [/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: Angina and left ventricular dysfunction: Can we 'reduce' it? ###Abstract: Despite the evolution in pharmacology and devices, recurrent and persistent angina still represent a frequent issue in clinical practice. A 69-year-old Caucasian female patient has history of surgical aortic valve replacement with a bioprosthesis for severe aortic stenosis with subsequent transcatheter valve-in-valve implantation for bioprosthesis degeneration and single coronary artery bypass graft with left internal mammary artery on left anterior descending (LAD). After transcatheter aortic valve implantation, she started to complain angina [Canadian Cardiovascular Society (CCS) Class III], effectively treated with bisoprolol uptitration and ivabradine 5 b.i.d. addition. After 6 months, she had a non-ST segment elevated myocardial infarction with evidence of left main occlusion and good functioning aortic bioprosthesis. A retrograde drug-eluting balloon percutaneous coronary intervention (PCI) on LAD (in-stent restenosis) was performed. However, the patient continued to complain angina (CCS Class II-III), even after further ivabradine increase to 7.5 mg b.i.d. After 4 months, the patient underwent Reducer implantation. After 2 months, angina started to improve and the patient is currently angina free. In the last decades, PCI materials and stents greatly improved. Medical therapy (such as b-blockers) has been shown not only to improve symptoms but also to add a prognostic benefit in patients with reduced ejection fraction (EF). Ivabradine showed additional benefits in patients with angina and reduced EF. However, still a relevant portion of patients complain refractory angina. The COSIRA trial showed that a coronary sinus Reducer was associated with greater angina relief than the sham procedure and could be a further step in angina treatment. [/INST] Exclude </s>
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Bisdas 2018
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1-Year All-Comers Analysis of the Eluvia Drug-Eluting Stent for Long Femoropopliteal Lesions After Suboptimal Angioplasty
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Objectives: The aim of this study was to assess the performance of the fluoropolymer-based paclitaxel-eluting stent (PES) in long femoropopliteal lesions. Background: The new-generation fluoropolymer-based PES showed promising outcomes in short femoropopliteal lesions. The main feature of the stent is its controlled and sustained paclitaxel release over 12 months. However, the safety and efficacy of this technology in longer femoropopliteal lesions remain unclear. Methods: Between March 2016 and March 2017, 62 patients were included in this analysis. Indications for fluoropolymer-based PES deployment were insufficient luminal gain or flow-limiting dissection after plain old balloon angioplasty in a femoropopliteal lesion. Primary patency, freedom from target lesion revascularization, amputation-free survival, and paclitaxel-related adverse events were retrospectively analyzed for up to 1 year of follow-up. Results: Lesions were de novo in 84% of patients. Mean lesion length was 20 ± 12 cm, and 79% of the lesions (n = 49) were chronic total occlusions. Moderate or severe calcification was present in 42% of the lesions (n = 26). Stent implantation involved the distal superficial femoral artery and the proximal popliteal artery in 76% (n = 47) and 44% (n = 27) of patients, respectively. The Kaplan-Meier estimate of primary patency and freedom from target lesion revascularization was 87%. Amputation-free survival was 100% for patients with claudication (n = 32 [52%]) and 87% in patients with critical limb ischemia (n = 30 [48%]) (hazard ratio: 6.3; 95% confidence interval: 1.25 to 31.54; p = 0.052). Five aneurysm formations of the treated segments (8%) were thought to be attributable to paclitaxel. Conclusions: The fluoropolymer-based PES showed promising 1-year clinical and angiographic outcomes in real-world long femoropopliteal lesions. The long-term impact of aneurysm formation remains to be further investigated.
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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: 1-Year All-Comers Analysis of the Eluvia Drug-Eluting Stent for Long Femoropopliteal Lesions After Suboptimal Angioplasty ###Abstract: Objectives: The aim of this study was to assess the performance of the fluoropolymer-based paclitaxel-eluting stent (PES) in long femoropopliteal lesions. Background: The new-generation fluoropolymer-based PES showed promising outcomes in short femoropopliteal lesions. The main feature of the stent is its controlled and sustained paclitaxel release over 12 months. However, the safety and efficacy of this technology in longer femoropopliteal lesions remain unclear. Methods: Between March 2016 and March 2017, 62 patients were included in this analysis. Indications for fluoropolymer-based PES deployment were insufficient luminal gain or flow-limiting dissection after plain old balloon angioplasty in a femoropopliteal lesion. Primary patency, freedom from target lesion revascularization, amputation-free survival, and paclitaxel-related adverse events were retrospectively analyzed for up to 1 year of follow-up. Results: Lesions were de novo in 84% of patients. Mean lesion length was 20 ± 12 cm, and 79% of the lesions (n = 49) were chronic total occlusions. Moderate or severe calcification was present in 42% of the lesions (n = 26). Stent implantation involved the distal superficial femoral artery and the proximal popliteal artery in 76% (n = 47) and 44% (n = 27) of patients, respectively. The Kaplan-Meier estimate of primary patency and freedom from target lesion revascularization was 87%. Amputation-free survival was 100% for patients with claudication (n = 32 [52%]) and 87% in patients with critical limb ischemia (n = 30 [48%]) (hazard ratio: 6.3; 95% confidence interval: 1.25 to 31.54; p = 0.052). Five aneurysm formations of the treated segments (8%) were thought to be attributable to paclitaxel. Conclusions: The fluoropolymer-based PES showed promising 1-year clinical and angiographic outcomes in real-world long femoropopliteal lesions. The long-term impact of aneurysm formation remains to be further investigated. [/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 All-Comers Analysis of the Eluvia Drug-Eluting Stent for Long Femoropopliteal Lesions After Suboptimal Angioplasty ###Abstract: Objectives: The aim of this study was to assess the performance of the fluoropolymer-based paclitaxel-eluting stent (PES) in long femoropopliteal lesions. Background: The new-generation fluoropolymer-based PES showed promising outcomes in short femoropopliteal lesions. The main feature of the stent is its controlled and sustained paclitaxel release over 12 months. However, the safety and efficacy of this technology in longer femoropopliteal lesions remain unclear. Methods: Between March 2016 and March 2017, 62 patients were included in this analysis. Indications for fluoropolymer-based PES deployment were insufficient luminal gain or flow-limiting dissection after plain old balloon angioplasty in a femoropopliteal lesion. Primary patency, freedom from target lesion revascularization, amputation-free survival, and paclitaxel-related adverse events were retrospectively analyzed for up to 1 year of follow-up. Results: Lesions were de novo in 84% of patients. Mean lesion length was 20 ± 12 cm, and 79% of the lesions (n = 49) were chronic total occlusions. Moderate or severe calcification was present in 42% of the lesions (n = 26). Stent implantation involved the distal superficial femoral artery and the proximal popliteal artery in 76% (n = 47) and 44% (n = 27) of patients, respectively. The Kaplan-Meier estimate of primary patency and freedom from target lesion revascularization was 87%. Amputation-free survival was 100% for patients with claudication (n = 32 [52%]) and 87% in patients with critical limb ischemia (n = 30 [48%]) (hazard ratio: 6.3; 95% confidence interval: 1.25 to 31.54; p = 0.052). Five aneurysm formations of the treated segments (8%) were thought to be attributable to paclitaxel. Conclusions: The fluoropolymer-based PES showed promising 1-year clinical and angiographic outcomes in real-world long femoropopliteal lesions. The long-term impact of aneurysm formation remains to be further investigated. [/INST] Exclude </s>
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Bolt 2019
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Duplex-guided versus Conventional Percutaneous Transluminal Angioplasty of Iliac TASC II A and B Lesion: A Randomized Controlled Trial
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Background: Percutaneous transluminal angioplasty (PTA) requires the use of nephrotoxic contrast. Patients with chronic kidney disease are more prone to develop contrast-induced nephropathy after utilization of contrast. Doppler ultrasound (duplex)-guided PTA (DuPTA) is a novel technique and has recently proven to be a successful alternative to conventional PTA in the treatment of iliac stenotic disease, without the use of contrast. In this randomized controlled trial, we evaluated whether DuPTA is as effective as conventional PTA in the treatment of iliac arterial stenotic disease. Methods: From June 2013 till January 2017, 142 patients with symptomatic peripheral arterial disease (PAD), with significant (>70%) iliac stenotic lesions (both isolated and patients with multilevel disease without treatment of other lesions), were randomized to receive either conventional PTA or DuPTA of the iliac lesion, regardless of renal function. All patients received an ankle–brachial index, arterial mapping with duplex, and magnetic resonance angiography in the pre-operative work-up. Primary end point was procedural success, defined as passing the guidewire through the stenotic lesion and performing a PTA, with or without stenting. Reduction in peak systolic velocity (PSV) of ≥50% after successful PTA was required in the DuPTA group. Angiographic reduction of more than 50% was required in the interventional group. Decrease in PSV was evaluated in both groups 4 weeks post-procedure. Results: Passing of the guidewire through the stenotic lesion was achieved in 96.5% of the DuPTA group and 98.8% of the PTA group (P = 0.34). Although PSV decreased significantly in both groups 4 weeks post-operative, PSV reduction ≥50% was significantly higher in the DuPTA group, respectively 78% vs. 58% in the PTA group (P < 0.01). The utilization of stents was significantly greater in the DuPTA group (52% vs. 18%, P < 0.01). After correction of potential confounders, significant difference in ≥50% PSV reduction remained; technical success did not differ significantly. Conclusions: DuPTA is a feasible alternative to conventional PTA in the treatment of PAD on the iliac anatomic level. Duplex examination before removal of the guidewire is recommended to evaluate adequate decrease in PSV and identify potential recoil.
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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: Duplex-guided versus Conventional Percutaneous Transluminal Angioplasty of Iliac TASC II A and B Lesion: A Randomized Controlled Trial ###Abstract: Background: Percutaneous transluminal angioplasty (PTA) requires the use of nephrotoxic contrast. Patients with chronic kidney disease are more prone to develop contrast-induced nephropathy after utilization of contrast. Doppler ultrasound (duplex)-guided PTA (DuPTA) is a novel technique and has recently proven to be a successful alternative to conventional PTA in the treatment of iliac stenotic disease, without the use of contrast. In this randomized controlled trial, we evaluated whether DuPTA is as effective as conventional PTA in the treatment of iliac arterial stenotic disease. Methods: From June 2013 till January 2017, 142 patients with symptomatic peripheral arterial disease (PAD), with significant (>70%) iliac stenotic lesions (both isolated and patients with multilevel disease without treatment of other lesions), were randomized to receive either conventional PTA or DuPTA of the iliac lesion, regardless of renal function. All patients received an ankle–brachial index, arterial mapping with duplex, and magnetic resonance angiography in the pre-operative work-up. Primary end point was procedural success, defined as passing the guidewire through the stenotic lesion and performing a PTA, with or without stenting. Reduction in peak systolic velocity (PSV) of ≥50% after successful PTA was required in the DuPTA group. Angiographic reduction of more than 50% was required in the interventional group. Decrease in PSV was evaluated in both groups 4 weeks post-procedure. Results: Passing of the guidewire through the stenotic lesion was achieved in 96.5% of the DuPTA group and 98.8% of the PTA group (P = 0.34). Although PSV decreased significantly in both groups 4 weeks post-operative, PSV reduction ≥50% was significantly higher in the DuPTA group, respectively 78% vs. 58% in the PTA group (P < 0.01). The utilization of stents was significantly greater in the DuPTA group (52% vs. 18%, P < 0.01). After correction of potential confounders, significant difference in ≥50% PSV reduction remained; technical success did not differ significantly. Conclusions: DuPTA is a feasible alternative to conventional PTA in the treatment of PAD on the iliac anatomic level. Duplex examination before removal of the guidewire is recommended to evaluate adequate decrease in PSV and identify potential recoil. [/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: Duplex-guided versus Conventional Percutaneous Transluminal Angioplasty of Iliac TASC II A and B Lesion: A Randomized Controlled Trial ###Abstract: Background: Percutaneous transluminal angioplasty (PTA) requires the use of nephrotoxic contrast. Patients with chronic kidney disease are more prone to develop contrast-induced nephropathy after utilization of contrast. Doppler ultrasound (duplex)-guided PTA (DuPTA) is a novel technique and has recently proven to be a successful alternative to conventional PTA in the treatment of iliac stenotic disease, without the use of contrast. In this randomized controlled trial, we evaluated whether DuPTA is as effective as conventional PTA in the treatment of iliac arterial stenotic disease. Methods: From June 2013 till January 2017, 142 patients with symptomatic peripheral arterial disease (PAD), with significant (>70%) iliac stenotic lesions (both isolated and patients with multilevel disease without treatment of other lesions), were randomized to receive either conventional PTA or DuPTA of the iliac lesion, regardless of renal function. All patients received an ankle–brachial index, arterial mapping with duplex, and magnetic resonance angiography in the pre-operative work-up. Primary end point was procedural success, defined as passing the guidewire through the stenotic lesion and performing a PTA, with or without stenting. Reduction in peak systolic velocity (PSV) of ≥50% after successful PTA was required in the DuPTA group. Angiographic reduction of more than 50% was required in the interventional group. Decrease in PSV was evaluated in both groups 4 weeks post-procedure. Results: Passing of the guidewire through the stenotic lesion was achieved in 96.5% of the DuPTA group and 98.8% of the PTA group (P = 0.34). Although PSV decreased significantly in both groups 4 weeks post-operative, PSV reduction ≥50% was significantly higher in the DuPTA group, respectively 78% vs. 58% in the PTA group (P < 0.01). The utilization of stents was significantly greater in the DuPTA group (52% vs. 18%, P < 0.01). After correction of potential confounders, significant difference in ≥50% PSV reduction remained; technical success did not differ significantly. Conclusions: DuPTA is a feasible alternative to conventional PTA in the treatment of PAD on the iliac anatomic level. Duplex examination before removal of the guidewire is recommended to evaluate adequate decrease in PSV and identify potential recoil. [/INST] Exclude </s>
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Brahmbhatt 2016
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Techniques in Vascular and Interventional Radiology Drug Delivery Technologies in the Superficial Femoral Artery
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Peripheral arterial disease (PAD) affects over 8 million people in the United States alone. Although great strides have been made in reducing the burden of cardiovascular disease the prevalence of PAD is expected to rise with the age of global population. PAD characterized by narrowing of arterial blood can be asymptomatic or cause limb threatening claudication. It has been classically treated with bypass, but these techniques have been supplanted by endovascular therapy. Plain old balloon angioplasty has been successful in helping revascularize lesions, but its effect has not been durable because of restenosis. This prompted the creation of several technologies aimed at reducing restenosis. These advances slowly improved outcomes and the durability of endovascular management. Among the main tools used in current endovascular practice are drug-delivery devices aimed at inhibiting the inflammatory and proliferative pathways that lead to restenosis. This article examines the current drug-delivery technologies used in the superficial femoral artery.
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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: Techniques in Vascular and Interventional Radiology Drug Delivery Technologies in the Superficial Femoral Artery ###Abstract: Peripheral arterial disease (PAD) affects over 8 million people in the United States alone. Although great strides have been made in reducing the burden of cardiovascular disease the prevalence of PAD is expected to rise with the age of global population. PAD characterized by narrowing of arterial blood can be asymptomatic or cause limb threatening claudication. It has been classically treated with bypass, but these techniques have been supplanted by endovascular therapy. Plain old balloon angioplasty has been successful in helping revascularize lesions, but its effect has not been durable because of restenosis. This prompted the creation of several technologies aimed at reducing restenosis. These advances slowly improved outcomes and the durability of endovascular management. Among the main tools used in current endovascular practice are drug-delivery devices aimed at inhibiting the inflammatory and proliferative pathways that lead to restenosis. This article examines the current drug-delivery technologies used in the superficial femoral artery. [/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: Techniques in Vascular and Interventional Radiology Drug Delivery Technologies in the Superficial Femoral Artery ###Abstract: Peripheral arterial disease (PAD) affects over 8 million people in the United States alone. Although great strides have been made in reducing the burden of cardiovascular disease the prevalence of PAD is expected to rise with the age of global population. PAD characterized by narrowing of arterial blood can be asymptomatic or cause limb threatening claudication. It has been classically treated with bypass, but these techniques have been supplanted by endovascular therapy. Plain old balloon angioplasty has been successful in helping revascularize lesions, but its effect has not been durable because of restenosis. This prompted the creation of several technologies aimed at reducing restenosis. These advances slowly improved outcomes and the durability of endovascular management. Among the main tools used in current endovascular practice are drug-delivery devices aimed at inhibiting the inflammatory and proliferative pathways that lead to restenosis. This article examines the current drug-delivery technologies used in the superficial femoral artery. [/INST] Exclude </s>
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Buccheri 2016
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Drug-Coated Balloon for Instent Restenosis in Patients at High Risk: Another Brick in the Wall of the Challenging Settings for Interventionists
| null |
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: Drug-Coated Balloon for Instent Restenosis in Patients at High Risk: Another Brick in the Wall of the Challenging Settings for Interventionists ###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: Drug-Coated Balloon for Instent Restenosis in Patients at High Risk: Another Brick in the Wall of the Challenging Settings for Interventionists ###Abstract: None [/INST] Exclude </s>
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Bukka 2018
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Drug-eluting balloon: Design, technology and clinical aspects
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A drug-eluting balloon is a non-stent technology in which the effective homogenous delivery of anti-proliferative drugs is processed by the vessel wall through an inflated balloon. This is done to restore luminal vascularity in order to treat atherosclerosis, in-stent restenosis and reduce the risk of late thrombosis without implanting a permanent foreign object. The balloon technology relies on the concept of targeted drug delivery, which helps in the rapid healing of the vessel wall and prevents the proliferation of smooth muscle cells. Several drug eluting devices in the form of coated balloons are currently in clinical use, namely DIOR(®), PACCOCATH(®), SeQuent(®)Please and IN.PACT™. The device varies in terms of the material used for making the balloon, the coating techniques, the choice of coated drug and the release pattern of the drug at the site. This review gives an insight into the evolution, rationale and comparison of the marketed drug-eluting balloons. Here, different coating techniques have been analysed for the application and critical analysis of available DEB technologies, and a technical comparison has been done.
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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: Drug-eluting balloon: Design, technology and clinical aspects ###Abstract: A drug-eluting balloon is a non-stent technology in which the effective homogenous delivery of anti-proliferative drugs is processed by the vessel wall through an inflated balloon. This is done to restore luminal vascularity in order to treat atherosclerosis, in-stent restenosis and reduce the risk of late thrombosis without implanting a permanent foreign object. The balloon technology relies on the concept of targeted drug delivery, which helps in the rapid healing of the vessel wall and prevents the proliferation of smooth muscle cells. Several drug eluting devices in the form of coated balloons are currently in clinical use, namely DIOR(®), PACCOCATH(®), SeQuent(®)Please and IN.PACT™. The device varies in terms of the material used for making the balloon, the coating techniques, the choice of coated drug and the release pattern of the drug at the site. This review gives an insight into the evolution, rationale and comparison of the marketed drug-eluting balloons. Here, different coating techniques have been analysed for the application and critical analysis of available DEB technologies, and a technical comparison has been done. [/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: Design, technology and clinical aspects ###Abstract: A drug-eluting balloon is a non-stent technology in which the effective homogenous delivery of anti-proliferative drugs is processed by the vessel wall through an inflated balloon. This is done to restore luminal vascularity in order to treat atherosclerosis, in-stent restenosis and reduce the risk of late thrombosis without implanting a permanent foreign object. The balloon technology relies on the concept of targeted drug delivery, which helps in the rapid healing of the vessel wall and prevents the proliferation of smooth muscle cells. Several drug eluting devices in the form of coated balloons are currently in clinical use, namely DIOR(®), PACCOCATH(®), SeQuent(®)Please and IN.PACT™. The device varies in terms of the material used for making the balloon, the coating techniques, the choice of coated drug and the release pattern of the drug at the site. This review gives an insight into the evolution, rationale and comparison of the marketed drug-eluting balloons. Here, different coating techniques have been analysed for the application and critical analysis of available DEB technologies, and a technical comparison has been done. [/INST] Exclude </s>
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Bunte 2018
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Next Generation Endovascular Therapies in Peripheral Artery Disease
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Endovascular therapy (EVT) of symptomatic peripheral artery disease (PAD) offers relief of symptoms and enhanced quality of life. Advancements in technique and technology have increased the feasibility and practicality of EVT, which now represents the preferred mode of revascularization over surgical procedures in many centers across the world. In this review, we consider the future of EVT in context of a rapidly expanding population of patients with symptomatic PAD.
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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: Next Generation Endovascular Therapies in Peripheral Artery Disease ###Abstract: Endovascular therapy (EVT) of symptomatic peripheral artery disease (PAD) offers relief of symptoms and enhanced quality of life. Advancements in technique and technology have increased the feasibility and practicality of EVT, which now represents the preferred mode of revascularization over surgical procedures in many centers across the world. In this review, we consider the future of EVT in context of a rapidly expanding population of patients with symptomatic PAD. [/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: Next Generation Endovascular Therapies in Peripheral Artery Disease ###Abstract: Endovascular therapy (EVT) of symptomatic peripheral artery disease (PAD) offers relief of symptoms and enhanced quality of life. Advancements in technique and technology have increased the feasibility and practicality of EVT, which now represents the preferred mode of revascularization over surgical procedures in many centers across the world. In this review, we consider the future of EVT in context of a rapidly expanding population of patients with symptomatic PAD. [/INST] Exclude </s>
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Cai 2020
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Midterm Outcome of Directional Atherectomy Combined with Drug-Coated Balloon Angioplasty Versus Drug-Coated Balloon Angioplasty Alone for Femoropopliteal Arteriosclerosis Obliterans
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Background: The “leave nothing behind” strategies have been becoming a popular treatment for femoropopliteal arteriosclerosis obliterans. Atherectomy before drug-coated balloon (DCB) angioplasty may have an advantage in improving the efficiency of drug delivery into the blood vessel wall. This study aimed to compare the therapeutic effects of directional atherectomy combined with DCB angioplasty with DCB angioplasty alone in the treatment of femoropopliteal arteriosclerosis obliterans. Methods: Patients with femoropopliteal arteriosclerosis obliterans who received endovascular therapy from June 2016 to June 2018 in our hospital and presented with life-limiting claudication or severe chronic limb ischemia comprised the study cohort. The patients were randomized to receive directional atherectomy combined with DCB angioplasty (n = 45) or DCB alone (n = 49). Ninety-four patients were enrolled in our study with 72 males, and the mean age was 67 ± 10 years. The mean lesion length was 112 ± 64 mm. Results: There were no significant differences in the baseline characteristics of patients and lesions between the 2 randomized groups (P > 0.05). Flow-limiting dissections occurred more frequently in the DCB group (n = 12; 24.5%) than in the DA-DCB group (n = 2; 4.4%; P = 0.006). The technical success rate in the DA-DCB group was superior to that in the DCB group (95.6% vs. 75.5%, P = 0.006). The mean follow-up duration was 16.7 ± 6.1 months in the DCB group and 15.3 ± 5.8 months in the DA-DCB group. No amputations were performed. The overall mortality in the DCB group was 4.1% (2/49), while all patients survived in the DA-DCB group. The 12-month and 24-month primary patencies in the DA-DCB group were greater than those in the DCB group (80.5% vs. 75.7% and 67.1% vs. 55.1%, respectively); however, using all available patency data, no significant differences over time were observed (P = 0.377). Conclusions: In this study, directional atherectomy combined with DCB angioplasty can decrease the flow-limiting dissection rate in the treatment of femoropopliteal arteriosclerosis obliterans compared with DCB angioplasty alone. There was no significant difference between the 2 groups in terms of primary patency rate which was needed to be further clarified.
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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: Midterm Outcome of Directional Atherectomy Combined with Drug-Coated Balloon Angioplasty Versus Drug-Coated Balloon Angioplasty Alone for Femoropopliteal Arteriosclerosis Obliterans ###Abstract: Background: The “leave nothing behind” strategies have been becoming a popular treatment for femoropopliteal arteriosclerosis obliterans. Atherectomy before drug-coated balloon (DCB) angioplasty may have an advantage in improving the efficiency of drug delivery into the blood vessel wall. This study aimed to compare the therapeutic effects of directional atherectomy combined with DCB angioplasty with DCB angioplasty alone in the treatment of femoropopliteal arteriosclerosis obliterans. Methods: Patients with femoropopliteal arteriosclerosis obliterans who received endovascular therapy from June 2016 to June 2018 in our hospital and presented with life-limiting claudication or severe chronic limb ischemia comprised the study cohort. The patients were randomized to receive directional atherectomy combined with DCB angioplasty (n = 45) or DCB alone (n = 49). Ninety-four patients were enrolled in our study with 72 males, and the mean age was 67 ± 10 years. The mean lesion length was 112 ± 64 mm. Results: There were no significant differences in the baseline characteristics of patients and lesions between the 2 randomized groups (P > 0.05). Flow-limiting dissections occurred more frequently in the DCB group (n = 12; 24.5%) than in the DA-DCB group (n = 2; 4.4%; P = 0.006). The technical success rate in the DA-DCB group was superior to that in the DCB group (95.6% vs. 75.5%, P = 0.006). The mean follow-up duration was 16.7 ± 6.1 months in the DCB group and 15.3 ± 5.8 months in the DA-DCB group. No amputations were performed. The overall mortality in the DCB group was 4.1% (2/49), while all patients survived in the DA-DCB group. The 12-month and 24-month primary patencies in the DA-DCB group were greater than those in the DCB group (80.5% vs. 75.7% and 67.1% vs. 55.1%, respectively); however, using all available patency data, no significant differences over time were observed (P = 0.377). Conclusions: In this study, directional atherectomy combined with DCB angioplasty can decrease the flow-limiting dissection rate in the treatment of femoropopliteal arteriosclerosis obliterans compared with DCB angioplasty alone. There was no significant difference between the 2 groups in terms of primary patency rate which was needed to be further clarified. [/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 Outcome of Directional Atherectomy Combined with Drug-Coated Balloon Angioplasty Versus Drug-Coated Balloon Angioplasty Alone for Femoropopliteal Arteriosclerosis Obliterans ###Abstract: Background: The “leave nothing behind” strategies have been becoming a popular treatment for femoropopliteal arteriosclerosis obliterans. Atherectomy before drug-coated balloon (DCB) angioplasty may have an advantage in improving the efficiency of drug delivery into the blood vessel wall. This study aimed to compare the therapeutic effects of directional atherectomy combined with DCB angioplasty with DCB angioplasty alone in the treatment of femoropopliteal arteriosclerosis obliterans. Methods: Patients with femoropopliteal arteriosclerosis obliterans who received endovascular therapy from June 2016 to June 2018 in our hospital and presented with life-limiting claudication or severe chronic limb ischemia comprised the study cohort. The patients were randomized to receive directional atherectomy combined with DCB angioplasty (n = 45) or DCB alone (n = 49). Ninety-four patients were enrolled in our study with 72 males, and the mean age was 67 ± 10 years. The mean lesion length was 112 ± 64 mm. Results: There were no significant differences in the baseline characteristics of patients and lesions between the 2 randomized groups (P > 0.05). Flow-limiting dissections occurred more frequently in the DCB group (n = 12; 24.5%) than in the DA-DCB group (n = 2; 4.4%; P = 0.006). The technical success rate in the DA-DCB group was superior to that in the DCB group (95.6% vs. 75.5%, P = 0.006). The mean follow-up duration was 16.7 ± 6.1 months in the DCB group and 15.3 ± 5.8 months in the DA-DCB group. No amputations were performed. The overall mortality in the DCB group was 4.1% (2/49), while all patients survived in the DA-DCB group. The 12-month and 24-month primary patencies in the DA-DCB group were greater than those in the DCB group (80.5% vs. 75.7% and 67.1% vs. 55.1%, respectively); however, using all available patency data, no significant differences over time were observed (P = 0.377). Conclusions: In this study, directional atherectomy combined with DCB angioplasty can decrease the flow-limiting dissection rate in the treatment of femoropopliteal arteriosclerosis obliterans compared with DCB angioplasty alone. There was no significant difference between the 2 groups in terms of primary patency rate which was needed to be further clarified. [/INST] Exclude </s>
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Caradu 2016
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The management of below-the-knee arterial critical ischemia: Update, systematic review and meta-analysis
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INTRODUCTION: Percutaneous transluminal angioplasty (PTA), with bailout bare metal stenting (BMS) is currently the treatment of choice in below the knee (BTK) lesions, as drug eluting stents '(DESs) results on limb salvage remain controversial. EVIDENCE ACQUISITION: The present review and meta-analysis was carried out based on a PubMed (Medline), Embase and CENTRALsearch to determine the results of the different strategies available to date in the BTK area and to help select an optimized endovascular approach. EVIDENCE SYNTHESIS: DESs significantly decreased the risk of target lesion revascularization (TLR) compared to BMSs (9.7% vs. 29.0%; OR: 0.26; 95% CI: 0.15-0.46; P<0.00001) and the risk of in-segment binary restenosis compared to PTA(21.9% vs. 41.7%; OR: 0.38; 95%CI: 0.23-0.63; p=0.0002), BMSs (19.9% vs. 50.3%; OR: 0.25; 95%CI: 0.15-0.39; P<0.00001) or DEBs (28% vs. 57.9%; p=0.046). Primary patency was significantly improved compared to PTA (64.9% vs. 49.3%; OR: 0.48; 95% CI: 0.29 to 0.77; P=0.003) or BMSs (85.6% vs. 63.9%; OR: 0.26; 95% CI: 0.14 to 0.49; P<0.0001). There was no significant difference in terms of major amputation rate, Rutherford Class (RC) improvement or mortality. CONCLUSIONS: About 35% of BTK lesions are long lesions (5-20 cm) and are best treated by balloons with bailout stenting. For this purpose, BMSs are still preferred over DESs. Thirty percent of BTK lesions are focal proximal lesions (length ≤ 5 cm) and according to this meta-analysis, in such lesions, DESs are safe, significantly reduce TLR compared to BMSs and binary restenosis compared to BMSs, DEBs or PTA, improve primary patency compared to PTAor BMSs with durable results and could potentially reduce major amputations in patients with focal BTK lesions, without any significant impact on mortality and RC.
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DE9 - Unavailable
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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 management of below-the-knee arterial critical ischemia: Update, systematic review and meta-analysis ###Abstract: INTRODUCTION: Percutaneous transluminal angioplasty (PTA), with bailout bare metal stenting (BMS) is currently the treatment of choice in below the knee (BTK) lesions, as drug eluting stents '(DESs) results on limb salvage remain controversial. EVIDENCE ACQUISITION: The present review and meta-analysis was carried out based on a PubMed (Medline), Embase and CENTRALsearch to determine the results of the different strategies available to date in the BTK area and to help select an optimized endovascular approach. EVIDENCE SYNTHESIS: DESs significantly decreased the risk of target lesion revascularization (TLR) compared to BMSs (9.7% vs. 29.0%; OR: 0.26; 95% CI: 0.15-0.46; P<0.00001) and the risk of in-segment binary restenosis compared to PTA(21.9% vs. 41.7%; OR: 0.38; 95%CI: 0.23-0.63; p=0.0002), BMSs (19.9% vs. 50.3%; OR: 0.25; 95%CI: 0.15-0.39; P<0.00001) or DEBs (28% vs. 57.9%; p=0.046). Primary patency was significantly improved compared to PTA (64.9% vs. 49.3%; OR: 0.48; 95% CI: 0.29 to 0.77; P=0.003) or BMSs (85.6% vs. 63.9%; OR: 0.26; 95% CI: 0.14 to 0.49; P<0.0001). There was no significant difference in terms of major amputation rate, Rutherford Class (RC) improvement or mortality. CONCLUSIONS: About 35% of BTK lesions are long lesions (5-20 cm) and are best treated by balloons with bailout stenting. For this purpose, BMSs are still preferred over DESs. Thirty percent of BTK lesions are focal proximal lesions (length ≤ 5 cm) and according to this meta-analysis, in such lesions, DESs are safe, significantly reduce TLR compared to BMSs and binary restenosis compared to BMSs, DEBs or PTA, improve primary patency compared to PTAor BMSs with durable results and could potentially reduce major amputations in patients with focal BTK lesions, without any significant impact on mortality and RC. [/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 management of below-the-knee arterial critical ischemia: Update, systematic review and meta-analysis ###Abstract: INTRODUCTION: Percutaneous transluminal angioplasty (PTA), with bailout bare metal stenting (BMS) is currently the treatment of choice in below the knee (BTK) lesions, as drug eluting stents '(DESs) results on limb salvage remain controversial. EVIDENCE ACQUISITION: The present review and meta-analysis was carried out based on a PubMed (Medline), Embase and CENTRALsearch to determine the results of the different strategies available to date in the BTK area and to help select an optimized endovascular approach. EVIDENCE SYNTHESIS: DESs significantly decreased the risk of target lesion revascularization (TLR) compared to BMSs (9.7% vs. 29.0%; OR: 0.26; 95% CI: 0.15-0.46; P<0.00001) and the risk of in-segment binary restenosis compared to PTA(21.9% vs. 41.7%; OR: 0.38; 95%CI: 0.23-0.63; p=0.0002), BMSs (19.9% vs. 50.3%; OR: 0.25; 95%CI: 0.15-0.39; P<0.00001) or DEBs (28% vs. 57.9%; p=0.046). Primary patency was significantly improved compared to PTA (64.9% vs. 49.3%; OR: 0.48; 95% CI: 0.29 to 0.77; P=0.003) or BMSs (85.6% vs. 63.9%; OR: 0.26; 95% CI: 0.14 to 0.49; P<0.0001). There was no significant difference in terms of major amputation rate, Rutherford Class (RC) improvement or mortality. CONCLUSIONS: About 35% of BTK lesions are long lesions (5-20 cm) and are best treated by balloons with bailout stenting. For this purpose, BMSs are still preferred over DESs. Thirty percent of BTK lesions are focal proximal lesions (length ≤ 5 cm) and according to this meta-analysis, in such lesions, DESs are safe, significantly reduce TLR compared to BMSs and binary restenosis compared to BMSs, DEBs or PTA, improve primary patency compared to PTAor BMSs with durable results and could potentially reduce major amputations in patients with focal BTK lesions, without any significant impact on mortality and RC. [/INST] Exclude </s>
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Cheng 2016
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An update on the clinical use of drug-coated balloons in percutaneous coronary interventions
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ABSTRACT: Introduction: Drug-coated balloons (DCB) promise to deliver anti-proliferative drugs and prevent restenosis leaving nothing behind. Although, randomized clinical trials have demonstrated their efficacy for the treatment of in-stent restenosis, clinical evidence supporting their use in other coronary applications is still lacking. Areas Covered: This review summarizes the development status of clinically available DCB technologies and provides an update on the current data for their coronary use. Expert Opinion: Current generation DCB prevent restenosis by delivering paclitaxel particles on the surface of the vessel wall. Although clinically available technologies share a common mechanism of action, important differences in pharmacokinetic behavior and safety profiles do exist. Future technological improvements include the development of coatings displaying: high transfer efficiency; low particle embolization potential; and alternative drug formulations. Optimized balloon-based delivery systems and drug encapsulation technologies also promise to improve the technical limitations of current generation DCB. Although proving clinical superiority against DES may prove to be difficult in mainstream applications (i.e., de novo), new generation DCB technologies have the potential to achieve a strong position in the interventional field in clinical settings in which the efficacy of DES use is not proven or justified (i.e., bifurcations).
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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: An update on the clinical use of drug-coated balloons in percutaneous coronary interventions ###Abstract: ABSTRACT: Introduction: Drug-coated balloons (DCB) promise to deliver anti-proliferative drugs and prevent restenosis leaving nothing behind. Although, randomized clinical trials have demonstrated their efficacy for the treatment of in-stent restenosis, clinical evidence supporting their use in other coronary applications is still lacking. Areas Covered: This review summarizes the development status of clinically available DCB technologies and provides an update on the current data for their coronary use. Expert Opinion: Current generation DCB prevent restenosis by delivering paclitaxel particles on the surface of the vessel wall. Although clinically available technologies share a common mechanism of action, important differences in pharmacokinetic behavior and safety profiles do exist. Future technological improvements include the development of coatings displaying: high transfer efficiency; low particle embolization potential; and alternative drug formulations. Optimized balloon-based delivery systems and drug encapsulation technologies also promise to improve the technical limitations of current generation DCB. Although proving clinical superiority against DES may prove to be difficult in mainstream applications (i.e., de novo), new generation DCB technologies have the potential to achieve a strong position in the interventional field in clinical settings in which the efficacy of DES use is not proven or justified (i.e., bifurcations). [/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: An update on the clinical use of drug-coated balloons in percutaneous coronary interventions ###Abstract: ABSTRACT: Introduction: Drug-coated balloons (DCB) promise to deliver anti-proliferative drugs and prevent restenosis leaving nothing behind. Although, randomized clinical trials have demonstrated their efficacy for the treatment of in-stent restenosis, clinical evidence supporting their use in other coronary applications is still lacking. Areas Covered: This review summarizes the development status of clinically available DCB technologies and provides an update on the current data for their coronary use. Expert Opinion: Current generation DCB prevent restenosis by delivering paclitaxel particles on the surface of the vessel wall. Although clinically available technologies share a common mechanism of action, important differences in pharmacokinetic behavior and safety profiles do exist. Future technological improvements include the development of coatings displaying: high transfer efficiency; low particle embolization potential; and alternative drug formulations. Optimized balloon-based delivery systems and drug encapsulation technologies also promise to improve the technical limitations of current generation DCB. Although proving clinical superiority against DES may prove to be difficult in mainstream applications (i.e., de novo), new generation DCB technologies have the potential to achieve a strong position in the interventional field in clinical settings in which the efficacy of DES use is not proven or justified (i.e., bifurcations). [/INST] Exclude </s>
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Chi 2019
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Optical coherence tomography evaluation of superficial femoral artery directional atherectomy
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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: Optical coherence tomography evaluation of superficial femoral artery directional atherectomy ###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: Optical coherence tomography evaluation of superficial femoral artery directional atherectomy ###Abstract: None [/INST] Exclude </s>
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Cho 2020
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Directional atherectomy for treating in-stent restenosis of the superficial femoral artery
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Purpose: The optimal treatment for in-stent restenosis (ISR) of the superficial femoral artery (SFA) is still in debate. This study aimed to evaluate the safety and effectiveness of directional atherectomy (DA) as a primary treatment modality for ISR in SFA. Materials and Methods: A retrospective single-center analysis was conducted. In total, 617 stents were deployed in 242 limbs for SFA diseases during the study period. ISR was identified in 29 limbs (12.0%); 14 limbs were treated with DA and 15 limbs with balloon angioplasty (BAP) alone. Technical success rate, target lesion revascularization (TLR) and patency rates (PRs) at 12 months, and any complications were evaluated. Results: DA group included complete occlusions in 50% of patients and BAP group included in 40%. Mean improvement in the ankle-brachial index was 0.29 and 0.32, respectively (P=0.638). Technical success was achieved in all patients. The procedural success rates were 85.7% and 73.3%, respectively (P=0.651). There was no significant difference regarding residual stenosis, distal embolization, or flow-limiting dissection. Primary PRs at 1 year were 85.7% and 73.3%, secondary PRs were 100.0% and 93.3%, and TLR rates were 14.3% and 20.0% (P=0.411, 0.326, and 0.684, respectively). Conclusion: Short-term outcomes after DA for ISR were not different from those after BAP but showed a tendency of better primary PR and TLR. Larger multicenter prospective studies are needed to define the role of DA in ISR treatment.
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DE3 - Wrong Design
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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 for treating in-stent restenosis of the superficial femoral artery ###Abstract: Purpose: The optimal treatment for in-stent restenosis (ISR) of the superficial femoral artery (SFA) is still in debate. This study aimed to evaluate the safety and effectiveness of directional atherectomy (DA) as a primary treatment modality for ISR in SFA. Materials and Methods: A retrospective single-center analysis was conducted. In total, 617 stents were deployed in 242 limbs for SFA diseases during the study period. ISR was identified in 29 limbs (12.0%); 14 limbs were treated with DA and 15 limbs with balloon angioplasty (BAP) alone. Technical success rate, target lesion revascularization (TLR) and patency rates (PRs) at 12 months, and any complications were evaluated. Results: DA group included complete occlusions in 50% of patients and BAP group included in 40%. Mean improvement in the ankle-brachial index was 0.29 and 0.32, respectively (P=0.638). Technical success was achieved in all patients. The procedural success rates were 85.7% and 73.3%, respectively (P=0.651). There was no significant difference regarding residual stenosis, distal embolization, or flow-limiting dissection. Primary PRs at 1 year were 85.7% and 73.3%, secondary PRs were 100.0% and 93.3%, and TLR rates were 14.3% and 20.0% (P=0.411, 0.326, and 0.684, respectively). Conclusion: Short-term outcomes after DA for ISR were not different from those after BAP but showed a tendency of better primary PR and TLR. Larger multicenter prospective studies are needed to define the role of DA in ISR 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: Directional atherectomy for treating in-stent restenosis of the superficial femoral artery ###Abstract: Purpose: The optimal treatment for in-stent restenosis (ISR) of the superficial femoral artery (SFA) is still in debate. This study aimed to evaluate the safety and effectiveness of directional atherectomy (DA) as a primary treatment modality for ISR in SFA. Materials and Methods: A retrospective single-center analysis was conducted. In total, 617 stents were deployed in 242 limbs for SFA diseases during the study period. ISR was identified in 29 limbs (12.0%); 14 limbs were treated with DA and 15 limbs with balloon angioplasty (BAP) alone. Technical success rate, target lesion revascularization (TLR) and patency rates (PRs) at 12 months, and any complications were evaluated. Results: DA group included complete occlusions in 50% of patients and BAP group included in 40%. Mean improvement in the ankle-brachial index was 0.29 and 0.32, respectively (P=0.638). Technical success was achieved in all patients. The procedural success rates were 85.7% and 73.3%, respectively (P=0.651). There was no significant difference regarding residual stenosis, distal embolization, or flow-limiting dissection. Primary PRs at 1 year were 85.7% and 73.3%, secondary PRs were 100.0% and 93.3%, and TLR rates were 14.3% and 20.0% (P=0.411, 0.326, and 0.684, respectively). Conclusion: Short-term outcomes after DA for ISR were not different from those after BAP but showed a tendency of better primary PR and TLR. Larger multicenter prospective studies are needed to define the role of DA in ISR treatment. [/INST] Exclude </s>
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Cohen 2016
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Emergency revascularization of acute internal carotid artery occlusion: Follow the spike, it guides you
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The present study sought to examine the incidence of the angiographic "spike sign" and to assess its predictive significance for achieving carotid revascularization in 54 patients with acute internal carotid artery (ICA) occlusions that required urgent endovascular revascularization. Clinical and imaging files of consecutive patients with ICA occlusion who were treated in a tertiary care academic medical center from 2011-2015 were retrospectively examined under Institutional Review Board approval with a waiver of the requirement for informed consent. All proximal ICA occlusions were treated by stent-assisted carotid angioplasty, and all distal embolic occlusions were managed with stent-assisted mechanical thrombectomy. The study included 24 patients with acute ICA occlusion (group 1) and 30 patients with tandem ICA-intracranial occlusions (group 2). The spike sign was seen in 16/24 patients in group 1 (67%), and successful ICA revascularization was achieved in 14/16 (88%). The sign was seen in 26/30 patients in group 2 (87%), and ICA revascularization was successful in all 26 (100%). The remaining 12 patients had no spike sign, and ICA revascularization was successful in only 7/12 (58%). The spike sign is a transient finding that represents the proximal patent remnant of the stenotic corridor in fresh clot. Acute ICA occlusion frequently leaves the spike sign as a marker of the recent thrombotic event. The spike vertex points to the "path of least resistance" for the guidewire to cross the occlusion and engage the true arterial lumen, a critical step during ICA endovascular revascularization.
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DE7 - Device not mentioned
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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: Emergency revascularization of acute internal carotid artery occlusion: Follow the spike, it guides you ###Abstract: The present study sought to examine the incidence of the angiographic "spike sign" and to assess its predictive significance for achieving carotid revascularization in 54 patients with acute internal carotid artery (ICA) occlusions that required urgent endovascular revascularization. Clinical and imaging files of consecutive patients with ICA occlusion who were treated in a tertiary care academic medical center from 2011-2015 were retrospectively examined under Institutional Review Board approval with a waiver of the requirement for informed consent. All proximal ICA occlusions were treated by stent-assisted carotid angioplasty, and all distal embolic occlusions were managed with stent-assisted mechanical thrombectomy. The study included 24 patients with acute ICA occlusion (group 1) and 30 patients with tandem ICA-intracranial occlusions (group 2). The spike sign was seen in 16/24 patients in group 1 (67%), and successful ICA revascularization was achieved in 14/16 (88%). The sign was seen in 26/30 patients in group 2 (87%), and ICA revascularization was successful in all 26 (100%). The remaining 12 patients had no spike sign, and ICA revascularization was successful in only 7/12 (58%). The spike sign is a transient finding that represents the proximal patent remnant of the stenotic corridor in fresh clot. Acute ICA occlusion frequently leaves the spike sign as a marker of the recent thrombotic event. The spike vertex points to the "path of least resistance" for the guidewire to cross the occlusion and engage the true arterial lumen, a critical step during ICA endovascular 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: Emergency revascularization of acute internal carotid artery occlusion: Follow the spike, it guides you ###Abstract: The present study sought to examine the incidence of the angiographic "spike sign" and to assess its predictive significance for achieving carotid revascularization in 54 patients with acute internal carotid artery (ICA) occlusions that required urgent endovascular revascularization. Clinical and imaging files of consecutive patients with ICA occlusion who were treated in a tertiary care academic medical center from 2011-2015 were retrospectively examined under Institutional Review Board approval with a waiver of the requirement for informed consent. All proximal ICA occlusions were treated by stent-assisted carotid angioplasty, and all distal embolic occlusions were managed with stent-assisted mechanical thrombectomy. The study included 24 patients with acute ICA occlusion (group 1) and 30 patients with tandem ICA-intracranial occlusions (group 2). The spike sign was seen in 16/24 patients in group 1 (67%), and successful ICA revascularization was achieved in 14/16 (88%). The sign was seen in 26/30 patients in group 2 (87%), and ICA revascularization was successful in all 26 (100%). The remaining 12 patients had no spike sign, and ICA revascularization was successful in only 7/12 (58%). The spike sign is a transient finding that represents the proximal patent remnant of the stenotic corridor in fresh clot. Acute ICA occlusion frequently leaves the spike sign as a marker of the recent thrombotic event. The spike vertex points to the "path of least resistance" for the guidewire to cross the occlusion and engage the true arterial lumen, a critical step during ICA endovascular revascularization. [/INST] Exclude </s>
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Colleran 2016
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Drug coated balloon angioplasty in the treatment of peripheral artery disease
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Introduction: Conventional therapies for transcatheter treatment of patients with obstructive peripheral artery disease of the lower limb remain compromised by high restenosis rates. Drug-coated balloons (DCB) offer a novel therapeutic alternative for such patients, providing local delivery of antirestenotic drug to the vessel wall, targeting the source of neo-intimal hyperplasia, without the need for a permanent endovascular mechanical scaffold and their inherent limitations. Areas covered: In this article, we present an up-to-date review of the clinical trial literature relating to DCB therapy of infrainguinal obstructive peripheral artery disease as well as a summary of ongoing trials and future directions. Expert commentary: At present, convincing data exists to support the use of DCB in femoropopliteal disease but the role of DCB in the treatment of tibialpedal disease remains less well defined. More randomized data are needed to clarify this, including comparative effectiveness studies against treatment modalities other than PTA, as well as evaluation of their role in combination with adjunctive therapies.
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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: Drug coated balloon angioplasty in the treatment of peripheral artery disease ###Abstract: Introduction: Conventional therapies for transcatheter treatment of patients with obstructive peripheral artery disease of the lower limb remain compromised by high restenosis rates. Drug-coated balloons (DCB) offer a novel therapeutic alternative for such patients, providing local delivery of antirestenotic drug to the vessel wall, targeting the source of neo-intimal hyperplasia, without the need for a permanent endovascular mechanical scaffold and their inherent limitations. Areas covered: In this article, we present an up-to-date review of the clinical trial literature relating to DCB therapy of infrainguinal obstructive peripheral artery disease as well as a summary of ongoing trials and future directions. Expert commentary: At present, convincing data exists to support the use of DCB in femoropopliteal disease but the role of DCB in the treatment of tibialpedal disease remains less well defined. More randomized data are needed to clarify this, including comparative effectiveness studies against treatment modalities other than PTA, as well as evaluation of their role in combination with adjunctive 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 angioplasty in the treatment of peripheral artery disease ###Abstract: Introduction: Conventional therapies for transcatheter treatment of patients with obstructive peripheral artery disease of the lower limb remain compromised by high restenosis rates. Drug-coated balloons (DCB) offer a novel therapeutic alternative for such patients, providing local delivery of antirestenotic drug to the vessel wall, targeting the source of neo-intimal hyperplasia, without the need for a permanent endovascular mechanical scaffold and their inherent limitations. Areas covered: In this article, we present an up-to-date review of the clinical trial literature relating to DCB therapy of infrainguinal obstructive peripheral artery disease as well as a summary of ongoing trials and future directions. Expert commentary: At present, convincing data exists to support the use of DCB in femoropopliteal disease but the role of DCB in the treatment of tibialpedal disease remains less well defined. More randomized data are needed to clarify this, including comparative effectiveness studies against treatment modalities other than PTA, as well as evaluation of their role in combination with adjunctive therapies. [/INST] Exclude </s>
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Corballis 2020
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Duration of dual antiplatelet therapy in elective drug-coated balloon angioplasty
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Objectives: We sought to answer whether 1-month duration of dual antiplatelet therapy (DAPT) is safe after elective drug-coated balloon only (DCB) angioplasty. Background: The duration of DAPT after elective DCB was called into question after the ESC Focused DAPT Update of 2017. Until then, a 1-month duration of DAPT was considered safe by national consensus groups (German, Italian, and Chinese) supported by data from prospective worldwide registries. The ESC Guidelines recommended a 6-month duration of DAPT based on evidence from in-stent restenosis randomized controlled trials only. Methods: Retrospective, real-world population, single-center analysis conducted from January 1, 2012 to March 31, 2017 in a high-volume, tertiary PCI center. Consecutive patients receiving 1-month duration of DAPT after elective DCB angioplasty were included. We identified a primary composite outcome of cardiac death, myocardial infarction and target lesion revascularization at 6-months. Results: A total of 303 patients (78.5% male) with mean age of 67 ± 12.5 were included. This incorporated 86.1% de novo lesions and 56.5% nonsmall (≥3 mm diameter) coronary arteries treated. There were no reported outcomes of lesion thrombosis, target vessel MI, target lesion revascularization or cardiac death at 6-months. There were two (0.6%) nontarget vessel MIs and one (0.3%) noncardiac death. Conclusion: One-month duration of DAPT appears safe after elective DCB-only angioplasty, highlighting this strategy for patients at high-risk of bleeding. These results also show favorable clinical outcomes for de novo coronary artery disease and nonsmall coronary arteries treated with DCB-only angioplasty. A 1-month duration of DAPT appears a safe and attractive option.
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DE3 - Wrong Design
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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: Duration of dual antiplatelet therapy in elective drug-coated balloon angioplasty ###Abstract: Objectives: We sought to answer whether 1-month duration of dual antiplatelet therapy (DAPT) is safe after elective drug-coated balloon only (DCB) angioplasty. Background: The duration of DAPT after elective DCB was called into question after the ESC Focused DAPT Update of 2017. Until then, a 1-month duration of DAPT was considered safe by national consensus groups (German, Italian, and Chinese) supported by data from prospective worldwide registries. The ESC Guidelines recommended a 6-month duration of DAPT based on evidence from in-stent restenosis randomized controlled trials only. Methods: Retrospective, real-world population, single-center analysis conducted from January 1, 2012 to March 31, 2017 in a high-volume, tertiary PCI center. Consecutive patients receiving 1-month duration of DAPT after elective DCB angioplasty were included. We identified a primary composite outcome of cardiac death, myocardial infarction and target lesion revascularization at 6-months. Results: A total of 303 patients (78.5% male) with mean age of 67 ± 12.5 were included. This incorporated 86.1% de novo lesions and 56.5% nonsmall (≥3 mm diameter) coronary arteries treated. There were no reported outcomes of lesion thrombosis, target vessel MI, target lesion revascularization or cardiac death at 6-months. There were two (0.6%) nontarget vessel MIs and one (0.3%) noncardiac death. Conclusion: One-month duration of DAPT appears safe after elective DCB-only angioplasty, highlighting this strategy for patients at high-risk of bleeding. These results also show favorable clinical outcomes for de novo coronary artery disease and nonsmall coronary arteries treated with DCB-only angioplasty. A 1-month duration of DAPT appears a safe and attractive option. [/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: Duration of dual antiplatelet therapy in elective drug-coated balloon angioplasty ###Abstract: Objectives: We sought to answer whether 1-month duration of dual antiplatelet therapy (DAPT) is safe after elective drug-coated balloon only (DCB) angioplasty. Background: The duration of DAPT after elective DCB was called into question after the ESC Focused DAPT Update of 2017. Until then, a 1-month duration of DAPT was considered safe by national consensus groups (German, Italian, and Chinese) supported by data from prospective worldwide registries. The ESC Guidelines recommended a 6-month duration of DAPT based on evidence from in-stent restenosis randomized controlled trials only. Methods: Retrospective, real-world population, single-center analysis conducted from January 1, 2012 to March 31, 2017 in a high-volume, tertiary PCI center. Consecutive patients receiving 1-month duration of DAPT after elective DCB angioplasty were included. We identified a primary composite outcome of cardiac death, myocardial infarction and target lesion revascularization at 6-months. Results: A total of 303 patients (78.5% male) with mean age of 67 ± 12.5 were included. This incorporated 86.1% de novo lesions and 56.5% nonsmall (≥3 mm diameter) coronary arteries treated. There were no reported outcomes of lesion thrombosis, target vessel MI, target lesion revascularization or cardiac death at 6-months. There were two (0.6%) nontarget vessel MIs and one (0.3%) noncardiac death. Conclusion: One-month duration of DAPT appears safe after elective DCB-only angioplasty, highlighting this strategy for patients at high-risk of bleeding. These results also show favorable clinical outcomes for de novo coronary artery disease and nonsmall coronary arteries treated with DCB-only angioplasty. A 1-month duration of DAPT appears a safe and attractive option. [/INST] Exclude </s>
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Dan 2020
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Paclitaxel-related balloons and stents for the treatment of peripheral artery disease: Insights from the Food and Drug Administration 2019 Circulatory System Devices Panel Meeting on late mortality: Paclitaxel devices in PAD treatment
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Following the December 2018 publication of a meta-analysis by Katsanos et al reporting higher rates of long-term mortality with the utilization of paclitaxel-related devices (balloons and stents) when compared to control in femoropopliteal arteries, the US Food and Drug Administration (FDA) issued a safety alert in January 2019 and further detailed the implications for future clinical use of these devices in March 2019. The FDA convened a public meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee in June 2019. This report summarizes the proceedings of this meeting and the panel's response to the 12 questions posed by the FDA related to the potentially increased late mortality of drug-coated balloons and drug-eluting stents with paclitaxel in patients with peripheral arterial disease.
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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: Paclitaxel-related balloons and stents for the treatment of peripheral artery disease: Insights from the Food and Drug Administration 2019 Circulatory System Devices Panel Meeting on late mortality: Paclitaxel devices in PAD treatment ###Abstract: Following the December 2018 publication of a meta-analysis by Katsanos et al reporting higher rates of long-term mortality with the utilization of paclitaxel-related devices (balloons and stents) when compared to control in femoropopliteal arteries, the US Food and Drug Administration (FDA) issued a safety alert in January 2019 and further detailed the implications for future clinical use of these devices in March 2019. The FDA convened a public meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee in June 2019. This report summarizes the proceedings of this meeting and the panel's response to the 12 questions posed by the FDA related to the potentially increased late mortality of drug-coated balloons and drug-eluting stents with paclitaxel in patients with peripheral arterial 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: Paclitaxel-related balloons and stents for the treatment of peripheral artery disease: Insights from the Food and Drug Administration 2019 Circulatory System Devices Panel Meeting on late mortality: Paclitaxel devices in PAD treatment ###Abstract: Following the December 2018 publication of a meta-analysis by Katsanos et al reporting higher rates of long-term mortality with the utilization of paclitaxel-related devices (balloons and stents) when compared to control in femoropopliteal arteries, the US Food and Drug Administration (FDA) issued a safety alert in January 2019 and further detailed the implications for future clinical use of these devices in March 2019. The FDA convened a public meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee in June 2019. This report summarizes the proceedings of this meeting and the panel's response to the 12 questions posed by the FDA related to the potentially increased late mortality of drug-coated balloons and drug-eluting stents with paclitaxel in patients with peripheral arterial disease. [/INST] Exclude </s>
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Dessi 2018
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Debulking plus drug-coated balloon combination as revascularization strategy for complex femoropopliteal lesions
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This paper will discuss the results from the most recent randomized trials and large registries for DCB's and atherectomy, and the drawbacks of these two therapeutic options. It will also discuss the results of combination therapy in complex femoropopliteal lesions. Several studies indicate that combining atherectomy and DCB yields better outcomes in complex calcified lesions, but the only randomized pilot study could not demonstrate a benefit of combination therapy in the mid-term follow-up. Larger, randomized studies are needed to define the role of atherectomy followed by DCB angioplasty further.
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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: Debulking plus drug-coated balloon combination as revascularization strategy for complex femoropopliteal lesions ###Abstract: This paper will discuss the results from the most recent randomized trials and large registries for DCB's and atherectomy, and the drawbacks of these two therapeutic options. It will also discuss the results of combination therapy in complex femoropopliteal lesions. Several studies indicate that combining atherectomy and DCB yields better outcomes in complex calcified lesions, but the only randomized pilot study could not demonstrate a benefit of combination therapy in the mid-term follow-up. Larger, randomized studies are needed to define the role of atherectomy followed by DCB angioplasty further. [/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: Debulking plus drug-coated balloon combination as revascularization strategy for complex femoropopliteal lesions ###Abstract: This paper will discuss the results from the most recent randomized trials and large registries for DCB's and atherectomy, and the drawbacks of these two therapeutic options. It will also discuss the results of combination therapy in complex femoropopliteal lesions. Several studies indicate that combining atherectomy and DCB yields better outcomes in complex calcified lesions, but the only randomized pilot study could not demonstrate a benefit of combination therapy in the mid-term follow-up. Larger, randomized studies are needed to define the role of atherectomy followed by DCB angioplasty further. [/INST] Exclude </s>
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Dobrocky 2019due
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Stent-Retriever Thrombectomy and Rescue Treatment of M1 Occlusions Due to Underlying Intracranial Atherosclerotic Stenosis: Cohort Analysis and Review of the Literature
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Background and Purpose: Data on the management of large vessel occlusion in patients with anterior circulation acute ischemic stroke (AIS) due to underlying intracranial stenosis are scarce. The aim of this retrospective study was to compare endovascular treatment and outcome in AIS patients with and without underlying stenosis of the M1 segment. Materials and Methods: A total of 533 acute stroke patients with an isolated M1 occlusion who underwent mechanical thrombectomy between 02/2010 and 08/2017 were included. Underlying intracranial atherosclerotic stenosis (ICAS) was present in 10 patients (1.9%), whereas 523 patients (98.1%) had an embolic occlusion without stenosis. Results: There was no difference in age, admission National Institutes of Health Stroke Scale, risk factors, Alberta stroke program early CT score or collaterals between the groups. Procedure time (155 vs 40 min, P = 0.001) was significantly longer in the ICAS group where rescue stent-angioplasty was performed in all patients. There was no statistical difference in final modified thrombolysis in cerebral infarction score between both groups (70 vs 88%, P = 0.115). Favorable outcome (modified Rankin Scale ≤ 2) at 90 days was less frequent in patients with ICAS than in the embolic group (0 vs 49.4%, P = 0.004). The mortality rate tended to be higher in the ICAS group (44.4 vs 19.4%, P = 0.082). Conclusion: In patients with AIS, rescue therapy with stent placement to treat underlying ICAS of the M1 segment is technically feasible; however, in our study, a significantly lower rate of favorable outcome was observed in these patients compared to those with thromboembolic M1 occlusions. Level of Evidence: Level 3, non-randomized controlled study.
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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: Stent-Retriever Thrombectomy and Rescue Treatment of M1 Occlusions Due to Underlying Intracranial Atherosclerotic Stenosis: Cohort Analysis and Review of the Literature ###Abstract: Background and Purpose: Data on the management of large vessel occlusion in patients with anterior circulation acute ischemic stroke (AIS) due to underlying intracranial stenosis are scarce. The aim of this retrospective study was to compare endovascular treatment and outcome in AIS patients with and without underlying stenosis of the M1 segment. Materials and Methods: A total of 533 acute stroke patients with an isolated M1 occlusion who underwent mechanical thrombectomy between 02/2010 and 08/2017 were included. Underlying intracranial atherosclerotic stenosis (ICAS) was present in 10 patients (1.9%), whereas 523 patients (98.1%) had an embolic occlusion without stenosis. Results: There was no difference in age, admission National Institutes of Health Stroke Scale, risk factors, Alberta stroke program early CT score or collaterals between the groups. Procedure time (155 vs 40 min, P = 0.001) was significantly longer in the ICAS group where rescue stent-angioplasty was performed in all patients. There was no statistical difference in final modified thrombolysis in cerebral infarction score between both groups (70 vs 88%, P = 0.115). Favorable outcome (modified Rankin Scale ≤ 2) at 90 days was less frequent in patients with ICAS than in the embolic group (0 vs 49.4%, P = 0.004). The mortality rate tended to be higher in the ICAS group (44.4 vs 19.4%, P = 0.082). Conclusion: In patients with AIS, rescue therapy with stent placement to treat underlying ICAS of the M1 segment is technically feasible; however, in our study, a significantly lower rate of favorable outcome was observed in these patients compared to those with thromboembolic M1 occlusions. Level of Evidence: Level 3, non-randomized controlled study. [/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: Stent-Retriever Thrombectomy and Rescue Treatment of M1 Occlusions Due to Underlying Intracranial Atherosclerotic Stenosis: Cohort Analysis and Review of the Literature ###Abstract: Background and Purpose: Data on the management of large vessel occlusion in patients with anterior circulation acute ischemic stroke (AIS) due to underlying intracranial stenosis are scarce. The aim of this retrospective study was to compare endovascular treatment and outcome in AIS patients with and without underlying stenosis of the M1 segment. Materials and Methods: A total of 533 acute stroke patients with an isolated M1 occlusion who underwent mechanical thrombectomy between 02/2010 and 08/2017 were included. Underlying intracranial atherosclerotic stenosis (ICAS) was present in 10 patients (1.9%), whereas 523 patients (98.1%) had an embolic occlusion without stenosis. Results: There was no difference in age, admission National Institutes of Health Stroke Scale, risk factors, Alberta stroke program early CT score or collaterals between the groups. Procedure time (155 vs 40 min, P = 0.001) was significantly longer in the ICAS group where rescue stent-angioplasty was performed in all patients. There was no statistical difference in final modified thrombolysis in cerebral infarction score between both groups (70 vs 88%, P = 0.115). Favorable outcome (modified Rankin Scale ≤ 2) at 90 days was less frequent in patients with ICAS than in the embolic group (0 vs 49.4%, P = 0.004). The mortality rate tended to be higher in the ICAS group (44.4 vs 19.4%, P = 0.082). Conclusion: In patients with AIS, rescue therapy with stent placement to treat underlying ICAS of the M1 segment is technically feasible; however, in our study, a significantly lower rate of favorable outcome was observed in these patients compared to those with thromboembolic M1 occlusions. Level of Evidence: Level 3, non-randomized controlled study. [/INST] Exclude </s>
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Elmariah 2019
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Design and rationale of a randomized noninferiority trial to evaluate the SurVeil drug-coated balloon in subjects with stenotic lesions of the femoropopliteal artery — the TRANSCEND study
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Background: Drug-coated balloons (DCBs), developed to reduce restenosis after percutaneous intervention in peripheral arterial disease (PAD), have been shown to be safe and efficacious, particularly in treating PAD affecting the femoropopliteal segment. The SurVeil DCB uses an excipient intended to optimize both the uniformity and transfer of paclitaxel to the vessel wall, allowing for efficient drug loading and lower systemic exposure than currently available DCBs, Heretofore, clinical outcomes have not previously been compared to other DCBs. Study Design and Objectives: This prospective, multicenter, international, randomized, single-blind, trial will compare 1:1 the SurVeil DCB with the IN.PACT Admiral DCB for treatment of patients with Rutherford classification 2 to 4 due to femoral and/or popliteal arterial disease. The trial will randomize 446 subjects (with reference vessel diameter 4–7 mm and total lesion length ≤180 mm). Subjects will be followed for 60 months. The primary efficacy endpoint is 1 year primary patency, defined as composite freedom from clinically-driven target-lesion revascularization (TLR) and binary restenosis (core lab-adjudicated duplex ultrasound peak systolic velocity ratio ≥2.4, or ≥50% stenosis via angiography). The primary safety endpoint is composite freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically-driven target vessel revascularization through 12 months. The primary analysis is a test of noninferiority of the SurVeil vs. IN.PACT Admiral on the primary efficacy and safety endpoints according to absolute deltas of 15.0% and 10.0%, respectively. Conclusion: The Randomized And Controlled Noninferiority Trial to Evaluate Safety and Clinical Efficacy of the SurVeil DCB in the Treatment of Subjects with Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral (TRANSCEND) study will assess safety and efficacy of the SurVeil DCB relative to a commonly used DCB.
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Exclude
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DE4 - Protocol
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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: Design and rationale of a randomized noninferiority trial to evaluate the SurVeil drug-coated balloon in subjects with stenotic lesions of the femoropopliteal artery — the TRANSCEND study ###Abstract: Background: Drug-coated balloons (DCBs), developed to reduce restenosis after percutaneous intervention in peripheral arterial disease (PAD), have been shown to be safe and efficacious, particularly in treating PAD affecting the femoropopliteal segment. The SurVeil DCB uses an excipient intended to optimize both the uniformity and transfer of paclitaxel to the vessel wall, allowing for efficient drug loading and lower systemic exposure than currently available DCBs, Heretofore, clinical outcomes have not previously been compared to other DCBs. Study Design and Objectives: This prospective, multicenter, international, randomized, single-blind, trial will compare 1:1 the SurVeil DCB with the IN.PACT Admiral DCB for treatment of patients with Rutherford classification 2 to 4 due to femoral and/or popliteal arterial disease. The trial will randomize 446 subjects (with reference vessel diameter 4–7 mm and total lesion length ≤180 mm). Subjects will be followed for 60 months. The primary efficacy endpoint is 1 year primary patency, defined as composite freedom from clinically-driven target-lesion revascularization (TLR) and binary restenosis (core lab-adjudicated duplex ultrasound peak systolic velocity ratio ≥2.4, or ≥50% stenosis via angiography). The primary safety endpoint is composite freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically-driven target vessel revascularization through 12 months. The primary analysis is a test of noninferiority of the SurVeil vs. IN.PACT Admiral on the primary efficacy and safety endpoints according to absolute deltas of 15.0% and 10.0%, respectively. Conclusion: The Randomized And Controlled Noninferiority Trial to Evaluate Safety and Clinical Efficacy of the SurVeil DCB in the Treatment of Subjects with Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral (TRANSCEND) study will assess safety and efficacy of the SurVeil DCB relative to a commonly used 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: Design and rationale of a randomized noninferiority trial to evaluate the SurVeil drug-coated balloon in subjects with stenotic lesions of the femoropopliteal artery — the TRANSCEND study ###Abstract: Background: Drug-coated balloons (DCBs), developed to reduce restenosis after percutaneous intervention in peripheral arterial disease (PAD), have been shown to be safe and efficacious, particularly in treating PAD affecting the femoropopliteal segment. The SurVeil DCB uses an excipient intended to optimize both the uniformity and transfer of paclitaxel to the vessel wall, allowing for efficient drug loading and lower systemic exposure than currently available DCBs, Heretofore, clinical outcomes have not previously been compared to other DCBs. Study Design and Objectives: This prospective, multicenter, international, randomized, single-blind, trial will compare 1:1 the SurVeil DCB with the IN.PACT Admiral DCB for treatment of patients with Rutherford classification 2 to 4 due to femoral and/or popliteal arterial disease. The trial will randomize 446 subjects (with reference vessel diameter 4–7 mm and total lesion length ≤180 mm). Subjects will be followed for 60 months. The primary efficacy endpoint is 1 year primary patency, defined as composite freedom from clinically-driven target-lesion revascularization (TLR) and binary restenosis (core lab-adjudicated duplex ultrasound peak systolic velocity ratio ≥2.4, or ≥50% stenosis via angiography). The primary safety endpoint is composite freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically-driven target vessel revascularization through 12 months. The primary analysis is a test of noninferiority of the SurVeil vs. IN.PACT Admiral on the primary efficacy and safety endpoints according to absolute deltas of 15.0% and 10.0%, respectively. Conclusion: The Randomized And Controlled Noninferiority Trial to Evaluate Safety and Clinical Efficacy of the SurVeil DCB in the Treatment of Subjects with Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral (TRANSCEND) study will assess safety and efficacy of the SurVeil DCB relative to a commonly used DCB. [/INST] Exclude </s>
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Elwany 2018
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Long-term efficacy of drug-coated balloon for renal artery in-stent restenosis
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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: Long-term efficacy of drug-coated balloon for renal artery in-stent restenosis ###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: Long-term efficacy of drug-coated balloon for renal artery in-stent restenosis ###Abstract: None [/INST] Exclude </s>
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Falkowski 2020
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Assessment of mortality and factors affecting outcome of use of paclitaxel-coated stents and bare metal stents in femoropopliteal pad
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The use of drug-coated devices in intravascular therapy is aimed at preventing neointimal hyperplasia caused by excessive proliferation of vascular smooth muscle and thereby restenosis. Although its use seemed initially promising, a recent publication has shown an increased risk of mortality with paclitaxel-coated devices, and there is an urgent need to reaffirm assessments of drug-eluting stents (DES). Objective: The aim of the study was to compare mortality and effectiveness of paclitaxel-coated stents and bare-metal stents (BMS) in the treatment of peripheral arterial disease (PAD) with long-term follow-up. Materials and methods: In a single center randomized study, 256 patients with PAD were treated intravascularly with stent implantation. Patients were randomized into two groups: the first (n = 126) were treated with DES, and the second (n = 130) were treated with BMS. The study included evaluation after the procedure, after about 6 months and 36 months. Co-morbidities, with risks for atherosclerosis, were analyzed in all patients. Patients were evaluated for clinical outcome, restenosis frequency, and safety (complications and total mortality). Results: Clinical benefit at the end of the investigation was statistically significantly better in the DES group compared with the BMS group: 85.7% versus 66.2% (p = 0.0003), respectively. Restenosis occurred significantly less frequently in patients with DES: 16.0% versus BMS: 35.0%, p = 0.012. There was no significant effect of comorbidities on the frequency of restenoses. There were no differences in all-cause mortality over the three years with paclitaxel and no-paclitaxel stents cohorts (8.7% versus 7.1%; long-rank p = 0.575). No association was found with mortality and treatment with DES or BMS. Conclusions: The use of paclitaxel-coated stents gave good clinical benefit and caused a significantly lower frequency of restenosis compared to bare-metal stents. The use of paclitaxel-coated stents did not increase mortality.
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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: Assessment of mortality and factors affecting outcome of use of paclitaxel-coated stents and bare metal stents in femoropopliteal pad ###Abstract: The use of drug-coated devices in intravascular therapy is aimed at preventing neointimal hyperplasia caused by excessive proliferation of vascular smooth muscle and thereby restenosis. Although its use seemed initially promising, a recent publication has shown an increased risk of mortality with paclitaxel-coated devices, and there is an urgent need to reaffirm assessments of drug-eluting stents (DES). Objective: The aim of the study was to compare mortality and effectiveness of paclitaxel-coated stents and bare-metal stents (BMS) in the treatment of peripheral arterial disease (PAD) with long-term follow-up. Materials and methods: In a single center randomized study, 256 patients with PAD were treated intravascularly with stent implantation. Patients were randomized into two groups: the first (n = 126) were treated with DES, and the second (n = 130) were treated with BMS. The study included evaluation after the procedure, after about 6 months and 36 months. Co-morbidities, with risks for atherosclerosis, were analyzed in all patients. Patients were evaluated for clinical outcome, restenosis frequency, and safety (complications and total mortality). Results: Clinical benefit at the end of the investigation was statistically significantly better in the DES group compared with the BMS group: 85.7% versus 66.2% (p = 0.0003), respectively. Restenosis occurred significantly less frequently in patients with DES: 16.0% versus BMS: 35.0%, p = 0.012. There was no significant effect of comorbidities on the frequency of restenoses. There were no differences in all-cause mortality over the three years with paclitaxel and no-paclitaxel stents cohorts (8.7% versus 7.1%; long-rank p = 0.575). No association was found with mortality and treatment with DES or BMS. Conclusions: The use of paclitaxel-coated stents gave good clinical benefit and caused a significantly lower frequency of restenosis compared to bare-metal stents. The use of paclitaxel-coated stents did not increase 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: Assessment of mortality and factors affecting outcome of use of paclitaxel-coated stents and bare metal stents in femoropopliteal pad ###Abstract: The use of drug-coated devices in intravascular therapy is aimed at preventing neointimal hyperplasia caused by excessive proliferation of vascular smooth muscle and thereby restenosis. Although its use seemed initially promising, a recent publication has shown an increased risk of mortality with paclitaxel-coated devices, and there is an urgent need to reaffirm assessments of drug-eluting stents (DES). Objective: The aim of the study was to compare mortality and effectiveness of paclitaxel-coated stents and bare-metal stents (BMS) in the treatment of peripheral arterial disease (PAD) with long-term follow-up. Materials and methods: In a single center randomized study, 256 patients with PAD were treated intravascularly with stent implantation. Patients were randomized into two groups: the first (n = 126) were treated with DES, and the second (n = 130) were treated with BMS. The study included evaluation after the procedure, after about 6 months and 36 months. Co-morbidities, with risks for atherosclerosis, were analyzed in all patients. Patients were evaluated for clinical outcome, restenosis frequency, and safety (complications and total mortality). Results: Clinical benefit at the end of the investigation was statistically significantly better in the DES group compared with the BMS group: 85.7% versus 66.2% (p = 0.0003), respectively. Restenosis occurred significantly less frequently in patients with DES: 16.0% versus BMS: 35.0%, p = 0.012. There was no significant effect of comorbidities on the frequency of restenoses. There were no differences in all-cause mortality over the three years with paclitaxel and no-paclitaxel stents cohorts (8.7% versus 7.1%; long-rank p = 0.575). No association was found with mortality and treatment with DES or BMS. Conclusions: The use of paclitaxel-coated stents gave good clinical benefit and caused a significantly lower frequency of restenosis compared to bare-metal stents. The use of paclitaxel-coated stents did not increase mortality. [/INST] Exclude </s>
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Farooq 2016
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Forward and back aspiration during ST-elevation myocardial infarction: A feasibility study
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Aims: The inability to optimise stent expansion fully whilst simultaneously preventing distal embolisation during ST-elevation myocardial infarction (STEMI) remains a clinical conundrum. We aimed to describe a newly devised angiographic strategy of "forward" and "back" aspiration that leads to more complete thrombus removal and prevention of distal embolisation, to allow high-pressure post-dilatation of the implanted stent to be performed. Methods and results: Forward aspiration was conducted with a conventional aspiration thrombectomy catheter, with bail-out aspiration thrombectomy for angiographically persistent thrombus utilising the larger bore 6 Fr (0.056″) guide catheter extension system (GuideLiner® ; Vascular Solutions, Inc., Minneapolis, MN, USA). Back aspiration was undertaken with a deeply intubated GuideLiner or guide catheter with a vacuum induced within, extending to the inflated angioplasty balloon, to allow for proximal embolic protection during balloon deflation during all stages of the PCI procedure, including high-pressure post-dilatation of the stent to the visually estimated reference vessel diameter (RVD). Over a six-month period 30 consecutive cases were undertaken during working hours. Bail-out GuideLiner-assisted aspiration thrombectomy was performed in 9/30 cases because of inadequate thrombus removal with a conventional aspiration thrombectomy catheter. Back aspiration was performed in all cases. In 27/30 cases high-pressure post-dilatation of the stent was performed. The mean maximum post-dilatation balloon size and mean proximal reference vessel diameter did not significantly differ (3.60±0.41 mm vs. 3.65±0.45 mm, p=0.68). In all cases, implantation +/- post-dilatation of the stent to the visually estimated RVD was achievable without any deterioration in TIMI blood flow or myocardial blush grade. Conclusions: The strategy of forward and back aspiration to facilitate stent implantation and high-pressure post-dilatation during STEMI appears to be safe and effective. Randomised controlled trials are required to confirm the safety and efficacy of this newly devised angiographic strategy.
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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: Forward and back aspiration during ST-elevation myocardial infarction: A feasibility study ###Abstract: Aims: The inability to optimise stent expansion fully whilst simultaneously preventing distal embolisation during ST-elevation myocardial infarction (STEMI) remains a clinical conundrum. We aimed to describe a newly devised angiographic strategy of "forward" and "back" aspiration that leads to more complete thrombus removal and prevention of distal embolisation, to allow high-pressure post-dilatation of the implanted stent to be performed. Methods and results: Forward aspiration was conducted with a conventional aspiration thrombectomy catheter, with bail-out aspiration thrombectomy for angiographically persistent thrombus utilising the larger bore 6 Fr (0.056″) guide catheter extension system (GuideLiner® ; Vascular Solutions, Inc., Minneapolis, MN, USA). Back aspiration was undertaken with a deeply intubated GuideLiner or guide catheter with a vacuum induced within, extending to the inflated angioplasty balloon, to allow for proximal embolic protection during balloon deflation during all stages of the PCI procedure, including high-pressure post-dilatation of the stent to the visually estimated reference vessel diameter (RVD). Over a six-month period 30 consecutive cases were undertaken during working hours. Bail-out GuideLiner-assisted aspiration thrombectomy was performed in 9/30 cases because of inadequate thrombus removal with a conventional aspiration thrombectomy catheter. Back aspiration was performed in all cases. In 27/30 cases high-pressure post-dilatation of the stent was performed. The mean maximum post-dilatation balloon size and mean proximal reference vessel diameter did not significantly differ (3.60±0.41 mm vs. 3.65±0.45 mm, p=0.68). In all cases, implantation +/- post-dilatation of the stent to the visually estimated RVD was achievable without any deterioration in TIMI blood flow or myocardial blush grade. Conclusions: The strategy of forward and back aspiration to facilitate stent implantation and high-pressure post-dilatation during STEMI appears to be safe and effective. Randomised controlled trials are required to confirm the safety and efficacy of this newly devised angiographic strategy. [/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: Forward and back aspiration during ST-elevation myocardial infarction: A feasibility study ###Abstract: Aims: The inability to optimise stent expansion fully whilst simultaneously preventing distal embolisation during ST-elevation myocardial infarction (STEMI) remains a clinical conundrum. We aimed to describe a newly devised angiographic strategy of "forward" and "back" aspiration that leads to more complete thrombus removal and prevention of distal embolisation, to allow high-pressure post-dilatation of the implanted stent to be performed. Methods and results: Forward aspiration was conducted with a conventional aspiration thrombectomy catheter, with bail-out aspiration thrombectomy for angiographically persistent thrombus utilising the larger bore 6 Fr (0.056″) guide catheter extension system (GuideLiner® ; Vascular Solutions, Inc., Minneapolis, MN, USA). Back aspiration was undertaken with a deeply intubated GuideLiner or guide catheter with a vacuum induced within, extending to the inflated angioplasty balloon, to allow for proximal embolic protection during balloon deflation during all stages of the PCI procedure, including high-pressure post-dilatation of the stent to the visually estimated reference vessel diameter (RVD). Over a six-month period 30 consecutive cases were undertaken during working hours. Bail-out GuideLiner-assisted aspiration thrombectomy was performed in 9/30 cases because of inadequate thrombus removal with a conventional aspiration thrombectomy catheter. Back aspiration was performed in all cases. In 27/30 cases high-pressure post-dilatation of the stent was performed. The mean maximum post-dilatation balloon size and mean proximal reference vessel diameter did not significantly differ (3.60±0.41 mm vs. 3.65±0.45 mm, p=0.68). In all cases, implantation +/- post-dilatation of the stent to the visually estimated RVD was achievable without any deterioration in TIMI blood flow or myocardial blush grade. Conclusions: The strategy of forward and back aspiration to facilitate stent implantation and high-pressure post-dilatation during STEMI appears to be safe and effective. Randomised controlled trials are required to confirm the safety and efficacy of this newly devised angiographic strategy. [/INST] Exclude </s>
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Feldman 2018
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SCAI consensus guidelines for device selection in femoral-popliteal arterial interventions
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DE8 - Guidance
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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: SCAI consensus guidelines for device selection in femoral-popliteal arterial interventions ###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: SCAI consensus guidelines for device selection in femoral-popliteal arterial interventions ###Abstract: None [/INST] Exclude </s>
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Gad 2019
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Is There a Safety Concern for Drug-Coated Balloons in Peripheral Arterial Disease?
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Purpose of Review: Drug-coated balloons (DEB) and drug-eluting stents (DES) emerged as a tool to aid in lowering the rates of neointimal hyperplasia and target lesion restenosis following endovascular peripheral arterial disease (PAD) interventions. Recent Findings: Although the initial trials comparing these devices with non-drug balloons and stents showed favorable results, more recent data raised concerns regarding the mid to long-term safety of these devices. Summary: In this review, we will discuss the evolution of endovascular therapy for PAD, with highlights regarding the recent debates on the long-term safety of the drug-coated devices for treatment of PAD.
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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: Is There a Safety Concern for Drug-Coated Balloons in Peripheral Arterial Disease? ###Abstract: Purpose of Review: Drug-coated balloons (DEB) and drug-eluting stents (DES) emerged as a tool to aid in lowering the rates of neointimal hyperplasia and target lesion restenosis following endovascular peripheral arterial disease (PAD) interventions. Recent Findings: Although the initial trials comparing these devices with non-drug balloons and stents showed favorable results, more recent data raised concerns regarding the mid to long-term safety of these devices. Summary: In this review, we will discuss the evolution of endovascular therapy for PAD, with highlights regarding the recent debates on the long-term safety of the drug-coated devices for treatment of PAD. [/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: Is There a Safety Concern for Drug-Coated Balloons in Peripheral Arterial Disease? ###Abstract: Purpose of Review: Drug-coated balloons (DEB) and drug-eluting stents (DES) emerged as a tool to aid in lowering the rates of neointimal hyperplasia and target lesion restenosis following endovascular peripheral arterial disease (PAD) interventions. Recent Findings: Although the initial trials comparing these devices with non-drug balloons and stents showed favorable results, more recent data raised concerns regarding the mid to long-term safety of these devices. Summary: In this review, we will discuss the evolution of endovascular therapy for PAD, with highlights regarding the recent debates on the long-term safety of the drug-coated devices for treatment of PAD. [/INST] Exclude </s>
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Gandini 2016
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Local Ultrasound to Enhance Paclitaxel Delivery After Femoral-Popliteal Treatment in Critical Limb Ischemia: The PACUS Trial
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Objectives The aim of this study was to evaluate the safety and efficacy of percutaneous catheter-delivered ultrasound energy to improve local paclitaxel delivery effects in patients with critical limb ischemia (CLI) treated for femoral-popliteal arterial disease. Background Treatment of patients with CLI continues to be the greatest challenge in peripheral artery disease; in particular, treatment of femoral-popliteal chronic total occlusion is characterized by poor primary patency. Methods This single-center, single-blind, randomized trial included 56 patients with CLI randomly assigned to treatment in 2 groups: 28 patients (the control group) were treated with drug-eluting balloons, and 28 patients (the study group) were treated with intravascular ultrasound using the CardioProlific Genesis System followed by local administration of a liquid mixture of iopromide 370 and paclitaxel 1.0 μg/mm(3). In the study group, mean lesion length was 168.8 mm, and 21 patients had calcifications. In the control group, mean lesion length was 164 mm, and 23 patients had calcifications. Results No adverse procedural events were observed; all 56 patients tolerated the procedure well. At 6-month follow-up, no myocardial infarction, deaths, or amputations were observed in either group. In the study group, the rate of restenosis at 6 months was 3.6% (1 of 28), and the rate of target lesion revascularization (TLR) was 0% (0 of 28); at 12 months, the rate of TLR was 3.8% (1 of 26), and the rate of amputation was 0% (0 of 26). In the control group, the rate of restenosis at 6 months was 21.4% (6 of 28), and the rate of TLR was 10.7% (3 of 28); at 12 months, the rate of TLR was 36% (9 of 25), and the rate of amputation was 16% (4 of 25). Conclusions This study demonstrates encouraging results at 6- and 12-month follow-up in patients treated with ultrasound and paclitaxel compared with drug-eluting balloons. Larger multicenter studies are required to validate this approach.
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Exclude
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DE7 - Device not mentioned
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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: Local Ultrasound to Enhance Paclitaxel Delivery After Femoral-Popliteal Treatment in Critical Limb Ischemia: The PACUS Trial ###Abstract: Objectives The aim of this study was to evaluate the safety and efficacy of percutaneous catheter-delivered ultrasound energy to improve local paclitaxel delivery effects in patients with critical limb ischemia (CLI) treated for femoral-popliteal arterial disease. Background Treatment of patients with CLI continues to be the greatest challenge in peripheral artery disease; in particular, treatment of femoral-popliteal chronic total occlusion is characterized by poor primary patency. Methods This single-center, single-blind, randomized trial included 56 patients with CLI randomly assigned to treatment in 2 groups: 28 patients (the control group) were treated with drug-eluting balloons, and 28 patients (the study group) were treated with intravascular ultrasound using the CardioProlific Genesis System followed by local administration of a liquid mixture of iopromide 370 and paclitaxel 1.0 μg/mm(3). In the study group, mean lesion length was 168.8 mm, and 21 patients had calcifications. In the control group, mean lesion length was 164 mm, and 23 patients had calcifications. Results No adverse procedural events were observed; all 56 patients tolerated the procedure well. At 6-month follow-up, no myocardial infarction, deaths, or amputations were observed in either group. In the study group, the rate of restenosis at 6 months was 3.6% (1 of 28), and the rate of target lesion revascularization (TLR) was 0% (0 of 28); at 12 months, the rate of TLR was 3.8% (1 of 26), and the rate of amputation was 0% (0 of 26). In the control group, the rate of restenosis at 6 months was 21.4% (6 of 28), and the rate of TLR was 10.7% (3 of 28); at 12 months, the rate of TLR was 36% (9 of 25), and the rate of amputation was 16% (4 of 25). Conclusions This study demonstrates encouraging results at 6- and 12-month follow-up in patients treated with ultrasound and paclitaxel compared with drug-eluting balloons. Larger multicenter studies are required to validate this approach. [/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: Local Ultrasound to Enhance Paclitaxel Delivery After Femoral-Popliteal Treatment in Critical Limb Ischemia: The PACUS Trial ###Abstract: Objectives The aim of this study was to evaluate the safety and efficacy of percutaneous catheter-delivered ultrasound energy to improve local paclitaxel delivery effects in patients with critical limb ischemia (CLI) treated for femoral-popliteal arterial disease. Background Treatment of patients with CLI continues to be the greatest challenge in peripheral artery disease; in particular, treatment of femoral-popliteal chronic total occlusion is characterized by poor primary patency. Methods This single-center, single-blind, randomized trial included 56 patients with CLI randomly assigned to treatment in 2 groups: 28 patients (the control group) were treated with drug-eluting balloons, and 28 patients (the study group) were treated with intravascular ultrasound using the CardioProlific Genesis System followed by local administration of a liquid mixture of iopromide 370 and paclitaxel 1.0 μg/mm(3). In the study group, mean lesion length was 168.8 mm, and 21 patients had calcifications. In the control group, mean lesion length was 164 mm, and 23 patients had calcifications. Results No adverse procedural events were observed; all 56 patients tolerated the procedure well. At 6-month follow-up, no myocardial infarction, deaths, or amputations were observed in either group. In the study group, the rate of restenosis at 6 months was 3.6% (1 of 28), and the rate of target lesion revascularization (TLR) was 0% (0 of 28); at 12 months, the rate of TLR was 3.8% (1 of 26), and the rate of amputation was 0% (0 of 26). In the control group, the rate of restenosis at 6 months was 21.4% (6 of 28), and the rate of TLR was 10.7% (3 of 28); at 12 months, the rate of TLR was 36% (9 of 25), and the rate of amputation was 16% (4 of 25). Conclusions This study demonstrates encouraging results at 6- and 12-month follow-up in patients treated with ultrasound and paclitaxel compared with drug-eluting balloons. Larger multicenter studies are required to validate this approach. [/INST] Exclude </s>
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Gatto 2018
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Commentary: All That Glitters Is Not Zilver: Promises and Disappointments of Endovascular Devices for Superficial Femoral Artery Disease
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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: Commentary: All That Glitters Is Not Zilver: Promises and Disappointments of Endovascular Devices for Superficial Femoral Artery Disease ###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: Commentary: All That Glitters Is Not Zilver: Promises and Disappointments of Endovascular Devices for Superficial Femoral Artery Disease ###Abstract: None [/INST] Exclude </s>
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Gedela 2020
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Triple-guidewire technique for treating stent underexpansion in severely calcified coronary artery lesions
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Stent underexpansion, a potential complication of percutaneous coronary intervention in severely calcified and stenotic coronary arteries, may result in in-stent thrombosis and restenosis. Different balloon-based and atheroablative techniques have been proposed to reduce the risk of these complications. We describe a simple triple-guidewire technique that we used to treat stent underexpansion in 2 elderly men. (Tex Heart Inst J 2020;47(2):155-9).
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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: Triple-guidewire technique for treating stent underexpansion in severely calcified coronary artery lesions ###Abstract: Stent underexpansion, a potential complication of percutaneous coronary intervention in severely calcified and stenotic coronary arteries, may result in in-stent thrombosis and restenosis. Different balloon-based and atheroablative techniques have been proposed to reduce the risk of these complications. We describe a simple triple-guidewire technique that we used to treat stent underexpansion in 2 elderly men. (Tex Heart Inst J 2020;47(2):155-9). [/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: Triple-guidewire technique for treating stent underexpansion in severely calcified coronary artery lesions ###Abstract: Stent underexpansion, a potential complication of percutaneous coronary intervention in severely calcified and stenotic coronary arteries, may result in in-stent thrombosis and restenosis. Different balloon-based and atheroablative techniques have been proposed to reduce the risk of these complications. We describe a simple triple-guidewire technique that we used to treat stent underexpansion in 2 elderly men. (Tex Heart Inst J 2020;47(2):155-9). [/INST] Exclude </s>
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Geller 2018
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The Food and Drug Administration Approves More Than a Dozen Devices Through the Premarket Approval Application Process
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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: The Food and Drug Administration Approves More Than a Dozen Devices Through the Premarket Approval Application Process ###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: The Food and Drug Administration Approves More Than a Dozen Devices Through the Premarket Approval Application Process ###Abstract: None [/INST] Exclude </s>
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Giannini 2017
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A propensity score matched comparative study between paclitaxel-coated balloon and everolimus-eluting stents for the treatment of small coronary vessels
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Objectives: To compare the long-term clinical outcomes of paclitaxel drug-coated-balloons (DCB) and everolimus-eluting-stents (EES) following the treatment of de novo small vessel coronary artery disease. Background: It is currently unclear whether treatment of de novo small vessel coronary disease with DCB is comparable to second generation drug-eluting stents, which are the current standard of care. Methods: The present study enrolled 90 patients with small vessel coronary disease from the DCB treatment arm of the BELLO (Balloon Elution and Late Loss Optimization) trial and 2,000 patients treated with EES at the San Raffaele Scientific Institute. Propensity score matching was performed to adjust for differences in baseline clinical and angiographic characteristics, yielding a total of 181 patients: 90 patients with 94 lesions receiving DCB and 91 patients with 94 lesions receiving EES. Major adverse cardiac events (MACE) were defined as the composite of cardiac death, recurrent non-fatal myocardial infarction, and target vessel revascularization. Results: After propensity score matching, baseline clinical and angiographic characteristics were similar between the two groups. The cumulative MACE rate at 1-year was 12.2% with DCB and 15.4% with EES (P = 0.538). Patients in the DCB group had similar TLR rates as compared to EES over the same interval (4.4% vs. 5.6%; P = 0.720). There were no cases of definite or probable stent or vessel thrombosis. Conclusions: The use of paclitaxel-DCB appears to be associated with similar clinical outcomes when compared to second-generation-EES in small coronary artery disease. The findings of this study should be confirmed with larger prospective randomized studies with longer follow-up. © 2017 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: A propensity score matched comparative study between paclitaxel-coated balloon and everolimus-eluting stents for the treatment of small coronary vessels ###Abstract: Objectives: To compare the long-term clinical outcomes of paclitaxel drug-coated-balloons (DCB) and everolimus-eluting-stents (EES) following the treatment of de novo small vessel coronary artery disease. Background: It is currently unclear whether treatment of de novo small vessel coronary disease with DCB is comparable to second generation drug-eluting stents, which are the current standard of care. Methods: The present study enrolled 90 patients with small vessel coronary disease from the DCB treatment arm of the BELLO (Balloon Elution and Late Loss Optimization) trial and 2,000 patients treated with EES at the San Raffaele Scientific Institute. Propensity score matching was performed to adjust for differences in baseline clinical and angiographic characteristics, yielding a total of 181 patients: 90 patients with 94 lesions receiving DCB and 91 patients with 94 lesions receiving EES. Major adverse cardiac events (MACE) were defined as the composite of cardiac death, recurrent non-fatal myocardial infarction, and target vessel revascularization. Results: After propensity score matching, baseline clinical and angiographic characteristics were similar between the two groups. The cumulative MACE rate at 1-year was 12.2% with DCB and 15.4% with EES (P = 0.538). Patients in the DCB group had similar TLR rates as compared to EES over the same interval (4.4% vs. 5.6%; P = 0.720). There were no cases of definite or probable stent or vessel thrombosis. Conclusions: The use of paclitaxel-DCB appears to be associated with similar clinical outcomes when compared to second-generation-EES in small coronary artery disease. The findings of this study should be confirmed with larger prospective randomized studies with longer follow-up. © 2017 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: A propensity score matched comparative study between paclitaxel-coated balloon and everolimus-eluting stents for the treatment of small coronary vessels ###Abstract: Objectives: To compare the long-term clinical outcomes of paclitaxel drug-coated-balloons (DCB) and everolimus-eluting-stents (EES) following the treatment of de novo small vessel coronary artery disease. Background: It is currently unclear whether treatment of de novo small vessel coronary disease with DCB is comparable to second generation drug-eluting stents, which are the current standard of care. Methods: The present study enrolled 90 patients with small vessel coronary disease from the DCB treatment arm of the BELLO (Balloon Elution and Late Loss Optimization) trial and 2,000 patients treated with EES at the San Raffaele Scientific Institute. Propensity score matching was performed to adjust for differences in baseline clinical and angiographic characteristics, yielding a total of 181 patients: 90 patients with 94 lesions receiving DCB and 91 patients with 94 lesions receiving EES. Major adverse cardiac events (MACE) were defined as the composite of cardiac death, recurrent non-fatal myocardial infarction, and target vessel revascularization. Results: After propensity score matching, baseline clinical and angiographic characteristics were similar between the two groups. The cumulative MACE rate at 1-year was 12.2% with DCB and 15.4% with EES (P = 0.538). Patients in the DCB group had similar TLR rates as compared to EES over the same interval (4.4% vs. 5.6%; P = 0.720). There were no cases of definite or probable stent or vessel thrombosis. Conclusions: The use of paclitaxel-DCB appears to be associated with similar clinical outcomes when compared to second-generation-EES in small coronary artery disease. The findings of this study should be confirmed with larger prospective randomized studies with longer follow-up. © 2017 Wiley Periodicals, Inc. [/INST] Exclude </s>
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Giannini 2017
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Comparison of paclitaxel drug-eluting balloon and paclitaxel-eluting stent in small coronary vessels in diabetic and nondiabetic patients – results from the BELLO (balloon elution and late loss optimization) trial
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Objectives To evaluate the impact of diabetes on the efficacy of drug-eluting balloon (DEB) as compared to paclitaxel-eluting stent (PES) for the reduction of restenosis in small vessels according to the presence of diabetes in patients enrolled in the BELLO (Balloon Elution and Late Loss Optimization) trial. Background Small vessel disease is common in diabetic patients but currently there are no available data regarding DEB in these patients. Methods In the BELLO trial, 182 patients with lesions in small vessels were randomized 1:1 to receive DEB or PES. In the current sub analysis, patients were stratified according to the presence of diabetes. The diabetic group consisted of 74 patients (DEB = 39, PES = 35) and the nondiabetic group of 108 patients (DEB = 51, PES = 57). Angiographic endpoints examined were in-stent/in-balloon and in-segment late loss and binary restenosis at 6 months. Clinical endpoints were major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 1 year. Results In-stent/in-balloon late loss was significantly less with DEB as compared to PES in both diabetic (0.05 ± 0.41 vs. 0.30 ± 0.51 mm, p = 0.033) and nondiabetic patients (0.10 ± 0.36 vs. 0.29 ± 0.40 mm, p = 0.015). In patients with diabetes, angiographic restenosis and in-segment late loss were significantly lower with DEB as compared to PES (respectively, 6.3% vs. 25.0%; p = 0.039 and −0.013 ± 0.39 vs. 0.25 ± 0.53; p = 0.023), with no differences noted in nondiabetic patients. The cumulative MACE rate at 1 year was similar between DEB and PES in both the diabetic (13.2% vs. 25%, p = 0.194) and nondiabetic groups (11.8% vs. 14.3%, p = 0.699). Conclusions Diabetes does not appear to have a negative impact on the efficacy of DEB in small vessels, which were associated with better angiographic outcomes at 6 months in this complex subgroup. Larger studies are needed to confirm these findings.
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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: Comparison of paclitaxel drug-eluting balloon and paclitaxel-eluting stent in small coronary vessels in diabetic and nondiabetic patients – results from the BELLO (balloon elution and late loss optimization) trial ###Abstract: Objectives To evaluate the impact of diabetes on the efficacy of drug-eluting balloon (DEB) as compared to paclitaxel-eluting stent (PES) for the reduction of restenosis in small vessels according to the presence of diabetes in patients enrolled in the BELLO (Balloon Elution and Late Loss Optimization) trial. Background Small vessel disease is common in diabetic patients but currently there are no available data regarding DEB in these patients. Methods In the BELLO trial, 182 patients with lesions in small vessels were randomized 1:1 to receive DEB or PES. In the current sub analysis, patients were stratified according to the presence of diabetes. The diabetic group consisted of 74 patients (DEB = 39, PES = 35) and the nondiabetic group of 108 patients (DEB = 51, PES = 57). Angiographic endpoints examined were in-stent/in-balloon and in-segment late loss and binary restenosis at 6 months. Clinical endpoints were major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 1 year. Results In-stent/in-balloon late loss was significantly less with DEB as compared to PES in both diabetic (0.05 ± 0.41 vs. 0.30 ± 0.51 mm, p = 0.033) and nondiabetic patients (0.10 ± 0.36 vs. 0.29 ± 0.40 mm, p = 0.015). In patients with diabetes, angiographic restenosis and in-segment late loss were significantly lower with DEB as compared to PES (respectively, 6.3% vs. 25.0%; p = 0.039 and −0.013 ± 0.39 vs. 0.25 ± 0.53; p = 0.023), with no differences noted in nondiabetic patients. The cumulative MACE rate at 1 year was similar between DEB and PES in both the diabetic (13.2% vs. 25%, p = 0.194) and nondiabetic groups (11.8% vs. 14.3%, p = 0.699). Conclusions Diabetes does not appear to have a negative impact on the efficacy of DEB in small vessels, which were associated with better angiographic outcomes at 6 months in this complex subgroup. Larger studies are needed to confirm these findings. [/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: Comparison of paclitaxel drug-eluting balloon and paclitaxel-eluting stent in small coronary vessels in diabetic and nondiabetic patients – results from the BELLO (balloon elution and late loss optimization) trial ###Abstract: Objectives To evaluate the impact of diabetes on the efficacy of drug-eluting balloon (DEB) as compared to paclitaxel-eluting stent (PES) for the reduction of restenosis in small vessels according to the presence of diabetes in patients enrolled in the BELLO (Balloon Elution and Late Loss Optimization) trial. Background Small vessel disease is common in diabetic patients but currently there are no available data regarding DEB in these patients. Methods In the BELLO trial, 182 patients with lesions in small vessels were randomized 1:1 to receive DEB or PES. In the current sub analysis, patients were stratified according to the presence of diabetes. The diabetic group consisted of 74 patients (DEB = 39, PES = 35) and the nondiabetic group of 108 patients (DEB = 51, PES = 57). Angiographic endpoints examined were in-stent/in-balloon and in-segment late loss and binary restenosis at 6 months. Clinical endpoints were major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 1 year. Results In-stent/in-balloon late loss was significantly less with DEB as compared to PES in both diabetic (0.05 ± 0.41 vs. 0.30 ± 0.51 mm, p = 0.033) and nondiabetic patients (0.10 ± 0.36 vs. 0.29 ± 0.40 mm, p = 0.015). In patients with diabetes, angiographic restenosis and in-segment late loss were significantly lower with DEB as compared to PES (respectively, 6.3% vs. 25.0%; p = 0.039 and −0.013 ± 0.39 vs. 0.25 ± 0.53; p = 0.023), with no differences noted in nondiabetic patients. The cumulative MACE rate at 1 year was similar between DEB and PES in both the diabetic (13.2% vs. 25%, p = 0.194) and nondiabetic groups (11.8% vs. 14.3%, p = 0.699). Conclusions Diabetes does not appear to have a negative impact on the efficacy of DEB in small vessels, which were associated with better angiographic outcomes at 6 months in this complex subgroup. Larger studies are needed to confirm these findings. [/INST] Exclude </s>
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Gil 2019
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Five-year clinical outcomes following drug-eluting stent implantation in left main trifurcations
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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: Five-year clinical outcomes following drug-eluting stent implantation in left main trifurcations ###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: Five-year clinical outcomes following drug-eluting stent implantation in left main trifurcations ###Abstract: None [/INST] Exclude </s>
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Hachinohe 2018
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Treatment for in-stent restenosis requiring rotational atherectomy
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Objectives: This study aimed to evaluate the outcomes of patients with in-stent restenosis (ISR) who underwent rotablation (RA) followed by balloon angioplasty (BA), drug-eluting stent (DES) implantation, or drug-coated balloon (DCB) angioplasty. Background: Interventional treatment of ISR is occasionally challenging. Despite the availability of various percutaneous treatments, the optimal solution remains unclear. Methods and Results: A total of 200 patients with ISR who underwent RA were retrospectively identified from our institutional database. Clinical outcomes at 12 months and independent predictors of target lesion revascularization (TLR) were assessed. Of patients, 90, 55, and 55 underwent BA, DES implantation, and DCB angioplasty, respectively. The incidence of all-cause death, cardiac death, and hospitalization due to heart failure was low in all groups. Moreover, no definite stent thrombosis was observed in the three groups. The TLR rate of BA, DES implantation, and DCB angioplasty following RA for ISR were 40.7%, 35.0%, and 27.3%, respectively. The adjusted outcomes for TLR using the inverse probability of treatment weighting method based on propensity scores indicated that DCB angioplasty following RA was superior to BA after RA. Intraprocedural complications, which could be successfully managed with interventional treatment, were identified in only three cases. Conclusions: TLR at 12 months is dismal. RA is not effective for ISR requiring RA. In unfavorable settings, DCB angioplasty following RA is the most effective treatment option in patients with ISR requiring debulking strategy.
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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: Treatment for in-stent restenosis requiring rotational atherectomy ###Abstract: Objectives: This study aimed to evaluate the outcomes of patients with in-stent restenosis (ISR) who underwent rotablation (RA) followed by balloon angioplasty (BA), drug-eluting stent (DES) implantation, or drug-coated balloon (DCB) angioplasty. Background: Interventional treatment of ISR is occasionally challenging. Despite the availability of various percutaneous treatments, the optimal solution remains unclear. Methods and Results: A total of 200 patients with ISR who underwent RA were retrospectively identified from our institutional database. Clinical outcomes at 12 months and independent predictors of target lesion revascularization (TLR) were assessed. Of patients, 90, 55, and 55 underwent BA, DES implantation, and DCB angioplasty, respectively. The incidence of all-cause death, cardiac death, and hospitalization due to heart failure was low in all groups. Moreover, no definite stent thrombosis was observed in the three groups. The TLR rate of BA, DES implantation, and DCB angioplasty following RA for ISR were 40.7%, 35.0%, and 27.3%, respectively. The adjusted outcomes for TLR using the inverse probability of treatment weighting method based on propensity scores indicated that DCB angioplasty following RA was superior to BA after RA. Intraprocedural complications, which could be successfully managed with interventional treatment, were identified in only three cases. Conclusions: TLR at 12 months is dismal. RA is not effective for ISR requiring RA. In unfavorable settings, DCB angioplasty following RA is the most effective treatment option in patients with ISR requiring debulking strategy. [/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 for in-stent restenosis requiring rotational atherectomy ###Abstract: Objectives: This study aimed to evaluate the outcomes of patients with in-stent restenosis (ISR) who underwent rotablation (RA) followed by balloon angioplasty (BA), drug-eluting stent (DES) implantation, or drug-coated balloon (DCB) angioplasty. Background: Interventional treatment of ISR is occasionally challenging. Despite the availability of various percutaneous treatments, the optimal solution remains unclear. Methods and Results: A total of 200 patients with ISR who underwent RA were retrospectively identified from our institutional database. Clinical outcomes at 12 months and independent predictors of target lesion revascularization (TLR) were assessed. Of patients, 90, 55, and 55 underwent BA, DES implantation, and DCB angioplasty, respectively. The incidence of all-cause death, cardiac death, and hospitalization due to heart failure was low in all groups. Moreover, no definite stent thrombosis was observed in the three groups. The TLR rate of BA, DES implantation, and DCB angioplasty following RA for ISR were 40.7%, 35.0%, and 27.3%, respectively. The adjusted outcomes for TLR using the inverse probability of treatment weighting method based on propensity scores indicated that DCB angioplasty following RA was superior to BA after RA. Intraprocedural complications, which could be successfully managed with interventional treatment, were identified in only three cases. Conclusions: TLR at 12 months is dismal. RA is not effective for ISR requiring RA. In unfavorable settings, DCB angioplasty following RA is the most effective treatment option in patients with ISR requiring debulking strategy. [/INST] Exclude </s>
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Haga 2019
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Three cases of fusion imaging in endovascular treatment of occlusive peripheral artery disease
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Endovascular treatment of peripheral artery disease has dramatically improved in the past decades; however, occlusive or stenotic lesions of the femoral-popliteal artery segment remain a significant challenge for vascular specialists. Real-time guidance based on vessel visualization might be helpful for successful recanalization. Herein, we present three successful cases of fusion imaging during endovascular treatment of the femoral-popliteal artery segments.
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DE3 - Wrong Design
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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 cases of fusion imaging in endovascular treatment of occlusive peripheral artery disease ###Abstract: Endovascular treatment of peripheral artery disease has dramatically improved in the past decades; however, occlusive or stenotic lesions of the femoral-popliteal artery segment remain a significant challenge for vascular specialists. Real-time guidance based on vessel visualization might be helpful for successful recanalization. Herein, we present three successful cases of fusion imaging during endovascular treatment of the femoral-popliteal artery segments. [/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 cases of fusion imaging in endovascular treatment of occlusive peripheral artery disease ###Abstract: Endovascular treatment of peripheral artery disease has dramatically improved in the past decades; however, occlusive or stenotic lesions of the femoral-popliteal artery segment remain a significant challenge for vascular specialists. Real-time guidance based on vessel visualization might be helpful for successful recanalization. Herein, we present three successful cases of fusion imaging during endovascular treatment of the femoral-popliteal artery segments. [/INST] Exclude </s>
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Hallak 2018
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Percutaneous axillary access for large-bore arteriotomy: A step-by-step guide
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The last decade has witnessed a tremendous growth in the type and complexity of transcatheter cardiovascular interventions that require large-bore access. While the common femoral artery has become the main route for these interventions, sizable cohorts of patients are unsuitable for transfemoral access due to vascular disease or small vessel caliber. Percutaneous axillary access has emerged as a feasible alternative in these patients. We provide a step-by-step guide for transaxillary large-bore access and closure for patients requiring transcatheter interventions.
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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: Percutaneous axillary access for large-bore arteriotomy: A step-by-step guide ###Abstract: The last decade has witnessed a tremendous growth in the type and complexity of transcatheter cardiovascular interventions that require large-bore access. While the common femoral artery has become the main route for these interventions, sizable cohorts of patients are unsuitable for transfemoral access due to vascular disease or small vessel caliber. Percutaneous axillary access has emerged as a feasible alternative in these patients. We provide a step-by-step guide for transaxillary large-bore access and closure for patients requiring transcatheter interventions. [/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: Percutaneous axillary access for large-bore arteriotomy: A step-by-step guide ###Abstract: The last decade has witnessed a tremendous growth in the type and complexity of transcatheter cardiovascular interventions that require large-bore access. While the common femoral artery has become the main route for these interventions, sizable cohorts of patients are unsuitable for transfemoral access due to vascular disease or small vessel caliber. Percutaneous axillary access has emerged as a feasible alternative in these patients. We provide a step-by-step guide for transaxillary large-bore access and closure for patients requiring transcatheter interventions. [/INST] Exclude </s>
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Hammad 2017
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The Contemporary Role of Stents and Angioplasty for the Treatment of Infrapopliteal Disease in Critical Limb Ischemia
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Purpose of Review: Critical limb ischemia (CLI) is associated with significant morbidity, mortality, and increased health care expenses. Revascularization has a central role in the treatment of CLI. Following publication of BASIL (bypass versus angioplasty in severe ischemia of the leg) trial a decade ago, an “endovascular first” approach had gained momentum and the technologies available for endovascular therapy have exponentially increased. Both the development of technology and technique, highlighted in this review, have allowed operators to treat complex infrapopliteal lesions which are central to CLI pathology. Recent Findings: The role of atherectomy remains controversial but for calcified lesions it has become an accepted adjunctive tool for plaque modification. The place of drug delivery technologies requires further trials. The use of a drug-coated balloon (DCB) makes intuitive sense; however, choice of excipient, lower limit of vessel size, and impact on remodeling and thrombosis remain uncertain. Summary: The optimal treatment of infrapopliteal disease remains an area of active investigation. The endpoints in CLI trials continue to be challenging and calibration of patency in relation to wound healing remains a moving target. In addition, unaccounted variables continue to confound interpretation of CLI trials—including quality and nature of wound care, status of pedal-plantar loop patency, and management of underlying diabetes and other comorbidities. In summary, these challenges will also need to be addressed as the CLI field continues to mature in the twenty-first century.
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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: The Contemporary Role of Stents and Angioplasty for the Treatment of Infrapopliteal Disease in Critical Limb Ischemia ###Abstract: Purpose of Review: Critical limb ischemia (CLI) is associated with significant morbidity, mortality, and increased health care expenses. Revascularization has a central role in the treatment of CLI. Following publication of BASIL (bypass versus angioplasty in severe ischemia of the leg) trial a decade ago, an “endovascular first” approach had gained momentum and the technologies available for endovascular therapy have exponentially increased. Both the development of technology and technique, highlighted in this review, have allowed operators to treat complex infrapopliteal lesions which are central to CLI pathology. Recent Findings: The role of atherectomy remains controversial but for calcified lesions it has become an accepted adjunctive tool for plaque modification. The place of drug delivery technologies requires further trials. The use of a drug-coated balloon (DCB) makes intuitive sense; however, choice of excipient, lower limit of vessel size, and impact on remodeling and thrombosis remain uncertain. Summary: The optimal treatment of infrapopliteal disease remains an area of active investigation. The endpoints in CLI trials continue to be challenging and calibration of patency in relation to wound healing remains a moving target. In addition, unaccounted variables continue to confound interpretation of CLI trials—including quality and nature of wound care, status of pedal-plantar loop patency, and management of underlying diabetes and other comorbidities. In summary, these challenges will also need to be addressed as the CLI field continues to mature in the twenty-first century. [/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 Contemporary Role of Stents and Angioplasty for the Treatment of Infrapopliteal Disease in Critical Limb Ischemia ###Abstract: Purpose of Review: Critical limb ischemia (CLI) is associated with significant morbidity, mortality, and increased health care expenses. Revascularization has a central role in the treatment of CLI. Following publication of BASIL (bypass versus angioplasty in severe ischemia of the leg) trial a decade ago, an “endovascular first” approach had gained momentum and the technologies available for endovascular therapy have exponentially increased. Both the development of technology and technique, highlighted in this review, have allowed operators to treat complex infrapopliteal lesions which are central to CLI pathology. Recent Findings: The role of atherectomy remains controversial but for calcified lesions it has become an accepted adjunctive tool for plaque modification. The place of drug delivery technologies requires further trials. The use of a drug-coated balloon (DCB) makes intuitive sense; however, choice of excipient, lower limit of vessel size, and impact on remodeling and thrombosis remain uncertain. Summary: The optimal treatment of infrapopliteal disease remains an area of active investigation. The endpoints in CLI trials continue to be challenging and calibration of patency in relation to wound healing remains a moving target. In addition, unaccounted variables continue to confound interpretation of CLI trials—including quality and nature of wound care, status of pedal-plantar loop patency, and management of underlying diabetes and other comorbidities. In summary, these challenges will also need to be addressed as the CLI field continues to mature in the twenty-first century. [/INST] Exclude </s>
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Heid 2017
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Interventional treatment of the left subclavian in 2 patients with coronary steal syndrome
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In patients with history of coronary artery disease angina pectoris is usually attributed to the progression of atherosclerotic lesions. However, in patients with previous coronary artery bypass graft operation (CABG) using internal mammary artery grafts, great vessel disease should also be considered. Herein we present two patients with history of CABG whose symptoms were suspicious for coronary ischemia. During cardiac catheterization reverse blood flow was observed from the left artery disease to the left internal mammary artery (LIMA) graft in both cases. After angioplasty and stent implantation of the left subclavian artery antegrade flow was restored in the LIMA grafts and both patients had complete resolution of symptoms.
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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: Interventional treatment of the left subclavian in 2 patients with coronary steal syndrome ###Abstract: In patients with history of coronary artery disease angina pectoris is usually attributed to the progression of atherosclerotic lesions. However, in patients with previous coronary artery bypass graft operation (CABG) using internal mammary artery grafts, great vessel disease should also be considered. Herein we present two patients with history of CABG whose symptoms were suspicious for coronary ischemia. During cardiac catheterization reverse blood flow was observed from the left artery disease to the left internal mammary artery (LIMA) graft in both cases. After angioplasty and stent implantation of the left subclavian artery antegrade flow was restored in the LIMA grafts and both patients had complete resolution of symptoms. [/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: Interventional treatment of the left subclavian in 2 patients with coronary steal syndrome ###Abstract: In patients with history of coronary artery disease angina pectoris is usually attributed to the progression of atherosclerotic lesions. However, in patients with previous coronary artery bypass graft operation (CABG) using internal mammary artery grafts, great vessel disease should also be considered. Herein we present two patients with history of CABG whose symptoms were suspicious for coronary ischemia. During cardiac catheterization reverse blood flow was observed from the left artery disease to the left internal mammary artery (LIMA) graft in both cases. After angioplasty and stent implantation of the left subclavian artery antegrade flow was restored in the LIMA grafts and both patients had complete resolution of symptoms. [/INST] Exclude </s>
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Her 2018
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Impact of paclitaxel-coated balloon versus newer-generation drug-eluting stent on periprocedural myocardial infarction in stable angina patients
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Objectives Periprocedural myocardial infarction (PMI) is reported to be associated with adverse long-term clinical outcomes. This study compared the rates of PMI following treatment of de novo coronary lesions using either a paclitaxel-coated balloon (PCB) or a newer-generation drug-eluting stent (DES). Patients and methods We compared the incidence of PMI in propensity-matched patients with stable angina pectoris and single-vessel de novo coronary lesions who underwent treatment with a PCB or newer-generation DES. Propensity score matching was performed to adjust for differences in baseline clinical and angiographic characteristics. Results After propensity matching, the study cohort included 108 patients (PCB: n=54 and DES: n=54). The peak mean values of creatine kinase-myocardial band (13.3±26.3 vs. 2.2±2.8 ng/ml, P=0.003) and high-sensitive troponin T (0.62±1.38 vs. 0.09±0.19 ng/ml, P=0.007) were significantly higher in the DES group compared with the PCB group. The incidence of PMI was significantly higher in the DES group [DES: 11 (20.4%) vs. PCB: one (1.9%); P=0.002]. Total occlusion of the side-branch occurred in two patients treated with DES, but no patients treated with PCB. Treatment with a newer-generation DES was found to be an independent predictor of PMI on multivariable analyses. Conclusion In patients with stable angina using a PCB, compared with deployment of a newer-generation DES, is associated with a significant reduction in the risk of PMI.
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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: Impact of paclitaxel-coated balloon versus newer-generation drug-eluting stent on periprocedural myocardial infarction in stable angina patients ###Abstract: Objectives Periprocedural myocardial infarction (PMI) is reported to be associated with adverse long-term clinical outcomes. This study compared the rates of PMI following treatment of de novo coronary lesions using either a paclitaxel-coated balloon (PCB) or a newer-generation drug-eluting stent (DES). Patients and methods We compared the incidence of PMI in propensity-matched patients with stable angina pectoris and single-vessel de novo coronary lesions who underwent treatment with a PCB or newer-generation DES. Propensity score matching was performed to adjust for differences in baseline clinical and angiographic characteristics. Results After propensity matching, the study cohort included 108 patients (PCB: n=54 and DES: n=54). The peak mean values of creatine kinase-myocardial band (13.3±26.3 vs. 2.2±2.8 ng/ml, P=0.003) and high-sensitive troponin T (0.62±1.38 vs. 0.09±0.19 ng/ml, P=0.007) were significantly higher in the DES group compared with the PCB group. The incidence of PMI was significantly higher in the DES group [DES: 11 (20.4%) vs. PCB: one (1.9%); P=0.002]. Total occlusion of the side-branch occurred in two patients treated with DES, but no patients treated with PCB. Treatment with a newer-generation DES was found to be an independent predictor of PMI on multivariable analyses. Conclusion In patients with stable angina using a PCB, compared with deployment of a newer-generation DES, is associated with a significant reduction in the risk of PMI. [/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 paclitaxel-coated balloon versus newer-generation drug-eluting stent on periprocedural myocardial infarction in stable angina patients ###Abstract: Objectives Periprocedural myocardial infarction (PMI) is reported to be associated with adverse long-term clinical outcomes. This study compared the rates of PMI following treatment of de novo coronary lesions using either a paclitaxel-coated balloon (PCB) or a newer-generation drug-eluting stent (DES). Patients and methods We compared the incidence of PMI in propensity-matched patients with stable angina pectoris and single-vessel de novo coronary lesions who underwent treatment with a PCB or newer-generation DES. Propensity score matching was performed to adjust for differences in baseline clinical and angiographic characteristics. Results After propensity matching, the study cohort included 108 patients (PCB: n=54 and DES: n=54). The peak mean values of creatine kinase-myocardial band (13.3±26.3 vs. 2.2±2.8 ng/ml, P=0.003) and high-sensitive troponin T (0.62±1.38 vs. 0.09±0.19 ng/ml, P=0.007) were significantly higher in the DES group compared with the PCB group. The incidence of PMI was significantly higher in the DES group [DES: 11 (20.4%) vs. PCB: one (1.9%); P=0.002]. Total occlusion of the side-branch occurred in two patients treated with DES, but no patients treated with PCB. Treatment with a newer-generation DES was found to be an independent predictor of PMI on multivariable analyses. Conclusion In patients with stable angina using a PCB, compared with deployment of a newer-generation DES, is associated with a significant reduction in the risk of PMI. [/INST] Exclude </s>
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Herten 2016
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Critical appraisal of paclitaxel balloon angioplasty for femoral-popliteal arterial disease
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Peripheral arterial disease, particularly critical limb ischemia, is an area with urgent need for optimized therapies because, to date, vascular interventions often have limited life spans.In spite of initial encouraging technical success after femoropopliteal percutaneous transluminal angioplasty or stenting, postprocedural restenosis remains the major problem.The challenging idea behind the drug-coated balloon (DCB) concept is the biological modification of the injury response after balloon dilatation.Antiproliferative drugs administered via DCBs or drug-eluting stents are able to suppress neointimal hyperplasia, the main cause of restenosis.This article reviews the results of DCB treatments of femoropopliteal and infrapopliteal lesions in comparison to standard angioplasty with uncoated balloons.A systematic literature search was performed in 1) medical journals (ie, MEDLINE), 2) international registers for clinical studies (ie, www.clinicaltrials.gov), and 3) abstracts of scientific sessions.Several controlled randomized trials with follow-up periods of up to 5 years demonstrated the efficacy of paclitaxel -DCB technology.However, calcified lesions seem to affect the efficacy of DCB.Combinations of preconditioning methods with DCBs showed promising results.Although the mechanical abrasion of calcium via atherectomy or laser ablation showed favorable periprocedural results, the long-term impact on restenosis and clinical outcome has to be demonstrated.Major advantages of the DCBs are the rapid delivery of drug at uniform concentrations with a single dose, their efficacy in areas wherein stents have been contraindicated until now (ie, bifurcation, ostial lesions), and in leaving no stent scaffold behind.Reinterventions are easier to perform because DCBs leave no metal behind.Various combinations of DCBs with other treatment modalities may prove to be viable options in future.The follow-up results of clinical studies will evaluate the long-term impact 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: Critical appraisal of paclitaxel balloon angioplasty for femoral-popliteal arterial disease ###Abstract: Peripheral arterial disease, particularly critical limb ischemia, is an area with urgent need for optimized therapies because, to date, vascular interventions often have limited life spans.In spite of initial encouraging technical success after femoropopliteal percutaneous transluminal angioplasty or stenting, postprocedural restenosis remains the major problem.The challenging idea behind the drug-coated balloon (DCB) concept is the biological modification of the injury response after balloon dilatation.Antiproliferative drugs administered via DCBs or drug-eluting stents are able to suppress neointimal hyperplasia, the main cause of restenosis.This article reviews the results of DCB treatments of femoropopliteal and infrapopliteal lesions in comparison to standard angioplasty with uncoated balloons.A systematic literature search was performed in 1) medical journals (ie, MEDLINE), 2) international registers for clinical studies (ie, www.clinicaltrials.gov), and 3) abstracts of scientific sessions.Several controlled randomized trials with follow-up periods of up to 5 years demonstrated the efficacy of paclitaxel -DCB technology.However, calcified lesions seem to affect the efficacy of DCB.Combinations of preconditioning methods with DCBs showed promising results.Although the mechanical abrasion of calcium via atherectomy or laser ablation showed favorable periprocedural results, the long-term impact on restenosis and clinical outcome has to be demonstrated.Major advantages of the DCBs are the rapid delivery of drug at uniform concentrations with a single dose, their efficacy in areas wherein stents have been contraindicated until now (ie, bifurcation, ostial lesions), and in leaving no stent scaffold behind.Reinterventions are easier to perform because DCBs leave no metal behind.Various combinations of DCBs with other treatment modalities may prove to be viable options in future.The follow-up results of clinical studies will evaluate the long-term impact 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: Critical appraisal of paclitaxel balloon angioplasty for femoral-popliteal arterial disease ###Abstract: Peripheral arterial disease, particularly critical limb ischemia, is an area with urgent need for optimized therapies because, to date, vascular interventions often have limited life spans.In spite of initial encouraging technical success after femoropopliteal percutaneous transluminal angioplasty or stenting, postprocedural restenosis remains the major problem.The challenging idea behind the drug-coated balloon (DCB) concept is the biological modification of the injury response after balloon dilatation.Antiproliferative drugs administered via DCBs or drug-eluting stents are able to suppress neointimal hyperplasia, the main cause of restenosis.This article reviews the results of DCB treatments of femoropopliteal and infrapopliteal lesions in comparison to standard angioplasty with uncoated balloons.A systematic literature search was performed in 1) medical journals (ie, MEDLINE), 2) international registers for clinical studies (ie, www.clinicaltrials.gov), and 3) abstracts of scientific sessions.Several controlled randomized trials with follow-up periods of up to 5 years demonstrated the efficacy of paclitaxel -DCB technology.However, calcified lesions seem to affect the efficacy of DCB.Combinations of preconditioning methods with DCBs showed promising results.Although the mechanical abrasion of calcium via atherectomy or laser ablation showed favorable periprocedural results, the long-term impact on restenosis and clinical outcome has to be demonstrated.Major advantages of the DCBs are the rapid delivery of drug at uniform concentrations with a single dose, their efficacy in areas wherein stents have been contraindicated until now (ie, bifurcation, ostial lesions), and in leaving no stent scaffold behind.Reinterventions are easier to perform because DCBs leave no metal behind.Various combinations of DCBs with other treatment modalities may prove to be viable options in future.The follow-up results of clinical studies will evaluate the long-term impact of DCBs. [/INST] Exclude </s>
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Ho 2017
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Diagnosis, classification, and treatment of femoropopliteal artery in-stent restenosis
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In-stent restenosis is a pervasive challenge to the durability of stenting for the treatment of lower extremity ischemia. There is considerable controversy about the criteria for diagnosis, indications for treatment, and preferred algorithm for addressing in-stent restenosis. This evidence summary seeks to review existing information on strategies for the treatment of this difficult problem.
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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: Diagnosis, classification, and treatment of femoropopliteal artery in-stent restenosis ###Abstract: In-stent restenosis is a pervasive challenge to the durability of stenting for the treatment of lower extremity ischemia. There is considerable controversy about the criteria for diagnosis, indications for treatment, and preferred algorithm for addressing in-stent restenosis. This evidence summary seeks to review existing information on strategies for the treatment of this difficult problem. [/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: Diagnosis, classification, and treatment of femoropopliteal artery in-stent restenosis ###Abstract: In-stent restenosis is a pervasive challenge to the durability of stenting for the treatment of lower extremity ischemia. There is considerable controversy about the criteria for diagnosis, indications for treatment, and preferred algorithm for addressing in-stent restenosis. This evidence summary seeks to review existing information on strategies for the treatment of this difficult problem. [/INST] Exclude </s>
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Hsieh 2018
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Predictors of Long-Term Outcomes After Drug-Eluting Balloon Angioplasty for Bare-Metal Stent Restenosis
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Background: Clinical trials have investigated efficacy of drug-eluting balloon (DEB) angioplasty for bare-metal stent (BMS) in-stent restenosis (ISR). Few studies have investigated predictors of long-term outcomes following BMS-ISR treatment with DEB. Methods: From June 2011 to April 2015, 105 patients with 125 BMS-ISR lesions were enrolled from the Cardiovascular Atherosclerosis and Percutaneous TrAnsluminal INterventions (CAPTAIN) registry. All these lesions were treated with DEB angioplasty as final therapy. The major adverse cardiac events (MACEs) were recurrent clinically driven target lesion revascularisation (TLR), myocardial infarction, and cardiac death after DEB angioplasty. Results: After DEB angioplasty, the angiographic stenosis decreased from 84.8% ± 12.4% to 22.6% ± 10.4%. Over a mean follow-up duration of 21.7 ± 13.4 months, the rates of TLR at 1–12 months and 12–48 months were 4.8% and 4.2%, respectively. The rates of MACEs at 1–12 months and 12–48 months were 6.7% and 6.1%, respectively. Chronic haemodialysis, calcified lesion, chronic total occlusion lesion before stenting, stent with metal-to-artery ratio >16.5%, and residual stenosis >25% after DEB angioplasty were potential risk factors for MACEs in univariate analysis. After adjustment in multivariate analysis, independent predictors of long-term MACEs were identified as chronic haemodialysis, chronic total occlusion lesion before stenting, and residual stenosis >25% after DEB angioplasty. Conclusions: The long-term results of DEB angioplasty for BMS-ISR are acceptable in this real-world registry. Patient (chronic haemodialysis), lesion (chronic total occlusion) and angioplasty (residual stenosis percentage) related factors predicted long-term outcomes following BMS-ISR treatment with DEB angioplasty.
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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: Predictors of Long-Term Outcomes After Drug-Eluting Balloon Angioplasty for Bare-Metal Stent Restenosis ###Abstract: Background: Clinical trials have investigated efficacy of drug-eluting balloon (DEB) angioplasty for bare-metal stent (BMS) in-stent restenosis (ISR). Few studies have investigated predictors of long-term outcomes following BMS-ISR treatment with DEB. Methods: From June 2011 to April 2015, 105 patients with 125 BMS-ISR lesions were enrolled from the Cardiovascular Atherosclerosis and Percutaneous TrAnsluminal INterventions (CAPTAIN) registry. All these lesions were treated with DEB angioplasty as final therapy. The major adverse cardiac events (MACEs) were recurrent clinically driven target lesion revascularisation (TLR), myocardial infarction, and cardiac death after DEB angioplasty. Results: After DEB angioplasty, the angiographic stenosis decreased from 84.8% ± 12.4% to 22.6% ± 10.4%. Over a mean follow-up duration of 21.7 ± 13.4 months, the rates of TLR at 1–12 months and 12–48 months were 4.8% and 4.2%, respectively. The rates of MACEs at 1–12 months and 12–48 months were 6.7% and 6.1%, respectively. Chronic haemodialysis, calcified lesion, chronic total occlusion lesion before stenting, stent with metal-to-artery ratio >16.5%, and residual stenosis >25% after DEB angioplasty were potential risk factors for MACEs in univariate analysis. After adjustment in multivariate analysis, independent predictors of long-term MACEs were identified as chronic haemodialysis, chronic total occlusion lesion before stenting, and residual stenosis >25% after DEB angioplasty. Conclusions: The long-term results of DEB angioplasty for BMS-ISR are acceptable in this real-world registry. Patient (chronic haemodialysis), lesion (chronic total occlusion) and angioplasty (residual stenosis percentage) related factors predicted long-term outcomes following BMS-ISR treatment with DEB angioplasty. [/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: Predictors of Long-Term Outcomes After Drug-Eluting Balloon Angioplasty for Bare-Metal Stent Restenosis ###Abstract: Background: Clinical trials have investigated efficacy of drug-eluting balloon (DEB) angioplasty for bare-metal stent (BMS) in-stent restenosis (ISR). Few studies have investigated predictors of long-term outcomes following BMS-ISR treatment with DEB. Methods: From June 2011 to April 2015, 105 patients with 125 BMS-ISR lesions were enrolled from the Cardiovascular Atherosclerosis and Percutaneous TrAnsluminal INterventions (CAPTAIN) registry. All these lesions were treated with DEB angioplasty as final therapy. The major adverse cardiac events (MACEs) were recurrent clinically driven target lesion revascularisation (TLR), myocardial infarction, and cardiac death after DEB angioplasty. Results: After DEB angioplasty, the angiographic stenosis decreased from 84.8% ± 12.4% to 22.6% ± 10.4%. Over a mean follow-up duration of 21.7 ± 13.4 months, the rates of TLR at 1–12 months and 12–48 months were 4.8% and 4.2%, respectively. The rates of MACEs at 1–12 months and 12–48 months were 6.7% and 6.1%, respectively. Chronic haemodialysis, calcified lesion, chronic total occlusion lesion before stenting, stent with metal-to-artery ratio >16.5%, and residual stenosis >25% after DEB angioplasty were potential risk factors for MACEs in univariate analysis. After adjustment in multivariate analysis, independent predictors of long-term MACEs were identified as chronic haemodialysis, chronic total occlusion lesion before stenting, and residual stenosis >25% after DEB angioplasty. Conclusions: The long-term results of DEB angioplasty for BMS-ISR are acceptable in this real-world registry. Patient (chronic haemodialysis), lesion (chronic total occlusion) and angioplasty (residual stenosis percentage) related factors predicted long-term outcomes following BMS-ISR treatment with DEB angioplasty. [/INST] Exclude </s>
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Iancu 2016
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How should i treat renal artery in-stent restenosis and stent fracture after endovascular abdominal aortic aneurysm repair?
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BACKGROUND: A 68-year-old man with a history of prior endovascular abdominal aortic aneurysm repair, with recurrent flash pulmonary oedema and renal artery revascularisation including redo renal artery interventions for in-stent restenosis, presented to our department with renal failure, severe uncontrolled high blood pressure and left renal stent fracture. The patient was prepared for a third renal revascularisation procedure. INVESTIGATION: Renal angiography, intravascular ultrasound, renal duplex imaging DIAGNOSIS: Renal artery in-stent restenosis and stent fracture after endovascular abdominal aortic aneurysm repair. MANAGEMENT: Left renal artery stenting was performed using a Hippocampus 6×24 mm renal stent which was preferred to a drug-eluting stent.
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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: How should i treat renal artery in-stent restenosis and stent fracture after endovascular abdominal aortic aneurysm repair? ###Abstract: BACKGROUND: A 68-year-old man with a history of prior endovascular abdominal aortic aneurysm repair, with recurrent flash pulmonary oedema and renal artery revascularisation including redo renal artery interventions for in-stent restenosis, presented to our department with renal failure, severe uncontrolled high blood pressure and left renal stent fracture. The patient was prepared for a third renal revascularisation procedure. INVESTIGATION: Renal angiography, intravascular ultrasound, renal duplex imaging DIAGNOSIS: Renal artery in-stent restenosis and stent fracture after endovascular abdominal aortic aneurysm repair. MANAGEMENT: Left renal artery stenting was performed using a Hippocampus 6×24 mm renal stent which was preferred to a drug-eluting stent. [/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: How should i treat renal artery in-stent restenosis and stent fracture after endovascular abdominal aortic aneurysm repair? ###Abstract: BACKGROUND: A 68-year-old man with a history of prior endovascular abdominal aortic aneurysm repair, with recurrent flash pulmonary oedema and renal artery revascularisation including redo renal artery interventions for in-stent restenosis, presented to our department with renal failure, severe uncontrolled high blood pressure and left renal stent fracture. The patient was prepared for a third renal revascularisation procedure. INVESTIGATION: Renal angiography, intravascular ultrasound, renal duplex imaging DIAGNOSIS: Renal artery in-stent restenosis and stent fracture after endovascular abdominal aortic aneurysm repair. MANAGEMENT: Left renal artery stenting was performed using a Hippocampus 6×24 mm renal stent which was preferred to a drug-eluting stent. [/INST] Exclude </s>
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Ielasi 2016
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Hybrid strategy with a bioresorbable scaffold and a drug-coated balloon for diffuse coronary artery disease: The "no more metallic cages" multicentre pilot experience
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Aims: Our aim was to assess the feasibility and results of a hybrid approach with a bioresorbable scaffold (BRS) plus a drug-coated balloon (DCB) for the treatment of diffuse coronary artery disease (CAD). Methods and results: A retrospective analysis was performed on consecutive patients with diffuse de novo or in-stent restenosis treated with BRS implantation (larger proximal segment) and DCB inflation (smaller distal segment or bifurcation side branch). Endpoints were procedural success, then ischaemia-driven target lesion revascularisation (ID-TLR) and BRS/DCB segment thrombosis rates at follow-up. A total of 42 consecutive patients were treated with the hybrid strategy. Mean patient age was 62±1.02 years, while 12 (28.6%) patients were diabetics. Mean BRS and DCB length were 28.0±5.1 mm and 25.8±8.8 mm, respectively. Procedural success was obtained in all patients, but three (7.3%) patients required bail-out scaffolding for DCB-related dissection. At a median follow-up of 12 months (IQR: 6-18), there were no cases of cardiac death, target vessel myocardial infarction, or BRS/DCB segment thrombosis. ID-TLR occurred in two (4.7%) BRS-treated segments. Conclusions: Our data in consecutive patients with diffuse CAD suggest that a hybrid strategy using BRS and DCB in different segments of the diseased vessel is feasible and associated with encouraging clinical outcomes.
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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: Hybrid strategy with a bioresorbable scaffold and a drug-coated balloon for diffuse coronary artery disease: The "no more metallic cages" multicentre pilot experience ###Abstract: Aims: Our aim was to assess the feasibility and results of a hybrid approach with a bioresorbable scaffold (BRS) plus a drug-coated balloon (DCB) for the treatment of diffuse coronary artery disease (CAD). Methods and results: A retrospective analysis was performed on consecutive patients with diffuse de novo or in-stent restenosis treated with BRS implantation (larger proximal segment) and DCB inflation (smaller distal segment or bifurcation side branch). Endpoints were procedural success, then ischaemia-driven target lesion revascularisation (ID-TLR) and BRS/DCB segment thrombosis rates at follow-up. A total of 42 consecutive patients were treated with the hybrid strategy. Mean patient age was 62±1.02 years, while 12 (28.6%) patients were diabetics. Mean BRS and DCB length were 28.0±5.1 mm and 25.8±8.8 mm, respectively. Procedural success was obtained in all patients, but three (7.3%) patients required bail-out scaffolding for DCB-related dissection. At a median follow-up of 12 months (IQR: 6-18), there were no cases of cardiac death, target vessel myocardial infarction, or BRS/DCB segment thrombosis. ID-TLR occurred in two (4.7%) BRS-treated segments. Conclusions: Our data in consecutive patients with diffuse CAD suggest that a hybrid strategy using BRS and DCB in different segments of the diseased vessel is feasible and associated with encouraging clinical outcomes. [/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: Hybrid strategy with a bioresorbable scaffold and a drug-coated balloon for diffuse coronary artery disease: The "no more metallic cages" multicentre pilot experience ###Abstract: Aims: Our aim was to assess the feasibility and results of a hybrid approach with a bioresorbable scaffold (BRS) plus a drug-coated balloon (DCB) for the treatment of diffuse coronary artery disease (CAD). Methods and results: A retrospective analysis was performed on consecutive patients with diffuse de novo or in-stent restenosis treated with BRS implantation (larger proximal segment) and DCB inflation (smaller distal segment or bifurcation side branch). Endpoints were procedural success, then ischaemia-driven target lesion revascularisation (ID-TLR) and BRS/DCB segment thrombosis rates at follow-up. A total of 42 consecutive patients were treated with the hybrid strategy. Mean patient age was 62±1.02 years, while 12 (28.6%) patients were diabetics. Mean BRS and DCB length were 28.0±5.1 mm and 25.8±8.8 mm, respectively. Procedural success was obtained in all patients, but three (7.3%) patients required bail-out scaffolding for DCB-related dissection. At a median follow-up of 12 months (IQR: 6-18), there were no cases of cardiac death, target vessel myocardial infarction, or BRS/DCB segment thrombosis. ID-TLR occurred in two (4.7%) BRS-treated segments. Conclusions: Our data in consecutive patients with diffuse CAD suggest that a hybrid strategy using BRS and DCB in different segments of the diseased vessel is feasible and associated with encouraging clinical outcomes. [/INST] Exclude </s>
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Imran 2019
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Efficacy and safety of adjunctive drug-coated balloon therapy in endovascular treatment of common femoral artery disease
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Background: Surgical endarterectomy with or without patch angioplasty has been considered the gold standard for treatment of symptomatic common femoral artery (CFA) disease. Surgical risks include wound infection, hematoma and lymph leak in approximately 17% of patients. Endovascular therapy has less procedure-related morbidity and mortality. Endovascular approaches achieve patency rates of 60% to 90% at 1 and 2 years utilizing atherectomy and balloon angioplasty. CFA stenting has been limited due to concerns of stent kinking, thrombosis and restenosis. Combined directional atherectomy with drug-coated balloon to treat CFA disease in patients with Rutherford II/III patients has been studied recently. We sought to study the safety and outcomes of adjunct drug-coated balloon (DCB) therapy in symptomatic CFA disease patients, including critical limb ischemia (Rutherford IV), after achieving procedural success. Objective: To evaluate the additive efficacy of drug coated balloon in treating CFA disease. Methods: Using retrospective single center data, we analyzed the outcomes of patients who underwent CFA interventions. In this non-randomized study, all patients from December 2010 to December 2014 with CFA disease underwent atherectomy (orbital, plaque excision or both) with adjunctive scoring balloon angioplasty (Ath/PTA). After December 2014, patients treated with combination atherectomy and DCB, (Ath/DCB), underwent final drug delivery to the vessel wall with drug-coated balloon. Distal embolic protection devices were used in the majority of patients. Primary efficacy endpoint was 1-year primary patency and freedom from clinically driven target lesion revascularization (CD-TLR). Patency of vessels was assessed at 12-month interval using duplex ultrasound. Results: Seventy de novo common femoral artery stenotic lesions were treated in both groups. Mean age was 69 in (Ath/PTA) group and 72 in Ath/DCB group. Patients in each group had similar risk factor profiles including diabetes mellitus, hypertension, smoking, coronary artery disease, myocardial infarction, prior coronary revascularization, congestive heart failure, cerebrovascular accidents and chronic kidney disease. The Ath/DCB group had more advanced disease presentation by Rutherford classification (intermittent claudication in 61% and critical limb ischemia in 39% versus intermittent claudication in 76% and chronic limb ischemia in 24%) when compared with the Ath/PTA group. Primary efficacy endpoint was met in 85% and 94% (p = 0.26) in the Ath/PTA and Ath/DCB groups respectively. All patients had run-off angiography at the end of procedure to ensure patency. Conclusion: Adjunctive drug-coated balloon therapy does not increase the primary patency rate when compared with atherectomy and scoring balloon angioplasty alone at 1-year in common femoral artery disease treatment.
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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: Efficacy and safety of adjunctive drug-coated balloon therapy in endovascular treatment of common femoral artery disease ###Abstract: Background: Surgical endarterectomy with or without patch angioplasty has been considered the gold standard for treatment of symptomatic common femoral artery (CFA) disease. Surgical risks include wound infection, hematoma and lymph leak in approximately 17% of patients. Endovascular therapy has less procedure-related morbidity and mortality. Endovascular approaches achieve patency rates of 60% to 90% at 1 and 2 years utilizing atherectomy and balloon angioplasty. CFA stenting has been limited due to concerns of stent kinking, thrombosis and restenosis. Combined directional atherectomy with drug-coated balloon to treat CFA disease in patients with Rutherford II/III patients has been studied recently. We sought to study the safety and outcomes of adjunct drug-coated balloon (DCB) therapy in symptomatic CFA disease patients, including critical limb ischemia (Rutherford IV), after achieving procedural success. Objective: To evaluate the additive efficacy of drug coated balloon in treating CFA disease. Methods: Using retrospective single center data, we analyzed the outcomes of patients who underwent CFA interventions. In this non-randomized study, all patients from December 2010 to December 2014 with CFA disease underwent atherectomy (orbital, plaque excision or both) with adjunctive scoring balloon angioplasty (Ath/PTA). After December 2014, patients treated with combination atherectomy and DCB, (Ath/DCB), underwent final drug delivery to the vessel wall with drug-coated balloon. Distal embolic protection devices were used in the majority of patients. Primary efficacy endpoint was 1-year primary patency and freedom from clinically driven target lesion revascularization (CD-TLR). Patency of vessels was assessed at 12-month interval using duplex ultrasound. Results: Seventy de novo common femoral artery stenotic lesions were treated in both groups. Mean age was 69 in (Ath/PTA) group and 72 in Ath/DCB group. Patients in each group had similar risk factor profiles including diabetes mellitus, hypertension, smoking, coronary artery disease, myocardial infarction, prior coronary revascularization, congestive heart failure, cerebrovascular accidents and chronic kidney disease. The Ath/DCB group had more advanced disease presentation by Rutherford classification (intermittent claudication in 61% and critical limb ischemia in 39% versus intermittent claudication in 76% and chronic limb ischemia in 24%) when compared with the Ath/PTA group. Primary efficacy endpoint was met in 85% and 94% (p = 0.26) in the Ath/PTA and Ath/DCB groups respectively. All patients had run-off angiography at the end of procedure to ensure patency. Conclusion: Adjunctive drug-coated balloon therapy does not increase the primary patency rate when compared with atherectomy and scoring balloon angioplasty alone at 1-year in common femoral artery disease 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: Efficacy and safety of adjunctive drug-coated balloon therapy in endovascular treatment of common femoral artery disease ###Abstract: Background: Surgical endarterectomy with or without patch angioplasty has been considered the gold standard for treatment of symptomatic common femoral artery (CFA) disease. Surgical risks include wound infection, hematoma and lymph leak in approximately 17% of patients. Endovascular therapy has less procedure-related morbidity and mortality. Endovascular approaches achieve patency rates of 60% to 90% at 1 and 2 years utilizing atherectomy and balloon angioplasty. CFA stenting has been limited due to concerns of stent kinking, thrombosis and restenosis. Combined directional atherectomy with drug-coated balloon to treat CFA disease in patients with Rutherford II/III patients has been studied recently. We sought to study the safety and outcomes of adjunct drug-coated balloon (DCB) therapy in symptomatic CFA disease patients, including critical limb ischemia (Rutherford IV), after achieving procedural success. Objective: To evaluate the additive efficacy of drug coated balloon in treating CFA disease. Methods: Using retrospective single center data, we analyzed the outcomes of patients who underwent CFA interventions. In this non-randomized study, all patients from December 2010 to December 2014 with CFA disease underwent atherectomy (orbital, plaque excision or both) with adjunctive scoring balloon angioplasty (Ath/PTA). After December 2014, patients treated with combination atherectomy and DCB, (Ath/DCB), underwent final drug delivery to the vessel wall with drug-coated balloon. Distal embolic protection devices were used in the majority of patients. Primary efficacy endpoint was 1-year primary patency and freedom from clinically driven target lesion revascularization (CD-TLR). Patency of vessels was assessed at 12-month interval using duplex ultrasound. Results: Seventy de novo common femoral artery stenotic lesions were treated in both groups. Mean age was 69 in (Ath/PTA) group and 72 in Ath/DCB group. Patients in each group had similar risk factor profiles including diabetes mellitus, hypertension, smoking, coronary artery disease, myocardial infarction, prior coronary revascularization, congestive heart failure, cerebrovascular accidents and chronic kidney disease. The Ath/DCB group had more advanced disease presentation by Rutherford classification (intermittent claudication in 61% and critical limb ischemia in 39% versus intermittent claudication in 76% and chronic limb ischemia in 24%) when compared with the Ath/PTA group. Primary efficacy endpoint was met in 85% and 94% (p = 0.26) in the Ath/PTA and Ath/DCB groups respectively. All patients had run-off angiography at the end of procedure to ensure patency. Conclusion: Adjunctive drug-coated balloon therapy does not increase the primary patency rate when compared with atherectomy and scoring balloon angioplasty alone at 1-year in common femoral artery disease treatment. [/INST] Exclude </s>
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Januszek 2016
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The successful retrieval of a broken guide wire from the diagonal branch of the left anterior descending coronary artery complicated by partial stent rolling
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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: The successful retrieval of a broken guide wire from the diagonal branch of the left anterior descending coronary artery complicated by partial stent rolling ###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: The successful retrieval of a broken guide wire from the diagonal branch of the left anterior descending coronary artery complicated by partial stent rolling ###Abstract: None [/INST] Exclude </s>
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Jongsma 2017
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Randomized comparison of femoropopliteal artery drug-eluting balloons and drug-eluting stents (FOREST trial): Study protocol for a randomized controlled trial
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The optimal endovascular treatment for femoropopliteal arterial occlusive disease has yet to be assessed. Patency rates after uncoated balloon angioplasty are disappointing. Although stents have better outcomes, they also have limitations. Intra-arterial stenting may lead to stent thrombosis and flow pattern disruption, which may result in stent fracture or in-stent restenosis. In the past decade, drug-eluting balloons (DEBs) and drug-eluting stents (DESs) have been introduced, and both have been proven to possess antirestenotic features compared with conventional techniques. The objective of this study is to perform a noninferiority analysis of DEBs with provisional bare-metal stenting and primary stenting with DESs in the treatment of femoropopliteal arterial occlusive disease. If DEB with provisional bare-metal stenting proves to be noninferior to primary stenting with DESs, DEBs may be the favorable technique because the postoperative long-term limitations of stents will be restricted. This is a prospective, randomized, controlled, single-blind, multicenter trial. The study population consists of volunteers aged ≥18 years, with chronic, symptomatic peripheral arterial occlusive disease (Rutherford-Baker classification 2 to 5) caused by de novo stenotic or occlusive atherosclerotic lesions of the superficial femoral artery or of the popliteal artery (only segment P1). Subjects will be treated with a DEB and provisional bare-metal stenting (if a stenosis >30% or a flow-limiting dissection persists after prolonged inflation with an uncoated balloon) or with primary stenting with a DES. The study will include 254 patients (ratio 1:1). The primary end point is 2-year freedom from binary restenosis, defined as a lumen diameter reduction of <50% assessed by duplex ultrasound imaging (peak systolic velocity ratio <2.5). Secondary end points are technical success, target lesion revascularization, target vessel revascularization, improvement in ankle-brachial index, improvement in Rutherford classification, amputation rate, and mortality rate.
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DE4 - Protocol
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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 comparison of femoropopliteal artery drug-eluting balloons and drug-eluting stents (FOREST trial): Study protocol for a randomized controlled trial ###Abstract: The optimal endovascular treatment for femoropopliteal arterial occlusive disease has yet to be assessed. Patency rates after uncoated balloon angioplasty are disappointing. Although stents have better outcomes, they also have limitations. Intra-arterial stenting may lead to stent thrombosis and flow pattern disruption, which may result in stent fracture or in-stent restenosis. In the past decade, drug-eluting balloons (DEBs) and drug-eluting stents (DESs) have been introduced, and both have been proven to possess antirestenotic features compared with conventional techniques. The objective of this study is to perform a noninferiority analysis of DEBs with provisional bare-metal stenting and primary stenting with DESs in the treatment of femoropopliteal arterial occlusive disease. If DEB with provisional bare-metal stenting proves to be noninferior to primary stenting with DESs, DEBs may be the favorable technique because the postoperative long-term limitations of stents will be restricted. This is a prospective, randomized, controlled, single-blind, multicenter trial. The study population consists of volunteers aged ≥18 years, with chronic, symptomatic peripheral arterial occlusive disease (Rutherford-Baker classification 2 to 5) caused by de novo stenotic or occlusive atherosclerotic lesions of the superficial femoral artery or of the popliteal artery (only segment P1). Subjects will be treated with a DEB and provisional bare-metal stenting (if a stenosis >30% or a flow-limiting dissection persists after prolonged inflation with an uncoated balloon) or with primary stenting with a DES. The study will include 254 patients (ratio 1:1). The primary end point is 2-year freedom from binary restenosis, defined as a lumen diameter reduction of <50% assessed by duplex ultrasound imaging (peak systolic velocity ratio <2.5). Secondary end points are technical success, target lesion revascularization, target vessel revascularization, improvement in ankle-brachial index, improvement in Rutherford classification, amputation rate, and mortality rate. [/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 comparison of femoropopliteal artery drug-eluting balloons and drug-eluting stents (FOREST trial): Study protocol for a randomized controlled trial ###Abstract: The optimal endovascular treatment for femoropopliteal arterial occlusive disease has yet to be assessed. Patency rates after uncoated balloon angioplasty are disappointing. Although stents have better outcomes, they also have limitations. Intra-arterial stenting may lead to stent thrombosis and flow pattern disruption, which may result in stent fracture or in-stent restenosis. In the past decade, drug-eluting balloons (DEBs) and drug-eluting stents (DESs) have been introduced, and both have been proven to possess antirestenotic features compared with conventional techniques. The objective of this study is to perform a noninferiority analysis of DEBs with provisional bare-metal stenting and primary stenting with DESs in the treatment of femoropopliteal arterial occlusive disease. If DEB with provisional bare-metal stenting proves to be noninferior to primary stenting with DESs, DEBs may be the favorable technique because the postoperative long-term limitations of stents will be restricted. This is a prospective, randomized, controlled, single-blind, multicenter trial. The study population consists of volunteers aged ≥18 years, with chronic, symptomatic peripheral arterial occlusive disease (Rutherford-Baker classification 2 to 5) caused by de novo stenotic or occlusive atherosclerotic lesions of the superficial femoral artery or of the popliteal artery (only segment P1). Subjects will be treated with a DEB and provisional bare-metal stenting (if a stenosis >30% or a flow-limiting dissection persists after prolonged inflation with an uncoated balloon) or with primary stenting with a DES. The study will include 254 patients (ratio 1:1). The primary end point is 2-year freedom from binary restenosis, defined as a lumen diameter reduction of <50% assessed by duplex ultrasound imaging (peak systolic velocity ratio <2.5). Secondary end points are technical success, target lesion revascularization, target vessel revascularization, improvement in ankle-brachial index, improvement in Rutherford classification, amputation rate, and mortality rate. [/INST] Exclude </s>
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Kansal 2019
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Endovascular treatment of femoro-popliteal lesions
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Peripheral artery disease (PAD) is a major health concern affecting more than 200 million people worldwide and studies have shown PAD to be a strong predictor of mortality, morbidity, and disability. The management of PAD is multi-tiered and advancements in technology have given physicians more options for endovascular revascularization if medical therapy does not result in substantial improvement. Many randomized controlled trials have reported efficacy of various therapies including laser atherectomy, stent technology, and drug-coated balloons over standard percutaneous transluminal angioplasty; however, uncertainty regarding the best standard of care remains unclear because of a lack of head to head comparisons between novel therapies. Furthermore, variability in the reported clinical outcomes exists and makes it difficult to evaluate the superiority of any specific treatment modality, especially for functional capacity and quality of life. Recently established consensus definitions for clinical outcomes coupled with investigators incorporating direct comparisons within clinical trials will be crucial to establish consistent care and meaningful gain in treatment for these patients. This review will highlight the treatment modalities, literature supporting each treatment modality, and insight into why they are being used and why variation exists around the United States.
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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: Endovascular treatment of femoro-popliteal lesions ###Abstract: Peripheral artery disease (PAD) is a major health concern affecting more than 200 million people worldwide and studies have shown PAD to be a strong predictor of mortality, morbidity, and disability. The management of PAD is multi-tiered and advancements in technology have given physicians more options for endovascular revascularization if medical therapy does not result in substantial improvement. Many randomized controlled trials have reported efficacy of various therapies including laser atherectomy, stent technology, and drug-coated balloons over standard percutaneous transluminal angioplasty; however, uncertainty regarding the best standard of care remains unclear because of a lack of head to head comparisons between novel therapies. Furthermore, variability in the reported clinical outcomes exists and makes it difficult to evaluate the superiority of any specific treatment modality, especially for functional capacity and quality of life. Recently established consensus definitions for clinical outcomes coupled with investigators incorporating direct comparisons within clinical trials will be crucial to establish consistent care and meaningful gain in treatment for these patients. This review will highlight the treatment modalities, literature supporting each treatment modality, and insight into why they are being used and why variation exists around 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: Endovascular treatment of femoro-popliteal lesions ###Abstract: Peripheral artery disease (PAD) is a major health concern affecting more than 200 million people worldwide and studies have shown PAD to be a strong predictor of mortality, morbidity, and disability. The management of PAD is multi-tiered and advancements in technology have given physicians more options for endovascular revascularization if medical therapy does not result in substantial improvement. Many randomized controlled trials have reported efficacy of various therapies including laser atherectomy, stent technology, and drug-coated balloons over standard percutaneous transluminal angioplasty; however, uncertainty regarding the best standard of care remains unclear because of a lack of head to head comparisons between novel therapies. Furthermore, variability in the reported clinical outcomes exists and makes it difficult to evaluate the superiority of any specific treatment modality, especially for functional capacity and quality of life. Recently established consensus definitions for clinical outcomes coupled with investigators incorporating direct comparisons within clinical trials will be crucial to establish consistent care and meaningful gain in treatment for these patients. This review will highlight the treatment modalities, literature supporting each treatment modality, and insight into why they are being used and why variation exists around the United States. [/INST] Exclude </s>
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Kassimis 2019
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How Should We Treat Heavily Calcified Coronary Artery Disease in Contemporary Practice? From Atherectomy to Intravascular Lithotripsy
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Heavily calcified and densely fibrotic coronary lesions continue to represent a challenge for percutaneous coronary intervention (PCI), as they are difficult to dilate, and it is difficult to deliver and implant drug-eluting stents (DES) properly. Poor stent deployment is associated with high rates of periprocedural complications and suboptimal long-term clinical outcomes. Thanks to the introduction of several adjunctive PCI tools, like cutting and scoring balloons, atherectomy devices, and to the novel intravascular lithotripsy technology, the treatment of such lesions has become increasingly feasible, predictable and safe. A step-wise progression of strategies is described for coronary plaque modification, from well-recognised techniques to techniques that should only be considered when standard manoeuvres have proven unsuccessful. We highlight these techniques in the setting of clinical examples how best to apply them through better patient and lesion selection, with the main objective of optimising DES delivery and implantation, and subsequent improved outcomes.
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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: How Should We Treat Heavily Calcified Coronary Artery Disease in Contemporary Practice? From Atherectomy to Intravascular Lithotripsy ###Abstract: Heavily calcified and densely fibrotic coronary lesions continue to represent a challenge for percutaneous coronary intervention (PCI), as they are difficult to dilate, and it is difficult to deliver and implant drug-eluting stents (DES) properly. Poor stent deployment is associated with high rates of periprocedural complications and suboptimal long-term clinical outcomes. Thanks to the introduction of several adjunctive PCI tools, like cutting and scoring balloons, atherectomy devices, and to the novel intravascular lithotripsy technology, the treatment of such lesions has become increasingly feasible, predictable and safe. A step-wise progression of strategies is described for coronary plaque modification, from well-recognised techniques to techniques that should only be considered when standard manoeuvres have proven unsuccessful. We highlight these techniques in the setting of clinical examples how best to apply them through better patient and lesion selection, with the main objective of optimising DES delivery and implantation, and subsequent improved outcomes. [/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: How Should We Treat Heavily Calcified Coronary Artery Disease in Contemporary Practice? From Atherectomy to Intravascular Lithotripsy ###Abstract: Heavily calcified and densely fibrotic coronary lesions continue to represent a challenge for percutaneous coronary intervention (PCI), as they are difficult to dilate, and it is difficult to deliver and implant drug-eluting stents (DES) properly. Poor stent deployment is associated with high rates of periprocedural complications and suboptimal long-term clinical outcomes. Thanks to the introduction of several adjunctive PCI tools, like cutting and scoring balloons, atherectomy devices, and to the novel intravascular lithotripsy technology, the treatment of such lesions has become increasingly feasible, predictable and safe. A step-wise progression of strategies is described for coronary plaque modification, from well-recognised techniques to techniques that should only be considered when standard manoeuvres have proven unsuccessful. We highlight these techniques in the setting of clinical examples how best to apply them through better patient and lesion selection, with the main objective of optimising DES delivery and implantation, and subsequent improved outcomes. [/INST] Exclude </s>
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Kawai 2019
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Coronary restenosis of in-stent protruding bump with rapid progression: Optical frequency domain imaging and angioscopic observation
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In-stent restenosis (ISR) remains a tough problem after percutaneous coronary intervention (PCI) despite advances in technology of drug-eluting stents (DES). A 63-year-old man undergoing hemodialysis was diagnosed with non-ST elevation acute coronary syndrome (NSTE-ACS). An emergency coronary angiography (CAG) revealed severe stenosis in the middle left circumflex artery (LCx). After pre-dilatation with non-compliant balloon, primary PCI was successfully performed with DES implantation. Four months after, CAG was performed again and verified ISR of LCx under diagnosis of recurrent NSTE-ACS. Subsequently multimodality intravascular imaging assessment was performed for the ISR lesion. Optical frequency domain imaging showed the eccentric protruding mass with irregular surface with high-backscatter, whereas angioscopy revealed the in-stent bump with yellow color. The ISR lesion was successfully treated by drug-coated balloon angioplasty. However, he suffered recurrent NSTE-ACS five months later. CAG revealed de novo stenotic lesions not only in re-restenosis of LCx but also in proximal left anterior descending artery and ostium of right coronary artery. He was scheduled to undergo coronary artery bypass grafting for three-vessel disease. Multimodality assessment is useful to diagnose the recurrent restenosis lesion with calcified nodule. <Learning objective: In-stent restenosis (ISR) is rarely recurrent even after drug-eluting stent (DES) implantation. In-stent protruding bump is observed in types of ISR morphology by intravascular imaging, and the finding suggests the possibility of recurrent ISR. Diagnosis of the morphology is sometimes difficult, but multimodality imaging assessment is useful to distinguish the ISR tissue.>
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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: Coronary restenosis of in-stent protruding bump with rapid progression: Optical frequency domain imaging and angioscopic observation ###Abstract: In-stent restenosis (ISR) remains a tough problem after percutaneous coronary intervention (PCI) despite advances in technology of drug-eluting stents (DES). A 63-year-old man undergoing hemodialysis was diagnosed with non-ST elevation acute coronary syndrome (NSTE-ACS). An emergency coronary angiography (CAG) revealed severe stenosis in the middle left circumflex artery (LCx). After pre-dilatation with non-compliant balloon, primary PCI was successfully performed with DES implantation. Four months after, CAG was performed again and verified ISR of LCx under diagnosis of recurrent NSTE-ACS. Subsequently multimodality intravascular imaging assessment was performed for the ISR lesion. Optical frequency domain imaging showed the eccentric protruding mass with irregular surface with high-backscatter, whereas angioscopy revealed the in-stent bump with yellow color. The ISR lesion was successfully treated by drug-coated balloon angioplasty. However, he suffered recurrent NSTE-ACS five months later. CAG revealed de novo stenotic lesions not only in re-restenosis of LCx but also in proximal left anterior descending artery and ostium of right coronary artery. He was scheduled to undergo coronary artery bypass grafting for three-vessel disease. Multimodality assessment is useful to diagnose the recurrent restenosis lesion with calcified nodule. <Learning objective: In-stent restenosis (ISR) is rarely recurrent even after drug-eluting stent (DES) implantation. In-stent protruding bump is observed in types of ISR morphology by intravascular imaging, and the finding suggests the possibility of recurrent ISR. Diagnosis of the morphology is sometimes difficult, but multimodality imaging assessment is useful to distinguish the ISR tissue.> [/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 restenosis of in-stent protruding bump with rapid progression: Optical frequency domain imaging and angioscopic observation ###Abstract: In-stent restenosis (ISR) remains a tough problem after percutaneous coronary intervention (PCI) despite advances in technology of drug-eluting stents (DES). A 63-year-old man undergoing hemodialysis was diagnosed with non-ST elevation acute coronary syndrome (NSTE-ACS). An emergency coronary angiography (CAG) revealed severe stenosis in the middle left circumflex artery (LCx). After pre-dilatation with non-compliant balloon, primary PCI was successfully performed with DES implantation. Four months after, CAG was performed again and verified ISR of LCx under diagnosis of recurrent NSTE-ACS. Subsequently multimodality intravascular imaging assessment was performed for the ISR lesion. Optical frequency domain imaging showed the eccentric protruding mass with irregular surface with high-backscatter, whereas angioscopy revealed the in-stent bump with yellow color. The ISR lesion was successfully treated by drug-coated balloon angioplasty. However, he suffered recurrent NSTE-ACS five months later. CAG revealed de novo stenotic lesions not only in re-restenosis of LCx but also in proximal left anterior descending artery and ostium of right coronary artery. He was scheduled to undergo coronary artery bypass grafting for three-vessel disease. Multimodality assessment is useful to diagnose the recurrent restenosis lesion with calcified nodule. <Learning objective: In-stent restenosis (ISR) is rarely recurrent even after drug-eluting stent (DES) implantation. In-stent protruding bump is observed in types of ISR morphology by intravascular imaging, and the finding suggests the possibility of recurrent ISR. Diagnosis of the morphology is sometimes difficult, but multimodality imaging assessment is useful to distinguish the ISR tissue.> [/INST] Exclude </s>
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Kayssi 2016
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Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs
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Background: Atherosclerotic peripheral arterial disease (PAD) can lead to disabling ischemia and limb loss. Treatment modalities have included risk factor optimization through life-style modifications and medications, or operative approaches using both open and minimally invasive techniques, such as balloon angioplasty. Drug-eluting balloon (DEB) angioplasty has emerged as a promising alternative to uncoated balloon angioplasty for the treatment of this difficult disease process. By ballooning and coating the inside of atherosclerotic vessels with cytotoxic agents, such as paclitaxel, cellular mechanisms responsible for atherosclerosis and neointimal hyperplasia are inhibited and its devastating complications are prevented or postponed. DEBs are considerably more expensive than uncoated balloons, and their efficacy in improving patient outcomes is unclear. Objectives: To assess the efficacy of drug-eluting balloons (DEBs) compared with uncoated, nonstenting balloon angioplasty in people with symptomatic lower-limb peripheral arterial disease (PAD). Search methods: The Cochrane Vascular Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched December 2015) and Cochrane Register of Studies (CRS) (2015, Issue 11). The TSC searched trial databases for details of ongoing and unpublished studies. Selection criteria: We included all randomized controlled trials that compared DEBs with uncoated, nonstenting balloon angioplasty for intermittent claudication (IC) or critical limb ischemia (CLI). Data collection and analysis: Two review authors (AK, TA) independently selected the appropriate trials and performed data extraction, assessment of trial quality, and data analysis. The senior review author (DKR) adjudicated any disagreements. Main results: Eleven trials that randomized 1838 participants met the study inclusion criteria. Seven of the trials included femoropopliteal arterial lesions, three included tibial arterial lesions, and one included both. The trials were carried out in Europe and in the USA and all used the taxane drug paclitaxel in the DEB arm. Nine of the 11 trials were industry-sponsored. Four companies manufactured the DEB devices (Bard, Bavaria Medizin, Biotronik, and Medtronic). The trials examined both anatomic and clinical endpoints. There was heterogeneity in the frequency of stent deployment and the type and duration of antiplatelet therapy between trials. Using GRADE assessment criteria, the quality of the evidence presented was moderate for the outcomes of target lesion revascularization and change in Rutherford category, and high for amputation, primary vessel patency, binary restenosis, death, and change in ankle-brachial index (ABI). Most participants were followed up for 12 months, but one trial reported outcomes at five years. There were better outcomes for DEBs for up to two years in primary vessel patency (odds ratio (OR) 1.47, 95% confidence interval (CI) 0.22 to 9.57 at six months; OR 1.92, 95% CI 1.45 to 2.56 at 12 months; OR 3.51, 95% CI 2.26 to 5.46 at two years) and at six months and two years for late lumen loss (mean difference (MD) -0.64 mm, 95% CI -1.00 to -0.28 at six months; MD -0.80 mm, 95% CI -1.44 to -0.16 at two years). DEB were also superior to uncoated balloon angioplasty for up to five years in target lesion revascularization (OR 0.28, 95% CI 0.17 to 0.47 at six months; OR 0.40, 95% CI 0.31 to 0.51 at 12 months; OR 0.28, 95% CI 0.18 to 0.44 at two years; OR 0.21, 95% CI 0.09 to 0.51 at five years) and binary restenosis rate (OR 0.44, 95% CI 0.29 to 0.67 at six months; OR 0.38, 95% CI 0.15 to 0.98 at 12 months; OR 0.26, 95% CI 0.10 to 0.66 at two years; OR 0.12, 95% CI 0.05 to 0.30 at five years). There was no significant difference between DEB and uncoated angioplasty in amputation, death, change in ABI, change in Rutherford category and quality of life (QoL) scores, or functional walking ability, although none of the trials were powered to detect a significant difference in these clinical endpoints. We carried out two subgroup analyses to examine outcomes in femoropopliteal and tibial interventions as well as in people with CLI (4 or greater Rutherford class), and showed no advantage for DEBs in tibial vessels at six and 12 months compared with uncoated balloon angioplasty. There was also no advantage for DEBs in CLI compared with uncoated balloon angioplasty at 12 months. Authors' conclusions: Based on a meta-analysis of 11 trials with 1838 participants, there is evidence of an advantage for DEBs compared with uncoated balloon angioplasty in several anatomic endpoints such as primary vessel patency (high-quality evidence), binary restenosis rate (moderate-quality evidence), and target lesion revascularization (low-quality evidence) for up to 12 months. Conversely, there is no evidence of an advantage for DEBs in clinical endpoints such as amputation, death, or change in ABI, or change in Rutherford category during 12 months' follow-up. Well-designed randomized trials with long-term follow-up are needed to compare DEBs with uncoated balloon angioplasties adequately for both anatomic and clinical study endpoints before the widespread use of this expensive technology can be justified.
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Exclude
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DE7 - Device not mentioned
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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 angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs ###Abstract: Background: Atherosclerotic peripheral arterial disease (PAD) can lead to disabling ischemia and limb loss. Treatment modalities have included risk factor optimization through life-style modifications and medications, or operative approaches using both open and minimally invasive techniques, such as balloon angioplasty. Drug-eluting balloon (DEB) angioplasty has emerged as a promising alternative to uncoated balloon angioplasty for the treatment of this difficult disease process. By ballooning and coating the inside of atherosclerotic vessels with cytotoxic agents, such as paclitaxel, cellular mechanisms responsible for atherosclerosis and neointimal hyperplasia are inhibited and its devastating complications are prevented or postponed. DEBs are considerably more expensive than uncoated balloons, and their efficacy in improving patient outcomes is unclear. Objectives: To assess the efficacy of drug-eluting balloons (DEBs) compared with uncoated, nonstenting balloon angioplasty in people with symptomatic lower-limb peripheral arterial disease (PAD). Search methods: The Cochrane Vascular Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched December 2015) and Cochrane Register of Studies (CRS) (2015, Issue 11). The TSC searched trial databases for details of ongoing and unpublished studies. Selection criteria: We included all randomized controlled trials that compared DEBs with uncoated, nonstenting balloon angioplasty for intermittent claudication (IC) or critical limb ischemia (CLI). Data collection and analysis: Two review authors (AK, TA) independently selected the appropriate trials and performed data extraction, assessment of trial quality, and data analysis. The senior review author (DKR) adjudicated any disagreements. Main results: Eleven trials that randomized 1838 participants met the study inclusion criteria. Seven of the trials included femoropopliteal arterial lesions, three included tibial arterial lesions, and one included both. The trials were carried out in Europe and in the USA and all used the taxane drug paclitaxel in the DEB arm. Nine of the 11 trials were industry-sponsored. Four companies manufactured the DEB devices (Bard, Bavaria Medizin, Biotronik, and Medtronic). The trials examined both anatomic and clinical endpoints. There was heterogeneity in the frequency of stent deployment and the type and duration of antiplatelet therapy between trials. Using GRADE assessment criteria, the quality of the evidence presented was moderate for the outcomes of target lesion revascularization and change in Rutherford category, and high for amputation, primary vessel patency, binary restenosis, death, and change in ankle-brachial index (ABI). Most participants were followed up for 12 months, but one trial reported outcomes at five years. There were better outcomes for DEBs for up to two years in primary vessel patency (odds ratio (OR) 1.47, 95% confidence interval (CI) 0.22 to 9.57 at six months; OR 1.92, 95% CI 1.45 to 2.56 at 12 months; OR 3.51, 95% CI 2.26 to 5.46 at two years) and at six months and two years for late lumen loss (mean difference (MD) -0.64 mm, 95% CI -1.00 to -0.28 at six months; MD -0.80 mm, 95% CI -1.44 to -0.16 at two years). DEB were also superior to uncoated balloon angioplasty for up to five years in target lesion revascularization (OR 0.28, 95% CI 0.17 to 0.47 at six months; OR 0.40, 95% CI 0.31 to 0.51 at 12 months; OR 0.28, 95% CI 0.18 to 0.44 at two years; OR 0.21, 95% CI 0.09 to 0.51 at five years) and binary restenosis rate (OR 0.44, 95% CI 0.29 to 0.67 at six months; OR 0.38, 95% CI 0.15 to 0.98 at 12 months; OR 0.26, 95% CI 0.10 to 0.66 at two years; OR 0.12, 95% CI 0.05 to 0.30 at five years). There was no significant difference between DEB and uncoated angioplasty in amputation, death, change in ABI, change in Rutherford category and quality of life (QoL) scores, or functional walking ability, although none of the trials were powered to detect a significant difference in these clinical endpoints. We carried out two subgroup analyses to examine outcomes in femoropopliteal and tibial interventions as well as in people with CLI (4 or greater Rutherford class), and showed no advantage for DEBs in tibial vessels at six and 12 months compared with uncoated balloon angioplasty. There was also no advantage for DEBs in CLI compared with uncoated balloon angioplasty at 12 months. Authors' conclusions: Based on a meta-analysis of 11 trials with 1838 participants, there is evidence of an advantage for DEBs compared with uncoated balloon angioplasty in several anatomic endpoints such as primary vessel patency (high-quality evidence), binary restenosis rate (moderate-quality evidence), and target lesion revascularization (low-quality evidence) for up to 12 months. Conversely, there is no evidence of an advantage for DEBs in clinical endpoints such as amputation, death, or change in ABI, or change in Rutherford category during 12 months' follow-up. Well-designed randomized trials with long-term follow-up are needed to compare DEBs with uncoated balloon angioplasties adequately for both anatomic and clinical study endpoints before the widespread use of this expensive technology can be justified. [/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 angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs ###Abstract: Background: Atherosclerotic peripheral arterial disease (PAD) can lead to disabling ischemia and limb loss. Treatment modalities have included risk factor optimization through life-style modifications and medications, or operative approaches using both open and minimally invasive techniques, such as balloon angioplasty. Drug-eluting balloon (DEB) angioplasty has emerged as a promising alternative to uncoated balloon angioplasty for the treatment of this difficult disease process. By ballooning and coating the inside of atherosclerotic vessels with cytotoxic agents, such as paclitaxel, cellular mechanisms responsible for atherosclerosis and neointimal hyperplasia are inhibited and its devastating complications are prevented or postponed. DEBs are considerably more expensive than uncoated balloons, and their efficacy in improving patient outcomes is unclear. Objectives: To assess the efficacy of drug-eluting balloons (DEBs) compared with uncoated, nonstenting balloon angioplasty in people with symptomatic lower-limb peripheral arterial disease (PAD). Search methods: The Cochrane Vascular Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched December 2015) and Cochrane Register of Studies (CRS) (2015, Issue 11). The TSC searched trial databases for details of ongoing and unpublished studies. Selection criteria: We included all randomized controlled trials that compared DEBs with uncoated, nonstenting balloon angioplasty for intermittent claudication (IC) or critical limb ischemia (CLI). Data collection and analysis: Two review authors (AK, TA) independently selected the appropriate trials and performed data extraction, assessment of trial quality, and data analysis. The senior review author (DKR) adjudicated any disagreements. Main results: Eleven trials that randomized 1838 participants met the study inclusion criteria. Seven of the trials included femoropopliteal arterial lesions, three included tibial arterial lesions, and one included both. The trials were carried out in Europe and in the USA and all used the taxane drug paclitaxel in the DEB arm. Nine of the 11 trials were industry-sponsored. Four companies manufactured the DEB devices (Bard, Bavaria Medizin, Biotronik, and Medtronic). The trials examined both anatomic and clinical endpoints. There was heterogeneity in the frequency of stent deployment and the type and duration of antiplatelet therapy between trials. Using GRADE assessment criteria, the quality of the evidence presented was moderate for the outcomes of target lesion revascularization and change in Rutherford category, and high for amputation, primary vessel patency, binary restenosis, death, and change in ankle-brachial index (ABI). Most participants were followed up for 12 months, but one trial reported outcomes at five years. There were better outcomes for DEBs for up to two years in primary vessel patency (odds ratio (OR) 1.47, 95% confidence interval (CI) 0.22 to 9.57 at six months; OR 1.92, 95% CI 1.45 to 2.56 at 12 months; OR 3.51, 95% CI 2.26 to 5.46 at two years) and at six months and two years for late lumen loss (mean difference (MD) -0.64 mm, 95% CI -1.00 to -0.28 at six months; MD -0.80 mm, 95% CI -1.44 to -0.16 at two years). DEB were also superior to uncoated balloon angioplasty for up to five years in target lesion revascularization (OR 0.28, 95% CI 0.17 to 0.47 at six months; OR 0.40, 95% CI 0.31 to 0.51 at 12 months; OR 0.28, 95% CI 0.18 to 0.44 at two years; OR 0.21, 95% CI 0.09 to 0.51 at five years) and binary restenosis rate (OR 0.44, 95% CI 0.29 to 0.67 at six months; OR 0.38, 95% CI 0.15 to 0.98 at 12 months; OR 0.26, 95% CI 0.10 to 0.66 at two years; OR 0.12, 95% CI 0.05 to 0.30 at five years). There was no significant difference between DEB and uncoated angioplasty in amputation, death, change in ABI, change in Rutherford category and quality of life (QoL) scores, or functional walking ability, although none of the trials were powered to detect a significant difference in these clinical endpoints. We carried out two subgroup analyses to examine outcomes in femoropopliteal and tibial interventions as well as in people with CLI (4 or greater Rutherford class), and showed no advantage for DEBs in tibial vessels at six and 12 months compared with uncoated balloon angioplasty. There was also no advantage for DEBs in CLI compared with uncoated balloon angioplasty at 12 months. Authors' conclusions: Based on a meta-analysis of 11 trials with 1838 participants, there is evidence of an advantage for DEBs compared with uncoated balloon angioplasty in several anatomic endpoints such as primary vessel patency (high-quality evidence), binary restenosis rate (moderate-quality evidence), and target lesion revascularization (low-quality evidence) for up to 12 months. Conversely, there is no evidence of an advantage for DEBs in clinical endpoints such as amputation, death, or change in ABI, or change in Rutherford category during 12 months' follow-up. Well-designed randomized trials with long-term follow-up are needed to compare DEBs with uncoated balloon angioplasties adequately for both anatomic and clinical study endpoints before the widespread use of this expensive technology can be justified. [/INST] Exclude </s>
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Kayssi 2019
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Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for the treatment of in-stent restenosis of the femoropopliteal arteries
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Background: Stents are placed in the femoropopliteal arteries for numerous reasons, such as atherosclerotic disease, the need for dissection, and perforation of the arteries, and can become stenosed with the passage of time. When a stent develops a flow-limiting stenosis, this process is known as "in-stent stenosis." It is thought that in-stent restenosis is caused by a process known as "intimal hyperplasia" rather than by the progression of atherosclerotic disease. Management of in-stent restenosis may include performing balloon angioplasty, deploying another stent within the stenosed stent to force it open, and creating a bypass to deliver blood around the stent. The role of drug-eluting technologies, such as drug-eluting balloons (DEBs), in the management of in-stent restenosis is unclear. Drug-eluting balloons might function by coating the inside of stenosed stents with cytotoxic chemicals such as paclitaxel and by inhibiting the hyperplastic processes responsible for in-stent restenosis. It is important to perform this systematic review to evaluate the efficacy of DEB because of the potential for increased expenses associated with DEBs over uncoated balloon angioplasty, also known as plain old balloon angioplasty (POBA). Objectives: To assess the safety and efficacy of DEBs compared with uncoated balloon angioplasty in people with in-stent restenosis of the femoropopliteal arteries as assessed by criteria such as amputation-free survival, vessel patency, target lesion revascularization, binary restenosis rate, and death. We define "in-stent restenosis" as 50% or greater narrowing of a previously stented vessel by duplex ultrasound or angiography. Search methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to November 28, 2017. Review authors also undertook reference checking to identify additional studies. Selection criteria: We included all randomized controlled trials that compared DEBs versus uncoated balloon angioplasty for treatment of in-stent restenosis in the femoropopliteal arteries. Data collection and analysis: Two review authors (AK, WA) independently selected appropriate trials and performed data extraction, assessment of trial quality, and data analysis. The senior review author (AD) adjudicated any disagreements. Main results: Three trials that randomized a combined total of 263 participants met the review inclusion criteria. All three trials examined the treatment of symptomatic in-stent restenosis within the femoropopliteal arteries. These trials were carried out in Germany and Austria and used paclitaxel as the agent in the drug-eluting balloons. Two of the three trials were industry sponsored. Two companies manufactured the drug-eluting balloons (Eurocor, Bonn, Germany; Medtronic, Fridley, Minnesota, USA). The trials examined both anatomical and clinical endpoints. We noted heterogeneity in the frequency of bailout stenting deployment between studies as well as in the dosage of paclitaxel applied by the DEBs. Using GRADE assessment criteria, we determined that the certainty of evidence presented was very low for the outcomes of amputation, target lesion revascularization, binary restenosis, death, and improvement of one or more Rutherford categories. Most participants were followed up to 12 months, but one trial followed participants for up to 24 months. Trial results show no difference in the incidence of amputation between DEBs and uncoated balloon angioplasty. DEBs showed better outcomes for up to 24 months for target lesion revascularization (odds ratio (OR) 0.05, 95% confidence Interval (CI) 0.00 to 0.92 at six months; OR 0.24, 95% CI 0.08 to 0.70 at 24 months) and at six and 12 months for binary restenosis (OR 0.28, 95% CI 0.14 to 0.56 at six months; OR 0.34, 95% CI 0.15 to 0.76 at 12 months). Participants treated with DEBs also showed improvement of one or more Rutherford categories at six and 12 months (OR 1.81, 95% CI 1.02 to 3.21 at six months; OR 2.08, 95% CI 1.13 to 3.83 at 12 months). Data show no clear differences in death between DEBs and uncoated balloon angioplasty. Data were insufficient for subgroup or sensitivity analyses to be conducted. Authors' conclusions: Based on a meta-analysis of three trials with 263 participants, evidence suggests an advantage for DEBs compared with uncoated balloon angioplasty for anatomical endpoints such as target lesion revascularization (TLR) and binary restenosis, and for one clinical endpoint - improvement in Rutherford category post intervention for up to 24 months. However, the certainty of evidence for all these outcomes is very low due to the small number of included studies and participants and the high risk of bias in study design. Adequately powered and carefully constructed randomized controlled trials are needed to adequately investigate the role of drug-eluting technologies in the management of in-stent restenosis.
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Exclude
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DE7 - Device not mentioned
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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 angioplasty versus uncoated balloon angioplasty for the treatment of in-stent restenosis of the femoropopliteal arteries ###Abstract: Background: Stents are placed in the femoropopliteal arteries for numerous reasons, such as atherosclerotic disease, the need for dissection, and perforation of the arteries, and can become stenosed with the passage of time. When a stent develops a flow-limiting stenosis, this process is known as "in-stent stenosis." It is thought that in-stent restenosis is caused by a process known as "intimal hyperplasia" rather than by the progression of atherosclerotic disease. Management of in-stent restenosis may include performing balloon angioplasty, deploying another stent within the stenosed stent to force it open, and creating a bypass to deliver blood around the stent. The role of drug-eluting technologies, such as drug-eluting balloons (DEBs), in the management of in-stent restenosis is unclear. Drug-eluting balloons might function by coating the inside of stenosed stents with cytotoxic chemicals such as paclitaxel and by inhibiting the hyperplastic processes responsible for in-stent restenosis. It is important to perform this systematic review to evaluate the efficacy of DEB because of the potential for increased expenses associated with DEBs over uncoated balloon angioplasty, also known as plain old balloon angioplasty (POBA). Objectives: To assess the safety and efficacy of DEBs compared with uncoated balloon angioplasty in people with in-stent restenosis of the femoropopliteal arteries as assessed by criteria such as amputation-free survival, vessel patency, target lesion revascularization, binary restenosis rate, and death. We define "in-stent restenosis" as 50% or greater narrowing of a previously stented vessel by duplex ultrasound or angiography. Search methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to November 28, 2017. Review authors also undertook reference checking to identify additional studies. Selection criteria: We included all randomized controlled trials that compared DEBs versus uncoated balloon angioplasty for treatment of in-stent restenosis in the femoropopliteal arteries. Data collection and analysis: Two review authors (AK, WA) independently selected appropriate trials and performed data extraction, assessment of trial quality, and data analysis. The senior review author (AD) adjudicated any disagreements. Main results: Three trials that randomized a combined total of 263 participants met the review inclusion criteria. All three trials examined the treatment of symptomatic in-stent restenosis within the femoropopliteal arteries. These trials were carried out in Germany and Austria and used paclitaxel as the agent in the drug-eluting balloons. Two of the three trials were industry sponsored. Two companies manufactured the drug-eluting balloons (Eurocor, Bonn, Germany; Medtronic, Fridley, Minnesota, USA). The trials examined both anatomical and clinical endpoints. We noted heterogeneity in the frequency of bailout stenting deployment between studies as well as in the dosage of paclitaxel applied by the DEBs. Using GRADE assessment criteria, we determined that the certainty of evidence presented was very low for the outcomes of amputation, target lesion revascularization, binary restenosis, death, and improvement of one or more Rutherford categories. Most participants were followed up to 12 months, but one trial followed participants for up to 24 months. Trial results show no difference in the incidence of amputation between DEBs and uncoated balloon angioplasty. DEBs showed better outcomes for up to 24 months for target lesion revascularization (odds ratio (OR) 0.05, 95% confidence Interval (CI) 0.00 to 0.92 at six months; OR 0.24, 95% CI 0.08 to 0.70 at 24 months) and at six and 12 months for binary restenosis (OR 0.28, 95% CI 0.14 to 0.56 at six months; OR 0.34, 95% CI 0.15 to 0.76 at 12 months). Participants treated with DEBs also showed improvement of one or more Rutherford categories at six and 12 months (OR 1.81, 95% CI 1.02 to 3.21 at six months; OR 2.08, 95% CI 1.13 to 3.83 at 12 months). Data show no clear differences in death between DEBs and uncoated balloon angioplasty. Data were insufficient for subgroup or sensitivity analyses to be conducted. Authors' conclusions: Based on a meta-analysis of three trials with 263 participants, evidence suggests an advantage for DEBs compared with uncoated balloon angioplasty for anatomical endpoints such as target lesion revascularization (TLR) and binary restenosis, and for one clinical endpoint - improvement in Rutherford category post intervention for up to 24 months. However, the certainty of evidence for all these outcomes is very low due to the small number of included studies and participants and the high risk of bias in study design. Adequately powered and carefully constructed randomized controlled trials are needed to adequately investigate the role of drug-eluting technologies in the management of in-stent restenosis. [/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 angioplasty versus uncoated balloon angioplasty for the treatment of in-stent restenosis of the femoropopliteal arteries ###Abstract: Background: Stents are placed in the femoropopliteal arteries for numerous reasons, such as atherosclerotic disease, the need for dissection, and perforation of the arteries, and can become stenosed with the passage of time. When a stent develops a flow-limiting stenosis, this process is known as "in-stent stenosis." It is thought that in-stent restenosis is caused by a process known as "intimal hyperplasia" rather than by the progression of atherosclerotic disease. Management of in-stent restenosis may include performing balloon angioplasty, deploying another stent within the stenosed stent to force it open, and creating a bypass to deliver blood around the stent. The role of drug-eluting technologies, such as drug-eluting balloons (DEBs), in the management of in-stent restenosis is unclear. Drug-eluting balloons might function by coating the inside of stenosed stents with cytotoxic chemicals such as paclitaxel and by inhibiting the hyperplastic processes responsible for in-stent restenosis. It is important to perform this systematic review to evaluate the efficacy of DEB because of the potential for increased expenses associated with DEBs over uncoated balloon angioplasty, also known as plain old balloon angioplasty (POBA). Objectives: To assess the safety and efficacy of DEBs compared with uncoated balloon angioplasty in people with in-stent restenosis of the femoropopliteal arteries as assessed by criteria such as amputation-free survival, vessel patency, target lesion revascularization, binary restenosis rate, and death. We define "in-stent restenosis" as 50% or greater narrowing of a previously stented vessel by duplex ultrasound or angiography. Search methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to November 28, 2017. Review authors also undertook reference checking to identify additional studies. Selection criteria: We included all randomized controlled trials that compared DEBs versus uncoated balloon angioplasty for treatment of in-stent restenosis in the femoropopliteal arteries. Data collection and analysis: Two review authors (AK, WA) independently selected appropriate trials and performed data extraction, assessment of trial quality, and data analysis. The senior review author (AD) adjudicated any disagreements. Main results: Three trials that randomized a combined total of 263 participants met the review inclusion criteria. All three trials examined the treatment of symptomatic in-stent restenosis within the femoropopliteal arteries. These trials were carried out in Germany and Austria and used paclitaxel as the agent in the drug-eluting balloons. Two of the three trials were industry sponsored. Two companies manufactured the drug-eluting balloons (Eurocor, Bonn, Germany; Medtronic, Fridley, Minnesota, USA). The trials examined both anatomical and clinical endpoints. We noted heterogeneity in the frequency of bailout stenting deployment between studies as well as in the dosage of paclitaxel applied by the DEBs. Using GRADE assessment criteria, we determined that the certainty of evidence presented was very low for the outcomes of amputation, target lesion revascularization, binary restenosis, death, and improvement of one or more Rutherford categories. Most participants were followed up to 12 months, but one trial followed participants for up to 24 months. Trial results show no difference in the incidence of amputation between DEBs and uncoated balloon angioplasty. DEBs showed better outcomes for up to 24 months for target lesion revascularization (odds ratio (OR) 0.05, 95% confidence Interval (CI) 0.00 to 0.92 at six months; OR 0.24, 95% CI 0.08 to 0.70 at 24 months) and at six and 12 months for binary restenosis (OR 0.28, 95% CI 0.14 to 0.56 at six months; OR 0.34, 95% CI 0.15 to 0.76 at 12 months). Participants treated with DEBs also showed improvement of one or more Rutherford categories at six and 12 months (OR 1.81, 95% CI 1.02 to 3.21 at six months; OR 2.08, 95% CI 1.13 to 3.83 at 12 months). Data show no clear differences in death between DEBs and uncoated balloon angioplasty. Data were insufficient for subgroup or sensitivity analyses to be conducted. Authors' conclusions: Based on a meta-analysis of three trials with 263 participants, evidence suggests an advantage for DEBs compared with uncoated balloon angioplasty for anatomical endpoints such as target lesion revascularization (TLR) and binary restenosis, and for one clinical endpoint - improvement in Rutherford category post intervention for up to 24 months. However, the certainty of evidence for all these outcomes is very low due to the small number of included studies and participants and the high risk of bias in study design. Adequately powered and carefully constructed randomized controlled trials are needed to adequately investigate the role of drug-eluting technologies in the management of in-stent restenosis. [/INST] Exclude </s>
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Klein 2017
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SCAI appropriate use criteria for peripheral arterial interventions: An update
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Exclude
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DE8 - Guidance
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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: SCAI appropriate use criteria for peripheral arterial interventions: An update ###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: SCAI appropriate use criteria for peripheral arterial interventions: An update ###Abstract: None [/INST] Exclude </s>
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Kokkinidis 2018b
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Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry
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With growing use of drug-coated balloons (DCB) for femoropopliteal (FP) artery interventions, there is limited information on rates of real-world adjunctive stent use and its association with short and long-term outcomes. We report on 225 DCB treated FP lesions in 224 patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) between 2014 and 2016. Cochran–Mantel–Haenszel and Wilcoxon rank sum statistics were used to compare stented (planned or ‘bail-out’) versus non-stented DCB treated lesions. Stents were implanted in 31% of FP DCB interventions. Among the 70 stents implanted, 46% were for ‘bail-out’ indications and 54% were planned. Lesions treated with stents were longer (mean 150 mm vs 100 mm; p < 0.001) and less likely to be in-stent restenosis lesions (10% vs 28%; p=0.003). Stenting was significantly more frequent in complex FP lesions, including chronic total occlusions (66% vs 34%; p < 0.001). For bail-out stenting, interwoven nitinol stents were the most common type (50%) followed by drug-eluting stents (34%) and bare-metal stents (22%). There were no differences in peri-procedural complication rates or 12-month target limb revascularization rates (18.6% vs 11.6%; p=0.162) or 12-month amputation rates (11.4% vs 11%; p=0.92) between lesions where adjunctive stenting was used versus lesions without adjunctive stenting, respectively. In conclusion, in a contemporary ‘real-world’ adjudicated multicenter US registry, adjunctive stenting was necessary in nearly a third of the lesions, primarily for the treatment of more complex FP lesions, with similar short and intermediate-term clinical outcomes compared with non-stented lesions. ClinicalTrials.gov Identifier: NCT01904851.
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Exclude
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DE7 - Device not mentioned
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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: Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry ###Abstract: With growing use of drug-coated balloons (DCB) for femoropopliteal (FP) artery interventions, there is limited information on rates of real-world adjunctive stent use and its association with short and long-term outcomes. We report on 225 DCB treated FP lesions in 224 patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) between 2014 and 2016. Cochran–Mantel–Haenszel and Wilcoxon rank sum statistics were used to compare stented (planned or ‘bail-out’) versus non-stented DCB treated lesions. Stents were implanted in 31% of FP DCB interventions. Among the 70 stents implanted, 46% were for ‘bail-out’ indications and 54% were planned. Lesions treated with stents were longer (mean 150 mm vs 100 mm; p < 0.001) and less likely to be in-stent restenosis lesions (10% vs 28%; p=0.003). Stenting was significantly more frequent in complex FP lesions, including chronic total occlusions (66% vs 34%; p < 0.001). For bail-out stenting, interwoven nitinol stents were the most common type (50%) followed by drug-eluting stents (34%) and bare-metal stents (22%). There were no differences in peri-procedural complication rates or 12-month target limb revascularization rates (18.6% vs 11.6%; p=0.162) or 12-month amputation rates (11.4% vs 11%; p=0.92) between lesions where adjunctive stenting was used versus lesions without adjunctive stenting, respectively. In conclusion, in a contemporary ‘real-world’ adjudicated multicenter US registry, adjunctive stenting was necessary in nearly a third of the lesions, primarily for the treatment of more complex FP lesions, with similar short and intermediate-term clinical outcomes compared with non-stented lesions. ClinicalTrials.gov Identifier: NCT01904851. [/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: Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry ###Abstract: With growing use of drug-coated balloons (DCB) for femoropopliteal (FP) artery interventions, there is limited information on rates of real-world adjunctive stent use and its association with short and long-term outcomes. We report on 225 DCB treated FP lesions in 224 patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) between 2014 and 2016. Cochran–Mantel–Haenszel and Wilcoxon rank sum statistics were used to compare stented (planned or ‘bail-out’) versus non-stented DCB treated lesions. Stents were implanted in 31% of FP DCB interventions. Among the 70 stents implanted, 46% were for ‘bail-out’ indications and 54% were planned. Lesions treated with stents were longer (mean 150 mm vs 100 mm; p < 0.001) and less likely to be in-stent restenosis lesions (10% vs 28%; p=0.003). Stenting was significantly more frequent in complex FP lesions, including chronic total occlusions (66% vs 34%; p < 0.001). For bail-out stenting, interwoven nitinol stents were the most common type (50%) followed by drug-eluting stents (34%) and bare-metal stents (22%). There were no differences in peri-procedural complication rates or 12-month target limb revascularization rates (18.6% vs 11.6%; p=0.162) or 12-month amputation rates (11.4% vs 11%; p=0.92) between lesions where adjunctive stenting was used versus lesions without adjunctive stenting, respectively. In conclusion, in a contemporary ‘real-world’ adjudicated multicenter US registry, adjunctive stenting was necessary in nearly a third of the lesions, primarily for the treatment of more complex FP lesions, with similar short and intermediate-term clinical outcomes compared with non-stented lesions. ClinicalTrials.gov Identifier: NCT01904851. [/INST] Exclude </s>
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Kolli 2016
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Interventional Management of Vascular Renal Transplant Complications
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Renal transplantation is the therapy of choice in patients with end stage renal disease. Although transplant rejection remains the most common complication after renal transplantation, vascular anatomical complications occur in 1%-23% of renal transplant recipients. Interventional radiologists play an important role in the management of these complications. This review discusses the role of image-guided interventions within the context of multidisciplinary patient management. Particular emphasis is given to anatomical considerations unique to this patient population, techniques used for image-guided interventions, and outcomes of image-guided interventions.
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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: Interventional Management of Vascular Renal Transplant Complications ###Abstract: Renal transplantation is the therapy of choice in patients with end stage renal disease. Although transplant rejection remains the most common complication after renal transplantation, vascular anatomical complications occur in 1%-23% of renal transplant recipients. Interventional radiologists play an important role in the management of these complications. This review discusses the role of image-guided interventions within the context of multidisciplinary patient management. Particular emphasis is given to anatomical considerations unique to this patient population, techniques used for image-guided interventions, and outcomes of image-guided interventions. [/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: Interventional Management of Vascular Renal Transplant Complications ###Abstract: Renal transplantation is the therapy of choice in patients with end stage renal disease. Although transplant rejection remains the most common complication after renal transplantation, vascular anatomical complications occur in 1%-23% of renal transplant recipients. Interventional radiologists play an important role in the management of these complications. This review discusses the role of image-guided interventions within the context of multidisciplinary patient management. Particular emphasis is given to anatomical considerations unique to this patient population, techniques used for image-guided interventions, and outcomes of image-guided interventions. [/INST] Exclude </s>
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Korosoglou 2017
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Successful recanalization of long femoro-crural occlusive disease after failed bypass surgery
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Patients with critical limb ischemia necessitate immediate intervention to restore blood flow to the affected limb. Endovascular procedures are currently preferred for these patients. We describe the case of an 80-year-old female patient who presented to our department with ischemic rest pain and ulceration of the left limb. The patient had history of left femoral popliteal bypass surgery, femoral thromboendarterectomy and patch angioplasty of the same limb 2 years ago. Doppler sonography and magnetic resonance angiography revealed an occlusion of the left superficial femoral artery (SFA) and popliteal artery and of all three infra-popliteal arteries. Due to severe comorbidities, the patient was scheduled for a digital subtraction angiography. An antegrade approach was first attempted, however the occlusion could not be passed. After revision of the angiography acquisition, a stent was identified at the level of the mid SFA, which was subsequently directly punctured, facilitating the retrograde crossing of the occlusion. Thereafter, balloon angioplasty was performed in the SFA, popliteal artery and posterior tibial artery. The result was considered suboptimal, but due to the large amount of contrast agent used, a second angiography was planned in 4 wk. In the second session, drug coated balloons were used to optimize treatment of the SFA, combined with recanalization of the left fibular artery, to optimize outflow. The post-procedural course was uneventful. Ischemic pain resolved completely after the procedure and at 8 wk of follow-up and the foot ulceration completely healed.
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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: Successful recanalization of long femoro-crural occlusive disease after failed bypass surgery ###Abstract: Patients with critical limb ischemia necessitate immediate intervention to restore blood flow to the affected limb. Endovascular procedures are currently preferred for these patients. We describe the case of an 80-year-old female patient who presented to our department with ischemic rest pain and ulceration of the left limb. The patient had history of left femoral popliteal bypass surgery, femoral thromboendarterectomy and patch angioplasty of the same limb 2 years ago. Doppler sonography and magnetic resonance angiography revealed an occlusion of the left superficial femoral artery (SFA) and popliteal artery and of all three infra-popliteal arteries. Due to severe comorbidities, the patient was scheduled for a digital subtraction angiography. An antegrade approach was first attempted, however the occlusion could not be passed. After revision of the angiography acquisition, a stent was identified at the level of the mid SFA, which was subsequently directly punctured, facilitating the retrograde crossing of the occlusion. Thereafter, balloon angioplasty was performed in the SFA, popliteal artery and posterior tibial artery. The result was considered suboptimal, but due to the large amount of contrast agent used, a second angiography was planned in 4 wk. In the second session, drug coated balloons were used to optimize treatment of the SFA, combined with recanalization of the left fibular artery, to optimize outflow. The post-procedural course was uneventful. Ischemic pain resolved completely after the procedure and at 8 wk of follow-up and the foot ulceration completely healed. [/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 recanalization of long femoro-crural occlusive disease after failed bypass surgery ###Abstract: Patients with critical limb ischemia necessitate immediate intervention to restore blood flow to the affected limb. Endovascular procedures are currently preferred for these patients. We describe the case of an 80-year-old female patient who presented to our department with ischemic rest pain and ulceration of the left limb. The patient had history of left femoral popliteal bypass surgery, femoral thromboendarterectomy and patch angioplasty of the same limb 2 years ago. Doppler sonography and magnetic resonance angiography revealed an occlusion of the left superficial femoral artery (SFA) and popliteal artery and of all three infra-popliteal arteries. Due to severe comorbidities, the patient was scheduled for a digital subtraction angiography. An antegrade approach was first attempted, however the occlusion could not be passed. After revision of the angiography acquisition, a stent was identified at the level of the mid SFA, which was subsequently directly punctured, facilitating the retrograde crossing of the occlusion. Thereafter, balloon angioplasty was performed in the SFA, popliteal artery and posterior tibial artery. The result was considered suboptimal, but due to the large amount of contrast agent used, a second angiography was planned in 4 wk. In the second session, drug coated balloons were used to optimize treatment of the SFA, combined with recanalization of the left fibular artery, to optimize outflow. The post-procedural course was uneventful. Ischemic pain resolved completely after the procedure and at 8 wk of follow-up and the foot ulceration completely healed. [/INST] Exclude </s>
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Langhoff 2016
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Promising role of drug-coated balloons in the tibial vessels?
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In order to assess the role of drug-coated balloons (DCB) in below-the-knee (BTK) artery interventions, we analyzed randomized trials which compare coated to non-coated balloons and additionally a direct comparison of drug-eluting stents (DES) with DCB. As angioplasty with noncoated balloons is per guideline-recommendation still standard of care for below-the-knee artery endovascular treatment, we focused on the direct comparison of efficacy and clinical outcome data of both treatment modalities. Data from peer reviewed and published trials were consulted. For each single study, primary and secondary endpoints were reported and compared. Three single-center, non-core lab adjudicated trials showed encouraging data which suggests that DCB in BTK arteries effectively inhibit the risk of early restenosis, but the pivotal, prospectively randomized, multicenter, core lab adjudicated trials failed to match with these result. Limitations of DEB treatment and trials in BTK arteries had been reported, hence a technical evaluation of possible side effects of DCB treatment and of trial design was taken into account. On the basis of the results available, the distinguishing findings of drug eluting effects in the femoropopliteal region cannot be transferred to BTK arteries. Refinement of the existing DCB technology and of future trial design should be considered. To adjudicate on DCB technology applied for BTK treatment is premature and it is mandatory to be kept under evaluation, because the potential benefit, with respect to the compelling results in the femoropoliteal arteries, could be huge to improve endovascular BTK and especially CLI treatment.
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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: Promising role of drug-coated balloons in the tibial vessels? ###Abstract: In order to assess the role of drug-coated balloons (DCB) in below-the-knee (BTK) artery interventions, we analyzed randomized trials which compare coated to non-coated balloons and additionally a direct comparison of drug-eluting stents (DES) with DCB. As angioplasty with noncoated balloons is per guideline-recommendation still standard of care for below-the-knee artery endovascular treatment, we focused on the direct comparison of efficacy and clinical outcome data of both treatment modalities. Data from peer reviewed and published trials were consulted. For each single study, primary and secondary endpoints were reported and compared. Three single-center, non-core lab adjudicated trials showed encouraging data which suggests that DCB in BTK arteries effectively inhibit the risk of early restenosis, but the pivotal, prospectively randomized, multicenter, core lab adjudicated trials failed to match with these result. Limitations of DEB treatment and trials in BTK arteries had been reported, hence a technical evaluation of possible side effects of DCB treatment and of trial design was taken into account. On the basis of the results available, the distinguishing findings of drug eluting effects in the femoropopliteal region cannot be transferred to BTK arteries. Refinement of the existing DCB technology and of future trial design should be considered. To adjudicate on DCB technology applied for BTK treatment is premature and it is mandatory to be kept under evaluation, because the potential benefit, with respect to the compelling results in the femoropoliteal arteries, could be huge to improve endovascular BTK and especially CLI 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: Promising role of drug-coated balloons in the tibial vessels? ###Abstract: In order to assess the role of drug-coated balloons (DCB) in below-the-knee (BTK) artery interventions, we analyzed randomized trials which compare coated to non-coated balloons and additionally a direct comparison of drug-eluting stents (DES) with DCB. As angioplasty with noncoated balloons is per guideline-recommendation still standard of care for below-the-knee artery endovascular treatment, we focused on the direct comparison of efficacy and clinical outcome data of both treatment modalities. Data from peer reviewed and published trials were consulted. For each single study, primary and secondary endpoints were reported and compared. Three single-center, non-core lab adjudicated trials showed encouraging data which suggests that DCB in BTK arteries effectively inhibit the risk of early restenosis, but the pivotal, prospectively randomized, multicenter, core lab adjudicated trials failed to match with these result. Limitations of DEB treatment and trials in BTK arteries had been reported, hence a technical evaluation of possible side effects of DCB treatment and of trial design was taken into account. On the basis of the results available, the distinguishing findings of drug eluting effects in the femoropopliteal region cannot be transferred to BTK arteries. Refinement of the existing DCB technology and of future trial design should be considered. To adjudicate on DCB technology applied for BTK treatment is premature and it is mandatory to be kept under evaluation, because the potential benefit, with respect to the compelling results in the femoropoliteal arteries, could be huge to improve endovascular BTK and especially CLI treatment. [/INST] Exclude </s>
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Laparra 2019
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Successful treatment of a superficial femoral artery pseudoaneurysm with balloon tamponade
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The development of post-catheterization arterial pseudoaneurysms is one of the most common vascular access complications following angiographies and endovascular interventions. Different therapeutic options to treat these lesions have been used. We herein report the case of a 79-year-old woman who was referred to our service for evaluation with a post-catheterization superficial femoral artery pseudoaneurysm measuring 4 cm. Owing to the anatomical location of the arterial pseudoaneurysm and the patient’s refusal to undergo open surgery, we treated the lesion using an endovascular approach with a balloon tamponade. The procedure was successful, and the patient recovered well and was discharged from the hospital without complications. At 6-month follow-up she remained symptom-free and without recurrence.
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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: Successful treatment of a superficial femoral artery pseudoaneurysm with balloon tamponade ###Abstract: The development of post-catheterization arterial pseudoaneurysms is one of the most common vascular access complications following angiographies and endovascular interventions. Different therapeutic options to treat these lesions have been used. We herein report the case of a 79-year-old woman who was referred to our service for evaluation with a post-catheterization superficial femoral artery pseudoaneurysm measuring 4 cm. Owing to the anatomical location of the arterial pseudoaneurysm and the patient’s refusal to undergo open surgery, we treated the lesion using an endovascular approach with a balloon tamponade. The procedure was successful, and the patient recovered well and was discharged from the hospital without complications. At 6-month follow-up she remained symptom-free and without recurrence. [/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 treatment of a superficial femoral artery pseudoaneurysm with balloon tamponade ###Abstract: The development of post-catheterization arterial pseudoaneurysms is one of the most common vascular access complications following angiographies and endovascular interventions. Different therapeutic options to treat these lesions have been used. We herein report the case of a 79-year-old woman who was referred to our service for evaluation with a post-catheterization superficial femoral artery pseudoaneurysm measuring 4 cm. Owing to the anatomical location of the arterial pseudoaneurysm and the patient’s refusal to undergo open surgery, we treated the lesion using an endovascular approach with a balloon tamponade. The procedure was successful, and the patient recovered well and was discharged from the hospital without complications. At 6-month follow-up she remained symptom-free and without recurrence. [/INST] Exclude </s>
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Laricchia 2019
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Peri-Procedural Acute Coronary Syndrome During Transcatheter Aortic Valve Replacement
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A 76-year-old male with severe chronic kidney disease, porcelain aorta and an oral squamous cell carcinoma (scheduled for chemotherapy and surgical excision) underwent transfemoral aortic valve replacement (TAVR) with a CoreValve Evolut R 34 due to severe aortic stenosis. The percutaneous treatment of a severely calcified stable lesion on ostial left circumflex (LCx) artery was not considered a priority due to the patient's comorbidities and the concerns about dual antiplatelet therapy. However, shortly afterwards valve deployment the patient developed an acute myocardial ischemia on the lateral wall due to LCx artery lesion becoming unstable; it was successfully treated with urgent coronary angioplasty and drug eluting stent implantation. A combination of multiple precipitating factors could be involved in the development of acute coronary syndrome during TAVR procedures.
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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: Peri-Procedural Acute Coronary Syndrome During Transcatheter Aortic Valve Replacement ###Abstract: A 76-year-old male with severe chronic kidney disease, porcelain aorta and an oral squamous cell carcinoma (scheduled for chemotherapy and surgical excision) underwent transfemoral aortic valve replacement (TAVR) with a CoreValve Evolut R 34 due to severe aortic stenosis. The percutaneous treatment of a severely calcified stable lesion on ostial left circumflex (LCx) artery was not considered a priority due to the patient's comorbidities and the concerns about dual antiplatelet therapy. However, shortly afterwards valve deployment the patient developed an acute myocardial ischemia on the lateral wall due to LCx artery lesion becoming unstable; it was successfully treated with urgent coronary angioplasty and drug eluting stent implantation. A combination of multiple precipitating factors could be involved in the development of acute coronary syndrome during TAVR procedures. [/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: Peri-Procedural Acute Coronary Syndrome During Transcatheter Aortic Valve Replacement ###Abstract: A 76-year-old male with severe chronic kidney disease, porcelain aorta and an oral squamous cell carcinoma (scheduled for chemotherapy and surgical excision) underwent transfemoral aortic valve replacement (TAVR) with a CoreValve Evolut R 34 due to severe aortic stenosis. The percutaneous treatment of a severely calcified stable lesion on ostial left circumflex (LCx) artery was not considered a priority due to the patient's comorbidities and the concerns about dual antiplatelet therapy. However, shortly afterwards valve deployment the patient developed an acute myocardial ischemia on the lateral wall due to LCx artery lesion becoming unstable; it was successfully treated with urgent coronary angioplasty and drug eluting stent implantation. A combination of multiple precipitating factors could be involved in the development of acute coronary syndrome during TAVR procedures. [/INST] Exclude </s>
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Lee 2016
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Saphenous Vein Graft Interventions
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Saphenous vein graft interventions compose a small but important subset of percutaneous coronary revascularization. Because of their unique biology, percutaneous angioplasty and stenting require tailored patient and lesion selection and modification of intervention technique to optimize outcomes. The use of embolic protection and appropriate adjunctive pharmacology can help minimize periprocedural complications, such as the no-reflow phenomenon. Recommendations for best practice in saphenous vein graft interventions continue to evolve with emerging research and therapy.
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Exclude
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DE9 - Unavailable
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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: Saphenous Vein Graft Interventions ###Abstract: Saphenous vein graft interventions compose a small but important subset of percutaneous coronary revascularization. Because of their unique biology, percutaneous angioplasty and stenting require tailored patient and lesion selection and modification of intervention technique to optimize outcomes. The use of embolic protection and appropriate adjunctive pharmacology can help minimize periprocedural complications, such as the no-reflow phenomenon. Recommendations for best practice in saphenous vein graft interventions continue to evolve with emerging research and therapy. [/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: Saphenous Vein Graft Interventions ###Abstract: Saphenous vein graft interventions compose a small but important subset of percutaneous coronary revascularization. Because of their unique biology, percutaneous angioplasty and stenting require tailored patient and lesion selection and modification of intervention technique to optimize outcomes. The use of embolic protection and appropriate adjunctive pharmacology can help minimize periprocedural complications, such as the no-reflow phenomenon. Recommendations for best practice in saphenous vein graft interventions continue to evolve with emerging research and therapy. [/INST] Exclude </s>
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Lee 2018
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Ultrasound-Guided Direct Needle Engagement for Flush-Occluded Superficial Femoral Artery
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Flush ostial occlusion of the superficial femoral artery (SFA) is challenging for endovascular treatment. Neither ipsilateral nor contralateral access is easy. The drawback of ipsilateral common femoral artery (CFA) access is that the CFA is too short for catheter manipulation and sheath engagement. Contralateral retrograde CFA access could have merit, but it has the drawback of poor pushability and torquability in the manipulation of devices. The most challenging part of flush ostial occlusion is the difficulty of wire engagement into the SFA orifice. We describe a case of successful treatment of a flush-occluded long SFA lesion using ultrasound-guided direct ipsilateral ostial access.
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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: Ultrasound-Guided Direct Needle Engagement for Flush-Occluded Superficial Femoral Artery ###Abstract: Flush ostial occlusion of the superficial femoral artery (SFA) is challenging for endovascular treatment. Neither ipsilateral nor contralateral access is easy. The drawback of ipsilateral common femoral artery (CFA) access is that the CFA is too short for catheter manipulation and sheath engagement. Contralateral retrograde CFA access could have merit, but it has the drawback of poor pushability and torquability in the manipulation of devices. The most challenging part of flush ostial occlusion is the difficulty of wire engagement into the SFA orifice. We describe a case of successful treatment of a flush-occluded long SFA lesion using ultrasound-guided direct ipsilateral ostial access. [/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: Ultrasound-Guided Direct Needle Engagement for Flush-Occluded Superficial Femoral Artery ###Abstract: Flush ostial occlusion of the superficial femoral artery (SFA) is challenging for endovascular treatment. Neither ipsilateral nor contralateral access is easy. The drawback of ipsilateral common femoral artery (CFA) access is that the CFA is too short for catheter manipulation and sheath engagement. Contralateral retrograde CFA access could have merit, but it has the drawback of poor pushability and torquability in the manipulation of devices. The most challenging part of flush ostial occlusion is the difficulty of wire engagement into the SFA orifice. We describe a case of successful treatment of a flush-occluded long SFA lesion using ultrasound-guided direct ipsilateral ostial access. [/INST] Exclude </s>
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Leibundgut 2018
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Transcutaneous Puncture of an Undeflatable Coronary Angioplasty Balloon Catheter
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This case report describes a quick and safe method to successfully retrieve an undeflatable angioplasty balloon via the transradial access site. The article also presents potential mechanisms of contrast media entrapment and bench tests of guidewire-assisted balloon puncture. After successful stent implantation in the proximal right coronary artery in a 74-year-old female patient referred for acute coronary syndrome, the balloon catheter became undeflatable for an unknown reason. Several attempts to burst the balloon in the guide catheter and the aorta failed. After a pullback into the radial artery, the still inflated balloon became stuck again and was unable to be retrieved through the sheath. Finally, transcutaneous puncture and aspiration of contrast media with a 23 gauge syringe needle through the skin in the right forearm allowed deflation and successful removal the balloon.
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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: Transcutaneous Puncture of an Undeflatable Coronary Angioplasty Balloon Catheter ###Abstract: This case report describes a quick and safe method to successfully retrieve an undeflatable angioplasty balloon via the transradial access site. The article also presents potential mechanisms of contrast media entrapment and bench tests of guidewire-assisted balloon puncture. After successful stent implantation in the proximal right coronary artery in a 74-year-old female patient referred for acute coronary syndrome, the balloon catheter became undeflatable for an unknown reason. Several attempts to burst the balloon in the guide catheter and the aorta failed. After a pullback into the radial artery, the still inflated balloon became stuck again and was unable to be retrieved through the sheath. Finally, transcutaneous puncture and aspiration of contrast media with a 23 gauge syringe needle through the skin in the right forearm allowed deflation and successful removal the balloon. [/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: Transcutaneous Puncture of an Undeflatable Coronary Angioplasty Balloon Catheter ###Abstract: This case report describes a quick and safe method to successfully retrieve an undeflatable angioplasty balloon via the transradial access site. The article also presents potential mechanisms of contrast media entrapment and bench tests of guidewire-assisted balloon puncture. After successful stent implantation in the proximal right coronary artery in a 74-year-old female patient referred for acute coronary syndrome, the balloon catheter became undeflatable for an unknown reason. Several attempts to burst the balloon in the guide catheter and the aorta failed. After a pullback into the radial artery, the still inflated balloon became stuck again and was unable to be retrieved through the sheath. Finally, transcutaneous puncture and aspiration of contrast media with a 23 gauge syringe needle through the skin in the right forearm allowed deflation and successful removal the balloon. [/INST] Exclude </s>
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Liao 2019
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Randomized controlled trial of orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for treatment of femoropopliteal artery in-stent restenosis
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Background: To assess the efficacy and safety of Orchid drug-coated balloon (DCB) for treatment of femoropopliteal (FP) artery in-stent restenosis (ISR) in Chinese patients. Methods: The study is a prospective, single center, single-blinded, randomized controlled trial (RCT) that randomized (1:1) 74 patients to DCB group (N.=38) and PTA group (N.=36). The primary efficacy endpoint was primary patency of the target lesion at 12 months. Second efficacy endpoint included clinically-driven target-lesion revascularization (CD-TLR) and ABI change at 12 months. The primary safety endpoint included peri-operative death at 30 days, all-cause death, major amputation, and other major adverse events (MAEs) at 12 months. The primary functional endpoint included Walking Impairment Questionnaire (WIQ), quality-of-life measures (EQ-5D) and 6-minute walking test (6MWT). Results: The DCB group had higher primary patency (87.9% vs. 51.6%; P=0.001) and lower rates of CD-TLR (6.1% vs. 35.5%; P=0.003) than the PTA group at 12 months. There were no peri-operative deaths, and no major amputations at 12 months in two groups. There were 1(2.6%) in the DCB group and 2 (5.6%) in the PTA group of all-cause deaths (P=0.524). Conclusions: Results from the study showed superior treatment effect with Orchid DCB versus PTA for the treatment of FP ISR, and without an apparent difference in safety. (Cite this article as: Liao C, Song S, Li T, Zhang Y, Zhang W. Randomized controlled trial of orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for treatment of femoropopliteal artery in-stent restenosis.
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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: Randomized controlled trial of orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for treatment of femoropopliteal artery in-stent restenosis ###Abstract: Background: To assess the efficacy and safety of Orchid drug-coated balloon (DCB) for treatment of femoropopliteal (FP) artery in-stent restenosis (ISR) in Chinese patients. Methods: The study is a prospective, single center, single-blinded, randomized controlled trial (RCT) that randomized (1:1) 74 patients to DCB group (N.=38) and PTA group (N.=36). The primary efficacy endpoint was primary patency of the target lesion at 12 months. Second efficacy endpoint included clinically-driven target-lesion revascularization (CD-TLR) and ABI change at 12 months. The primary safety endpoint included peri-operative death at 30 days, all-cause death, major amputation, and other major adverse events (MAEs) at 12 months. The primary functional endpoint included Walking Impairment Questionnaire (WIQ), quality-of-life measures (EQ-5D) and 6-minute walking test (6MWT). Results: The DCB group had higher primary patency (87.9% vs. 51.6%; P=0.001) and lower rates of CD-TLR (6.1% vs. 35.5%; P=0.003) than the PTA group at 12 months. There were no peri-operative deaths, and no major amputations at 12 months in two groups. There were 1(2.6%) in the DCB group and 2 (5.6%) in the PTA group of all-cause deaths (P=0.524). Conclusions: Results from the study showed superior treatment effect with Orchid DCB versus PTA for the treatment of FP ISR, and without an apparent difference in safety. (Cite this article as: Liao C, Song S, Li T, Zhang Y, Zhang W. Randomized controlled trial of orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for treatment of femoropopliteal artery in-stent restenosis. [/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 of orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for treatment of femoropopliteal artery in-stent restenosis ###Abstract: Background: To assess the efficacy and safety of Orchid drug-coated balloon (DCB) for treatment of femoropopliteal (FP) artery in-stent restenosis (ISR) in Chinese patients. Methods: The study is a prospective, single center, single-blinded, randomized controlled trial (RCT) that randomized (1:1) 74 patients to DCB group (N.=38) and PTA group (N.=36). The primary efficacy endpoint was primary patency of the target lesion at 12 months. Second efficacy endpoint included clinically-driven target-lesion revascularization (CD-TLR) and ABI change at 12 months. The primary safety endpoint included peri-operative death at 30 days, all-cause death, major amputation, and other major adverse events (MAEs) at 12 months. The primary functional endpoint included Walking Impairment Questionnaire (WIQ), quality-of-life measures (EQ-5D) and 6-minute walking test (6MWT). Results: The DCB group had higher primary patency (87.9% vs. 51.6%; P=0.001) and lower rates of CD-TLR (6.1% vs. 35.5%; P=0.003) than the PTA group at 12 months. There were no peri-operative deaths, and no major amputations at 12 months in two groups. There were 1(2.6%) in the DCB group and 2 (5.6%) in the PTA group of all-cause deaths (P=0.524). Conclusions: Results from the study showed superior treatment effect with Orchid DCB versus PTA for the treatment of FP ISR, and without an apparent difference in safety. (Cite this article as: Liao C, Song S, Li T, Zhang Y, Zhang W. Randomized controlled trial of orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for treatment of femoropopliteal artery in-stent restenosis. [/INST] Exclude </s>
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Liistro 2020
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Paclitaxel-coated balloons in peripheral artery disease: How much is enough?
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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: Paclitaxel-coated balloons in peripheral artery disease: How much is enough? ###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: Paclitaxel-coated balloons in peripheral artery disease: How much is enough? ###Abstract: None [/INST] Exclude </s>
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Marchese 2020
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A cascade of multiple complications hampering a complex high-risk percutaneous coronary intervention (CHIP-PCI): When ingenuity overcomes troubles!
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Even skilled CHIP operators can run into multiple complications. Some are unexpected and not related to the operator, and others are fully preventable by careful procedural choices. If those occur, the knowledge of devices and cognitive skills become lifesaving elements and sudden issues need to be dealt with calmly and efficiently.
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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: A cascade of multiple complications hampering a complex high-risk percutaneous coronary intervention (CHIP-PCI): When ingenuity overcomes troubles! ###Abstract: Even skilled CHIP operators can run into multiple complications. Some are unexpected and not related to the operator, and others are fully preventable by careful procedural choices. If those occur, the knowledge of devices and cognitive skills become lifesaving elements and sudden issues need to be dealt with calmly and efficiently. [/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 cascade of multiple complications hampering a complex high-risk percutaneous coronary intervention (CHIP-PCI): When ingenuity overcomes troubles! ###Abstract: Even skilled CHIP operators can run into multiple complications. Some are unexpected and not related to the operator, and others are fully preventable by careful procedural choices. If those occur, the knowledge of devices and cognitive skills become lifesaving elements and sudden issues need to be dealt with calmly and efficiently. [/INST] Exclude </s>
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Marques 2016
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Drug-coated balloons: What is the evidence?
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Having evolved at a rapid pace, the therapy options for percutaneous treatment of peripheral arterial disease in the lower limbs, especially percutaneous transluminal angioplasty in combination with stent-Technology, are able to deliver a rate where at least 80% of the treated patients remain free from reintervention after the first years under ideal study conditions, meaning that defined and often restrict in-and exclusion criteria were fulfilled and mid-Term dual platelet therapy is warranted. This is somewhat a huge leap when compared to the 50-60% in the 1980s and 1990s, but we now face an era of an increasingly demanding clientele, where the industry also strives to cover this final 20% with newer technologies. As recent studies with drug-eluting stents (DES) suggests, nowadays it is possible to achieve up to 90% patency in the short-and mid-Term, but this comes accompanied by remarkably increased therapy costs, making it almost impossible to most centers to implant it as the standard therapy option. Trying to fill this gap between the low-patency of the plain old balloon angioplasty and the higher costs of the DES, drug-coated balloon technology has found its niche, knowing that reimbursement shows a broad variation across the countries and continents.
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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: Drug-coated balloons: What is the evidence? ###Abstract: Having evolved at a rapid pace, the therapy options for percutaneous treatment of peripheral arterial disease in the lower limbs, especially percutaneous transluminal angioplasty in combination with stent-Technology, are able to deliver a rate where at least 80% of the treated patients remain free from reintervention after the first years under ideal study conditions, meaning that defined and often restrict in-and exclusion criteria were fulfilled and mid-Term dual platelet therapy is warranted. This is somewhat a huge leap when compared to the 50-60% in the 1980s and 1990s, but we now face an era of an increasingly demanding clientele, where the industry also strives to cover this final 20% with newer technologies. As recent studies with drug-eluting stents (DES) suggests, nowadays it is possible to achieve up to 90% patency in the short-and mid-Term, but this comes accompanied by remarkably increased therapy costs, making it almost impossible to most centers to implant it as the standard therapy option. Trying to fill this gap between the low-patency of the plain old balloon angioplasty and the higher costs of the DES, drug-coated balloon technology has found its niche, knowing that reimbursement shows a broad variation across the countries and continents. [/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: What is the evidence? ###Abstract: Having evolved at a rapid pace, the therapy options for percutaneous treatment of peripheral arterial disease in the lower limbs, especially percutaneous transluminal angioplasty in combination with stent-Technology, are able to deliver a rate where at least 80% of the treated patients remain free from reintervention after the first years under ideal study conditions, meaning that defined and often restrict in-and exclusion criteria were fulfilled and mid-Term dual platelet therapy is warranted. This is somewhat a huge leap when compared to the 50-60% in the 1980s and 1990s, but we now face an era of an increasingly demanding clientele, where the industry also strives to cover this final 20% with newer technologies. As recent studies with drug-eluting stents (DES) suggests, nowadays it is possible to achieve up to 90% patency in the short-and mid-Term, but this comes accompanied by remarkably increased therapy costs, making it almost impossible to most centers to implant it as the standard therapy option. Trying to fill this gap between the low-patency of the plain old balloon angioplasty and the higher costs of the DES, drug-coated balloon technology has found its niche, knowing that reimbursement shows a broad variation across the countries and continents. [/INST] Exclude </s>
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Marquis-Gravel 2017
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Impact of paclitaxel-eluting balloons compared to second-generation drug-eluting stents for of in-stent restenosis in a primarily acute coronary syndrome population
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Background: The place of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) is not well-defined, particularly in a population of all-comers with acute coronary syndromes (ACS). Objective: Compare the clinical outcomes of DEB with second-generation drug-eluting stents (DES) for the treatment of ISR in a real-world population with a high proportion of ACS. Methods: A retrospective analysis of consecutive patients with ISR treated with a DEB compared to patients treated with a second-generation DES was performed. The primary endpoint was a composite of major adverse cardiovascular events (MACE: all-cause death, non-fatal myocardial infarction, and target lesion revascularization). Comparisons were performed using Cox proportional hazards multivariate adjustment and Kaplan-Meier analysis with log-rank. Results: The cohort included 91 patients treated with a DEB and 89 patients treated with a DES (74% ACS). Median follow-up was 26 months. MACE occurred in 33 patients (36%) in the DEB group, compared to 17 patients (19%) in the DES group (p log-rank = 0.02). After multivariate adjustment, there was no significant difference between the groups (HR for DEB = 1.45 [95%CI: 0.75-2.83]; p = 0.27). Mortality rates at 1 year were 11% with DEB, and 3% with DES (p = 0.04; adjusted HR = 2.85 [95%CI: 0.98-8.32]; p = 0.06). Conclusion: In a population with a high proportion of ACS, a non-significant numerical signal towards increased rates of MACE with DEB compared to second-generation DES for the treatment of ISR was observed, mainly driven by a higher mortality rate. An adequately-powered randomized controlled trial is necessary to confirm these findings.
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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 paclitaxel-eluting balloons compared to second-generation drug-eluting stents for of in-stent restenosis in a primarily acute coronary syndrome population ###Abstract: Background: The place of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) is not well-defined, particularly in a population of all-comers with acute coronary syndromes (ACS). Objective: Compare the clinical outcomes of DEB with second-generation drug-eluting stents (DES) for the treatment of ISR in a real-world population with a high proportion of ACS. Methods: A retrospective analysis of consecutive patients with ISR treated with a DEB compared to patients treated with a second-generation DES was performed. The primary endpoint was a composite of major adverse cardiovascular events (MACE: all-cause death, non-fatal myocardial infarction, and target lesion revascularization). Comparisons were performed using Cox proportional hazards multivariate adjustment and Kaplan-Meier analysis with log-rank. Results: The cohort included 91 patients treated with a DEB and 89 patients treated with a DES (74% ACS). Median follow-up was 26 months. MACE occurred in 33 patients (36%) in the DEB group, compared to 17 patients (19%) in the DES group (p log-rank = 0.02). After multivariate adjustment, there was no significant difference between the groups (HR for DEB = 1.45 [95%CI: 0.75-2.83]; p = 0.27). Mortality rates at 1 year were 11% with DEB, and 3% with DES (p = 0.04; adjusted HR = 2.85 [95%CI: 0.98-8.32]; p = 0.06). Conclusion: In a population with a high proportion of ACS, a non-significant numerical signal towards increased rates of MACE with DEB compared to second-generation DES for the treatment of ISR was observed, mainly driven by a higher mortality rate. An adequately-powered randomized controlled trial is necessary to confirm these findings. [/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 paclitaxel-eluting balloons compared to second-generation drug-eluting stents for of in-stent restenosis in a primarily acute coronary syndrome population ###Abstract: Background: The place of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) is not well-defined, particularly in a population of all-comers with acute coronary syndromes (ACS). Objective: Compare the clinical outcomes of DEB with second-generation drug-eluting stents (DES) for the treatment of ISR in a real-world population with a high proportion of ACS. Methods: A retrospective analysis of consecutive patients with ISR treated with a DEB compared to patients treated with a second-generation DES was performed. The primary endpoint was a composite of major adverse cardiovascular events (MACE: all-cause death, non-fatal myocardial infarction, and target lesion revascularization). Comparisons were performed using Cox proportional hazards multivariate adjustment and Kaplan-Meier analysis with log-rank. Results: The cohort included 91 patients treated with a DEB and 89 patients treated with a DES (74% ACS). Median follow-up was 26 months. MACE occurred in 33 patients (36%) in the DEB group, compared to 17 patients (19%) in the DES group (p log-rank = 0.02). After multivariate adjustment, there was no significant difference between the groups (HR for DEB = 1.45 [95%CI: 0.75-2.83]; p = 0.27). Mortality rates at 1 year were 11% with DEB, and 3% with DES (p = 0.04; adjusted HR = 2.85 [95%CI: 0.98-8.32]; p = 0.06). Conclusion: In a population with a high proportion of ACS, a non-significant numerical signal towards increased rates of MACE with DEB compared to second-generation DES for the treatment of ISR was observed, mainly driven by a higher mortality rate. An adequately-powered randomized controlled trial is necessary to confirm these findings. [/INST] Exclude </s>
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Matsumoto 2017
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Successful treatment of very late drug-eluting stent thrombosis using bare-metal stent evaluated using intravascular ultrasound and optical frequency domain imaging
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A 65-year-old man who underwent percutaneous coronary intervention with sirolimus-eluting stents (SESs) 2 years ago was admitted with recurrent acute chest pain. Coronary angiography showed thrombotic occlusion within the SESs. After aspiration thrombectomy, multi-focal peri-stent contrast staining (PSS) was observed. Optical frequency domain imaging (OFDI) showed intracoronary thrombus, incomplete stent apposition (ISA), and multiple inter-strut hollows. Intravascular ultrasound (IVUS) images showed positive vessel remodeling. We deployed bare-metal stents in the SESs. Follow-up angiography showed no in-stent restenosis or PSS. OFDI showed well-covered stent surface with homogeneous neointima, without ISA. Additionally, IVUS images showed that the vessel remodeling had not worsened.
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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: Successful treatment of very late drug-eluting stent thrombosis using bare-metal stent evaluated using intravascular ultrasound and optical frequency domain imaging ###Abstract: A 65-year-old man who underwent percutaneous coronary intervention with sirolimus-eluting stents (SESs) 2 years ago was admitted with recurrent acute chest pain. Coronary angiography showed thrombotic occlusion within the SESs. After aspiration thrombectomy, multi-focal peri-stent contrast staining (PSS) was observed. Optical frequency domain imaging (OFDI) showed intracoronary thrombus, incomplete stent apposition (ISA), and multiple inter-strut hollows. Intravascular ultrasound (IVUS) images showed positive vessel remodeling. We deployed bare-metal stents in the SESs. Follow-up angiography showed no in-stent restenosis or PSS. OFDI showed well-covered stent surface with homogeneous neointima, without ISA. Additionally, IVUS images showed that the vessel remodeling had not worsened. [/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 treatment of very late drug-eluting stent thrombosis using bare-metal stent evaluated using intravascular ultrasound and optical frequency domain imaging ###Abstract: A 65-year-old man who underwent percutaneous coronary intervention with sirolimus-eluting stents (SESs) 2 years ago was admitted with recurrent acute chest pain. Coronary angiography showed thrombotic occlusion within the SESs. After aspiration thrombectomy, multi-focal peri-stent contrast staining (PSS) was observed. Optical frequency domain imaging (OFDI) showed intracoronary thrombus, incomplete stent apposition (ISA), and multiple inter-strut hollows. Intravascular ultrasound (IVUS) images showed positive vessel remodeling. We deployed bare-metal stents in the SESs. Follow-up angiography showed no in-stent restenosis or PSS. OFDI showed well-covered stent surface with homogeneous neointima, without ISA. Additionally, IVUS images showed that the vessel remodeling had not worsened. [/INST] Exclude </s>
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McLachlan 2019
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Endovascular treatment of critical lower limb ischemia caused by giant cell arteritis
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Giant cell arteritis (GCA) is a well-known cause of cranial vasculitis often presenting with headache and jaw claudication. Here we report the case of a woman suffering GCA who presented with critical lower limb ischemia. Despite best medical therapy, she developed progressive calf claudication and ulceration of the right foot. The findings on workup were highly suggestive of GCA involving the superficial femoral artery. The limb was successfully revascularized with angioplasty and placement of a drug-eluting stent. GCA is an important cause of lower limb ischemia and should be considered in patients without evidence of atherosclerosis. Endovascular intervention is a feasible treatment of critical limb ischemia due to GCA and has been shown to be safe in this case.
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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: Endovascular treatment of critical lower limb ischemia caused by giant cell arteritis ###Abstract: Giant cell arteritis (GCA) is a well-known cause of cranial vasculitis often presenting with headache and jaw claudication. Here we report the case of a woman suffering GCA who presented with critical lower limb ischemia. Despite best medical therapy, she developed progressive calf claudication and ulceration of the right foot. The findings on workup were highly suggestive of GCA involving the superficial femoral artery. The limb was successfully revascularized with angioplasty and placement of a drug-eluting stent. GCA is an important cause of lower limb ischemia and should be considered in patients without evidence of atherosclerosis. Endovascular intervention is a feasible treatment of critical limb ischemia due to GCA and has been shown to be safe in this case. [/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 critical lower limb ischemia caused by giant cell arteritis ###Abstract: Giant cell arteritis (GCA) is a well-known cause of cranial vasculitis often presenting with headache and jaw claudication. Here we report the case of a woman suffering GCA who presented with critical lower limb ischemia. Despite best medical therapy, she developed progressive calf claudication and ulceration of the right foot. The findings on workup were highly suggestive of GCA involving the superficial femoral artery. The limb was successfully revascularized with angioplasty and placement of a drug-eluting stent. GCA is an important cause of lower limb ischemia and should be considered in patients without evidence of atherosclerosis. Endovascular intervention is a feasible treatment of critical limb ischemia due to GCA and has been shown to be safe in this case. [/INST] Exclude </s>
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Meneguz 2018
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Drug-Coated Balloons: Hope or Hot Air: Update on the Role of Coronary DCB
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Purpose of Review: The present manuscript reviews the mechanism of action of drug-coated balloons (DCBs), offering a brief summary of the main clinical evidence on these devices. Recent Findings: DCBs are regular semi-compliant balloons coated with antiproliferative agents that are rapidly released on contact with the vessel intima, exerting an anti-restenotic effect. This technology may offer some benefits of drug-eluting stents, in particular for the treatment of restenotic lesions, small vessels, and in patients at high-bleeding risk, when the prolonged dual antiplatelet regimen should be avoided. Most recent data have pointed to a possible benefit of these devices in treating bare metal stents (BMS) or drug-eluting stents in-stent restenosis (DES ISR), effectively reducing the recurrence of restenosis and avoiding additional layers of metal in the same coronary segment. In other clinical scenarios such as bifurcations, small vessels, and de novo lesions, data is more scarce and the benefits are still unclear. Summary: There are potential benefits related to the use of DCB in selected populations. However, larger clinical trials with longer follow-up are still needed to confirm the enthusiastic initial results.
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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: Drug-Coated Balloons: Hope or Hot Air: Update on the Role of Coronary DCB ###Abstract: Purpose of Review: The present manuscript reviews the mechanism of action of drug-coated balloons (DCBs), offering a brief summary of the main clinical evidence on these devices. Recent Findings: DCBs are regular semi-compliant balloons coated with antiproliferative agents that are rapidly released on contact with the vessel intima, exerting an anti-restenotic effect. This technology may offer some benefits of drug-eluting stents, in particular for the treatment of restenotic lesions, small vessels, and in patients at high-bleeding risk, when the prolonged dual antiplatelet regimen should be avoided. Most recent data have pointed to a possible benefit of these devices in treating bare metal stents (BMS) or drug-eluting stents in-stent restenosis (DES ISR), effectively reducing the recurrence of restenosis and avoiding additional layers of metal in the same coronary segment. In other clinical scenarios such as bifurcations, small vessels, and de novo lesions, data is more scarce and the benefits are still unclear. Summary: There are potential benefits related to the use of DCB in selected populations. However, larger clinical trials with longer follow-up are still needed to confirm the enthusiastic initial 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: Hope or Hot Air: Update on the Role of Coronary DCB ###Abstract: Purpose of Review: The present manuscript reviews the mechanism of action of drug-coated balloons (DCBs), offering a brief summary of the main clinical evidence on these devices. Recent Findings: DCBs are regular semi-compliant balloons coated with antiproliferative agents that are rapidly released on contact with the vessel intima, exerting an anti-restenotic effect. This technology may offer some benefits of drug-eluting stents, in particular for the treatment of restenotic lesions, small vessels, and in patients at high-bleeding risk, when the prolonged dual antiplatelet regimen should be avoided. Most recent data have pointed to a possible benefit of these devices in treating bare metal stents (BMS) or drug-eluting stents in-stent restenosis (DES ISR), effectively reducing the recurrence of restenosis and avoiding additional layers of metal in the same coronary segment. In other clinical scenarios such as bifurcations, small vessels, and de novo lesions, data is more scarce and the benefits are still unclear. Summary: There are potential benefits related to the use of DCB in selected populations. However, larger clinical trials with longer follow-up are still needed to confirm the enthusiastic initial results. [/INST] Exclude </s>
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Mohiaddin 2018
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Drug-Coated Balloon-Only Percutaneous Coronary Intervention for the Treatment of De Novo Coronary Artery Disease: A Systematic Review
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Percutaneous coronary intervention (PCI) with a drug coated balloon (DCB) is a novel treatment which seeks to acutely dilate a coronary stenosis and deliver an anti-proliferative drug to the vessel wall (reducing the risk of re-stenosis), without implanting a drug eluting stent (DES). In this study, we performed a systematic review of stentless DCB-only angioplasty in de novo coronary artery disease. We identified 41 studies examining the effects of DCB-only PCI in a variety of clinical scenarios including small vessels, bifurcations, calcified lesions, and primary PCI. DCB-only PCI appears to be associated with comparable clinical outcomes to DESs and superior angiographic outcomes to plain-old balloon angioplasty. Although current data are promising, there is still a need for further long-term randomized control trial data comparing a DCB-only approach specifically against a second- or third-generation DES. A 4-week period of dual antiplatelet therapy provides a real advantage for the DCB-only PCI approach, which is not possible with most DESs. Since rates of adverse clinical outcomes are very low for all PCI procedures attention should be turned to the development of robust endpoints with which to compare DCB-only PCI approaches to the standard treatment with a DES.
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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: Drug-Coated Balloon-Only Percutaneous Coronary Intervention for the Treatment of De Novo Coronary Artery Disease: A Systematic Review ###Abstract: Percutaneous coronary intervention (PCI) with a drug coated balloon (DCB) is a novel treatment which seeks to acutely dilate a coronary stenosis and deliver an anti-proliferative drug to the vessel wall (reducing the risk of re-stenosis), without implanting a drug eluting stent (DES). In this study, we performed a systematic review of stentless DCB-only angioplasty in de novo coronary artery disease. We identified 41 studies examining the effects of DCB-only PCI in a variety of clinical scenarios including small vessels, bifurcations, calcified lesions, and primary PCI. DCB-only PCI appears to be associated with comparable clinical outcomes to DESs and superior angiographic outcomes to plain-old balloon angioplasty. Although current data are promising, there is still a need for further long-term randomized control trial data comparing a DCB-only approach specifically against a second- or third-generation DES. A 4-week period of dual antiplatelet therapy provides a real advantage for the DCB-only PCI approach, which is not possible with most DESs. Since rates of adverse clinical outcomes are very low for all PCI procedures attention should be turned to the development of robust endpoints with which to compare DCB-only PCI approaches to the standard treatment with a DES. [/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-Only Percutaneous Coronary Intervention for the Treatment of De Novo Coronary Artery Disease: A Systematic Review ###Abstract: Percutaneous coronary intervention (PCI) with a drug coated balloon (DCB) is a novel treatment which seeks to acutely dilate a coronary stenosis and deliver an anti-proliferative drug to the vessel wall (reducing the risk of re-stenosis), without implanting a drug eluting stent (DES). In this study, we performed a systematic review of stentless DCB-only angioplasty in de novo coronary artery disease. We identified 41 studies examining the effects of DCB-only PCI in a variety of clinical scenarios including small vessels, bifurcations, calcified lesions, and primary PCI. DCB-only PCI appears to be associated with comparable clinical outcomes to DESs and superior angiographic outcomes to plain-old balloon angioplasty. Although current data are promising, there is still a need for further long-term randomized control trial data comparing a DCB-only approach specifically against a second- or third-generation DES. A 4-week period of dual antiplatelet therapy provides a real advantage for the DCB-only PCI approach, which is not possible with most DESs. Since rates of adverse clinical outcomes are very low for all PCI procedures attention should be turned to the development of robust endpoints with which to compare DCB-only PCI approaches to the standard treatment with a DES. [/INST] Exclude </s>
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Monteleone 2020
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The market reacts quickly: Changes in paclitaxel vascular device purchasing within the ascension healthcare system
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Background. A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has issued multiple advisories regarding paclitaxel use. We analyzed how this controversy impacted device purchasing and related utilization patterns in the period immediately following publication of the meta-analysis. Methods and Results. Ascension Healthcare System purchase data over a 14-month period were synthesized across centers for both paclitaxel and non-paclitaxel devices. A fixed-effects regression model and a binary regression model with facility-level controls were used to compare purchasing patterns before and after the meta-analysis. Purchase volumes of each paclitaxel device fell. Pooled purchase volumes of all paclitaxel devices decreased from a 14-month peak of 631 devices in October 2018 to a 14-month nadir of 359 devices in February 2019. An F-test comparing the pooled-month specific fixed effects for the months before vs after the publication of the meta-analysis has an F-statistic of 11.64, suggesting that average purchasing levels in the two periods are statistically different (P<.001). Utilization of non-paclitaxel devices did not decline. Conclusions. Purchase volumes of paclitaxel devices decreased immediately during the months following publication of the related meta-analysis. Total Ascension-wide paclitaxel device purchase volume in February 2019 demonstrated a 43.1% reduction from peak monthly purchase volume during the assessed period and a 32.5% reduction compared with November 2019, the last month preceding publication of the meta-analysis.
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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: The market reacts quickly: Changes in paclitaxel vascular device purchasing within the ascension healthcare system ###Abstract: Background. A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has issued multiple advisories regarding paclitaxel use. We analyzed how this controversy impacted device purchasing and related utilization patterns in the period immediately following publication of the meta-analysis. Methods and Results. Ascension Healthcare System purchase data over a 14-month period were synthesized across centers for both paclitaxel and non-paclitaxel devices. A fixed-effects regression model and a binary regression model with facility-level controls were used to compare purchasing patterns before and after the meta-analysis. Purchase volumes of each paclitaxel device fell. Pooled purchase volumes of all paclitaxel devices decreased from a 14-month peak of 631 devices in October 2018 to a 14-month nadir of 359 devices in February 2019. An F-test comparing the pooled-month specific fixed effects for the months before vs after the publication of the meta-analysis has an F-statistic of 11.64, suggesting that average purchasing levels in the two periods are statistically different (P<.001). Utilization of non-paclitaxel devices did not decline. Conclusions. Purchase volumes of paclitaxel devices decreased immediately during the months following publication of the related meta-analysis. Total Ascension-wide paclitaxel device purchase volume in February 2019 demonstrated a 43.1% reduction from peak monthly purchase volume during the assessed period and a 32.5% reduction compared with November 2019, the last month preceding publication of the meta-analysis. [/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 market reacts quickly: Changes in paclitaxel vascular device purchasing within the ascension healthcare system ###Abstract: Background. A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has issued multiple advisories regarding paclitaxel use. We analyzed how this controversy impacted device purchasing and related utilization patterns in the period immediately following publication of the meta-analysis. Methods and Results. Ascension Healthcare System purchase data over a 14-month period were synthesized across centers for both paclitaxel and non-paclitaxel devices. A fixed-effects regression model and a binary regression model with facility-level controls were used to compare purchasing patterns before and after the meta-analysis. Purchase volumes of each paclitaxel device fell. Pooled purchase volumes of all paclitaxel devices decreased from a 14-month peak of 631 devices in October 2018 to a 14-month nadir of 359 devices in February 2019. An F-test comparing the pooled-month specific fixed effects for the months before vs after the publication of the meta-analysis has an F-statistic of 11.64, suggesting that average purchasing levels in the two periods are statistically different (P<.001). Utilization of non-paclitaxel devices did not decline. Conclusions. Purchase volumes of paclitaxel devices decreased immediately during the months following publication of the related meta-analysis. Total Ascension-wide paclitaxel device purchase volume in February 2019 demonstrated a 43.1% reduction from peak monthly purchase volume during the assessed period and a 32.5% reduction compared with November 2019, the last month preceding publication of the meta-analysis. [/INST] Exclude </s>
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Moretti 2019
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Ultra-Deep Guide Catheter Intubation for Direct Thromboaspiration in Acute Myocardial Infarction
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Thrombus burden remains an important mortality risk factor during primary percutaneous coronary interventions (PCI), especially when associated with distal embolization of atheromatous debris (Sharma et al., 2016; Ibanez et al., 2018 [1,2]). Although routine thrombus aspiration during primary PCI in acute coronary syndrome (ACS) is not recommended (Sharma et al., 2016 [1]), some procedures become very challenging when thrombus removal and vessel reperfusion is not achieved with conventional dedicated devices. We describe a case of a 60-year old man with a late-comer infero-lateral ST–segment elevation myocardial infarction (STEMI) undergoing right coronary artery primary PCI. A high thrombotic burden was shown requiring an ultra-deep guide catheter intubation to perform a successful thromboaspiration and stenting.
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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: Ultra-Deep Guide Catheter Intubation for Direct Thromboaspiration in Acute Myocardial Infarction ###Abstract: Thrombus burden remains an important mortality risk factor during primary percutaneous coronary interventions (PCI), especially when associated with distal embolization of atheromatous debris (Sharma et al., 2016; Ibanez et al., 2018 [1,2]). Although routine thrombus aspiration during primary PCI in acute coronary syndrome (ACS) is not recommended (Sharma et al., 2016 [1]), some procedures become very challenging when thrombus removal and vessel reperfusion is not achieved with conventional dedicated devices. We describe a case of a 60-year old man with a late-comer infero-lateral ST–segment elevation myocardial infarction (STEMI) undergoing right coronary artery primary PCI. A high thrombotic burden was shown requiring an ultra-deep guide catheter intubation to perform a successful thromboaspiration and stenting. [/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: Ultra-Deep Guide Catheter Intubation for Direct Thromboaspiration in Acute Myocardial Infarction ###Abstract: Thrombus burden remains an important mortality risk factor during primary percutaneous coronary interventions (PCI), especially when associated with distal embolization of atheromatous debris (Sharma et al., 2016; Ibanez et al., 2018 [1,2]). Although routine thrombus aspiration during primary PCI in acute coronary syndrome (ACS) is not recommended (Sharma et al., 2016 [1]), some procedures become very challenging when thrombus removal and vessel reperfusion is not achieved with conventional dedicated devices. We describe a case of a 60-year old man with a late-comer infero-lateral ST–segment elevation myocardial infarction (STEMI) undergoing right coronary artery primary PCI. A high thrombotic burden was shown requiring an ultra-deep guide catheter intubation to perform a successful thromboaspiration and stenting. [/INST] Exclude </s>
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Moscarella 2018
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Bioresorbable vascular scaffold versus everolimus-eluting stents or drug eluting balloon for the treatment of coronary in-stent restenosis: 1-Year follow-up of a propensity score matching comparison (the BIORESOLVE-ISR Study)
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Objectives: to compare the 1-year outcome between bioresorbable vascular scaffold (BVS), everolimus-eluting stent (EES), and drug-eluting balloon (DEB) for in-stent restenosis (ISR) treatment. Background: BVS has been proposed as alternative for ISR treatment. To date a direct comparison between BVS and DES or DEB for ISR treatment is lacking. Methods: We retrospectively analyzed all ISR lesions treated with BVS, DEB, and EES from January 2012 to December 2014. A total of 548 lesions (498 patients) were included. By applying two propensity-score matching, 93 lesions treated with BVS were compared with 93 lesions treated with DEB, and 100 lesions treated with BVS were compared to 100 lesions treated with EES. Results: At 1-year follow-up the incidence of device-oriented cardiovascular events (DOCE) and its components did not significantly differ between BVS and DEB (DOCE: 10.9 vs. 11.8%, HR, 0.91; 95% CI, 0.33–2.52; P = 0.86; Cardiac death: 2.2 vs. 1.2%, HR, 1.74, 95% CI 0.16–18.80, P = 0.65; ID-TLR: 8.9 vs. 10.7%, HR, 0.81, 95% CI 0.27–2.48, P = 0.71; TV-MI: 3.3 vs. 1.2%, HR, 2.39, 95% CI 0.27–21.32, P = 0.43) and BVS vs. EES (DOCE: 10.1 vs. 5.2% HR, 1.81, 95% CI, 0.63–5.25; P = 0.27; Cardiac death: 3.0 vs. 1.1%; HR, 2.83, 95% CI 0.29–27.4, P = 0.37; ID-TLR: 7.2 vs. 4.2%, HR, 1.57, 95% CI 0.47–5.23, P = 0.46; TV-MI: 3.1 vs. 0%). Conclusion: At 1-year follow-up the use of BVS as ISR treatment is associated with a higher, even if not significant, DOCE rate compared with EES while a similar rate compared to DEB.
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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: Bioresorbable vascular scaffold versus everolimus-eluting stents or drug eluting balloon for the treatment of coronary in-stent restenosis: 1-Year follow-up of a propensity score matching comparison (the BIORESOLVE-ISR Study) ###Abstract: Objectives: to compare the 1-year outcome between bioresorbable vascular scaffold (BVS), everolimus-eluting stent (EES), and drug-eluting balloon (DEB) for in-stent restenosis (ISR) treatment. Background: BVS has been proposed as alternative for ISR treatment. To date a direct comparison between BVS and DES or DEB for ISR treatment is lacking. Methods: We retrospectively analyzed all ISR lesions treated with BVS, DEB, and EES from January 2012 to December 2014. A total of 548 lesions (498 patients) were included. By applying two propensity-score matching, 93 lesions treated with BVS were compared with 93 lesions treated with DEB, and 100 lesions treated with BVS were compared to 100 lesions treated with EES. Results: At 1-year follow-up the incidence of device-oriented cardiovascular events (DOCE) and its components did not significantly differ between BVS and DEB (DOCE: 10.9 vs. 11.8%, HR, 0.91; 95% CI, 0.33–2.52; P = 0.86; Cardiac death: 2.2 vs. 1.2%, HR, 1.74, 95% CI 0.16–18.80, P = 0.65; ID-TLR: 8.9 vs. 10.7%, HR, 0.81, 95% CI 0.27–2.48, P = 0.71; TV-MI: 3.3 vs. 1.2%, HR, 2.39, 95% CI 0.27–21.32, P = 0.43) and BVS vs. EES (DOCE: 10.1 vs. 5.2% HR, 1.81, 95% CI, 0.63–5.25; P = 0.27; Cardiac death: 3.0 vs. 1.1%; HR, 2.83, 95% CI 0.29–27.4, P = 0.37; ID-TLR: 7.2 vs. 4.2%, HR, 1.57, 95% CI 0.47–5.23, P = 0.46; TV-MI: 3.1 vs. 0%). Conclusion: At 1-year follow-up the use of BVS as ISR treatment is associated with a higher, even if not significant, DOCE rate compared with EES while a similar rate compared to DEB. [/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: Bioresorbable vascular scaffold versus everolimus-eluting stents or drug eluting balloon for the treatment of coronary in-stent restenosis: 1-Year follow-up of a propensity score matching comparison (the BIORESOLVE-ISR Study) ###Abstract: Objectives: to compare the 1-year outcome between bioresorbable vascular scaffold (BVS), everolimus-eluting stent (EES), and drug-eluting balloon (DEB) for in-stent restenosis (ISR) treatment. Background: BVS has been proposed as alternative for ISR treatment. To date a direct comparison between BVS and DES or DEB for ISR treatment is lacking. Methods: We retrospectively analyzed all ISR lesions treated with BVS, DEB, and EES from January 2012 to December 2014. A total of 548 lesions (498 patients) were included. By applying two propensity-score matching, 93 lesions treated with BVS were compared with 93 lesions treated with DEB, and 100 lesions treated with BVS were compared to 100 lesions treated with EES. Results: At 1-year follow-up the incidence of device-oriented cardiovascular events (DOCE) and its components did not significantly differ between BVS and DEB (DOCE: 10.9 vs. 11.8%, HR, 0.91; 95% CI, 0.33–2.52; P = 0.86; Cardiac death: 2.2 vs. 1.2%, HR, 1.74, 95% CI 0.16–18.80, P = 0.65; ID-TLR: 8.9 vs. 10.7%, HR, 0.81, 95% CI 0.27–2.48, P = 0.71; TV-MI: 3.3 vs. 1.2%, HR, 2.39, 95% CI 0.27–21.32, P = 0.43) and BVS vs. EES (DOCE: 10.1 vs. 5.2% HR, 1.81, 95% CI, 0.63–5.25; P = 0.27; Cardiac death: 3.0 vs. 1.1%; HR, 2.83, 95% CI 0.29–27.4, P = 0.37; ID-TLR: 7.2 vs. 4.2%, HR, 1.57, 95% CI 0.47–5.23, P = 0.46; TV-MI: 3.1 vs. 0%). Conclusion: At 1-year follow-up the use of BVS as ISR treatment is associated with a higher, even if not significant, DOCE rate compared with EES while a similar rate compared to DEB. [/INST] Exclude </s>
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Mosquera 2016
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Drug-eluting stents remain the golden standard for below-the-knee occlusive disease
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Peripheral arterial disease (PAD) is a chronic condition; an increasing number of patients affected. Infrapopliteal disease is related to critical limb ischemia (CLI). Amputation-free survival in these situations is the goal to achieve; it is well-known that life expectancy and quality of live are reduced by this condition. PAD is rarely isolated in one anatomical region when a CLI condition exists. The endovascular approach to lower limb infrapopliteal disease (BTK) has been constantly increasing in the last years trying to prevent a potential amputation. Even with the current endovascular armamentarium, BTK disease remains challenging, long and even midterm results remain uncertain. The rationale behind using drug-eluting stent (DES) at BTK is similar to other regions; deal with elastic recoil, treat potential dissections, deliver drug to the intima to prevent restenosis and reduce late lumen loss. Current evidence comprehensive review of the latest published results has been performed as well a comparison with other available reviews and meta-analyses. There is an increasing evidence for the use of DES in BTK disease, multiple platforms with different drugs had been evaluated and some good initial results had been published and presented recently. The safety of DES used in BTK occlusive has been clearly proven over the different studies performed in the last years. Good primary patency has been reported for balloon expandable DES but available studies focused on short/focal lesions. Current results support the use of DES in BTK region when a stent is necessary (bail-out) or the total lesion length is short. There is a clear benefit for primary patency, potential clinical benefits and, under these conditions, DES treatment seems to be cost-effective. Further investigation and technology improvement is required to apply these good results to longer and more diffuse lesions.
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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: Drug-eluting stents remain the golden standard for below-the-knee occlusive disease ###Abstract: Peripheral arterial disease (PAD) is a chronic condition; an increasing number of patients affected. Infrapopliteal disease is related to critical limb ischemia (CLI). Amputation-free survival in these situations is the goal to achieve; it is well-known that life expectancy and quality of live are reduced by this condition. PAD is rarely isolated in one anatomical region when a CLI condition exists. The endovascular approach to lower limb infrapopliteal disease (BTK) has been constantly increasing in the last years trying to prevent a potential amputation. Even with the current endovascular armamentarium, BTK disease remains challenging, long and even midterm results remain uncertain. The rationale behind using drug-eluting stent (DES) at BTK is similar to other regions; deal with elastic recoil, treat potential dissections, deliver drug to the intima to prevent restenosis and reduce late lumen loss. Current evidence comprehensive review of the latest published results has been performed as well a comparison with other available reviews and meta-analyses. There is an increasing evidence for the use of DES in BTK disease, multiple platforms with different drugs had been evaluated and some good initial results had been published and presented recently. The safety of DES used in BTK occlusive has been clearly proven over the different studies performed in the last years. Good primary patency has been reported for balloon expandable DES but available studies focused on short/focal lesions. Current results support the use of DES in BTK region when a stent is necessary (bail-out) or the total lesion length is short. There is a clear benefit for primary patency, potential clinical benefits and, under these conditions, DES treatment seems to be cost-effective. Further investigation and technology improvement is required to apply these good results to longer and more diffuse 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: Drug-eluting stents remain the golden standard for below-the-knee occlusive disease ###Abstract: Peripheral arterial disease (PAD) is a chronic condition; an increasing number of patients affected. Infrapopliteal disease is related to critical limb ischemia (CLI). Amputation-free survival in these situations is the goal to achieve; it is well-known that life expectancy and quality of live are reduced by this condition. PAD is rarely isolated in one anatomical region when a CLI condition exists. The endovascular approach to lower limb infrapopliteal disease (BTK) has been constantly increasing in the last years trying to prevent a potential amputation. Even with the current endovascular armamentarium, BTK disease remains challenging, long and even midterm results remain uncertain. The rationale behind using drug-eluting stent (DES) at BTK is similar to other regions; deal with elastic recoil, treat potential dissections, deliver drug to the intima to prevent restenosis and reduce late lumen loss. Current evidence comprehensive review of the latest published results has been performed as well a comparison with other available reviews and meta-analyses. There is an increasing evidence for the use of DES in BTK disease, multiple platforms with different drugs had been evaluated and some good initial results had been published and presented recently. The safety of DES used in BTK occlusive has been clearly proven over the different studies performed in the last years. Good primary patency has been reported for balloon expandable DES but available studies focused on short/focal lesions. Current results support the use of DES in BTK region when a stent is necessary (bail-out) or the total lesion length is short. There is a clear benefit for primary patency, potential clinical benefits and, under these conditions, DES treatment seems to be cost-effective. Further investigation and technology improvement is required to apply these good results to longer and more diffuse lesions. [/INST] Exclude </s>
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Nagai 2020
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Acute and mid-term outcomes of drug-coated balloon following rotational atherectomy
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Rotational atherectomy (RA) is effective for reducing calcified plaque volume as part of percutaneous coronary intervention (PCI). Most lesions are then treated by stenting, but we often observe in-stent restenosis (ISR) due to an under-expanded stent associated with severe calcification, a condition that is particularly challenging to treat. It is unknown if drug-coated balloon (DCB) application following RA can be used as a “stentless” treatment strategy for calcified lesions. The aim of this study is to assess the acute and mid-term efficacy of DCB following RA (RA + DCB) at our institute and to evaluate the overall clinical utility of this stentless strategy for complex calcified lesions. From October 2014 to June 2018, 3644 lesions in 2424 consecutive cases were treated with PCI at our institute. Rotational atherectomy was used for 12.3% of all lesions and 42.3% of these RA-treated lesions were then treated using DCBs (n = 190 RA + DCB-treated lesions, of which 72% were in males). In-hospital major adverse cardiac events included only one case of non-Q-wave myocardial infarction. Average duration of follow-up coronary angiography after initial PCI was 199 ± 61 days. Angiographic restenosis was observed in 17.8% of RA + DCB-treated lesions, with mean late lumen loss of 0.23 ± 0.69 mm, while late lumen enlargement was observed in 39.1% of RA + DCB-treated lesions. At mid-term clinical follow-up, there were no cardiac deaths and target lesion revascularization rate was only 16.4%. Rotational atherectomy followed by DCB demonstrated acceptable acute and mid-term efficacy, suggesting that this stentless strategy may be an effective option for complex calcified lesions with high risk of ISR.
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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: Acute and mid-term outcomes of drug-coated balloon following rotational atherectomy ###Abstract: Rotational atherectomy (RA) is effective for reducing calcified plaque volume as part of percutaneous coronary intervention (PCI). Most lesions are then treated by stenting, but we often observe in-stent restenosis (ISR) due to an under-expanded stent associated with severe calcification, a condition that is particularly challenging to treat. It is unknown if drug-coated balloon (DCB) application following RA can be used as a “stentless” treatment strategy for calcified lesions. The aim of this study is to assess the acute and mid-term efficacy of DCB following RA (RA + DCB) at our institute and to evaluate the overall clinical utility of this stentless strategy for complex calcified lesions. From October 2014 to June 2018, 3644 lesions in 2424 consecutive cases were treated with PCI at our institute. Rotational atherectomy was used for 12.3% of all lesions and 42.3% of these RA-treated lesions were then treated using DCBs (n = 190 RA + DCB-treated lesions, of which 72% were in males). In-hospital major adverse cardiac events included only one case of non-Q-wave myocardial infarction. Average duration of follow-up coronary angiography after initial PCI was 199 ± 61 days. Angiographic restenosis was observed in 17.8% of RA + DCB-treated lesions, with mean late lumen loss of 0.23 ± 0.69 mm, while late lumen enlargement was observed in 39.1% of RA + DCB-treated lesions. At mid-term clinical follow-up, there were no cardiac deaths and target lesion revascularization rate was only 16.4%. Rotational atherectomy followed by DCB demonstrated acceptable acute and mid-term efficacy, suggesting that this stentless strategy may be an effective option for complex calcified lesions with high risk of 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: Acute and mid-term outcomes of drug-coated balloon following rotational atherectomy ###Abstract: Rotational atherectomy (RA) is effective for reducing calcified plaque volume as part of percutaneous coronary intervention (PCI). Most lesions are then treated by stenting, but we often observe in-stent restenosis (ISR) due to an under-expanded stent associated with severe calcification, a condition that is particularly challenging to treat. It is unknown if drug-coated balloon (DCB) application following RA can be used as a “stentless” treatment strategy for calcified lesions. The aim of this study is to assess the acute and mid-term efficacy of DCB following RA (RA + DCB) at our institute and to evaluate the overall clinical utility of this stentless strategy for complex calcified lesions. From October 2014 to June 2018, 3644 lesions in 2424 consecutive cases were treated with PCI at our institute. Rotational atherectomy was used for 12.3% of all lesions and 42.3% of these RA-treated lesions were then treated using DCBs (n = 190 RA + DCB-treated lesions, of which 72% were in males). In-hospital major adverse cardiac events included only one case of non-Q-wave myocardial infarction. Average duration of follow-up coronary angiography after initial PCI was 199 ± 61 days. Angiographic restenosis was observed in 17.8% of RA + DCB-treated lesions, with mean late lumen loss of 0.23 ± 0.69 mm, while late lumen enlargement was observed in 39.1% of RA + DCB-treated lesions. At mid-term clinical follow-up, there were no cardiac deaths and target lesion revascularization rate was only 16.4%. Rotational atherectomy followed by DCB demonstrated acceptable acute and mid-term efficacy, suggesting that this stentless strategy may be an effective option for complex calcified lesions with high risk of ISR. [/INST] Exclude </s>
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Nagamine 2019
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Rotational atherectomy for ablation of multiple channel structure observed by optical frequency domain imaging
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Objective: Unusual or unexpected effect of treatment Background: Previous case reports have shown that regardless of the etiology, multiple channel structures can be treated successfully by routine percutaneous coronary intervention. However, there are no general recommendations for intervention because multiple channel structures are complex and rarely diagnosed. Case Report: A 71-year-old male was admitted to our hospital due to bronchial pneumonia. After admission, the patient experienced acute decompensated heart failure. Coronary angiogram revealed 3 diseased vessels with heavy calcification. Although the patient’s syntax score was high, we performed percutaneous coronary intervention (PCI) on each vessel based on his request and in consideration of his dementia. After PCI for the left circumflex and descending arteries, we performed PCI for the right coronary artery (RCA) using optical frequency domain imaging (OFDI). A multiple channel structure and calcified nodule were observed by OFDI. We performed rotational atherectomy (RA) on the RCA, and the 2 structures were ablated. After RA, we dilated the lesions with a scoring balloon and deployed a drug-eluting stent. Conclusions: RA was effective in ablating partition walls of the multiple channel structure observed using OFDI.
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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: Rotational atherectomy for ablation of multiple channel structure observed by optical frequency domain imaging ###Abstract: Objective: Unusual or unexpected effect of treatment Background: Previous case reports have shown that regardless of the etiology, multiple channel structures can be treated successfully by routine percutaneous coronary intervention. However, there are no general recommendations for intervention because multiple channel structures are complex and rarely diagnosed. Case Report: A 71-year-old male was admitted to our hospital due to bronchial pneumonia. After admission, the patient experienced acute decompensated heart failure. Coronary angiogram revealed 3 diseased vessels with heavy calcification. Although the patient’s syntax score was high, we performed percutaneous coronary intervention (PCI) on each vessel based on his request and in consideration of his dementia. After PCI for the left circumflex and descending arteries, we performed PCI for the right coronary artery (RCA) using optical frequency domain imaging (OFDI). A multiple channel structure and calcified nodule were observed by OFDI. We performed rotational atherectomy (RA) on the RCA, and the 2 structures were ablated. After RA, we dilated the lesions with a scoring balloon and deployed a drug-eluting stent. Conclusions: RA was effective in ablating partition walls of the multiple channel structure observed using OFDI. [/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: Rotational atherectomy for ablation of multiple channel structure observed by optical frequency domain imaging ###Abstract: Objective: Unusual or unexpected effect of treatment Background: Previous case reports have shown that regardless of the etiology, multiple channel structures can be treated successfully by routine percutaneous coronary intervention. However, there are no general recommendations for intervention because multiple channel structures are complex and rarely diagnosed. Case Report: A 71-year-old male was admitted to our hospital due to bronchial pneumonia. After admission, the patient experienced acute decompensated heart failure. Coronary angiogram revealed 3 diseased vessels with heavy calcification. Although the patient’s syntax score was high, we performed percutaneous coronary intervention (PCI) on each vessel based on his request and in consideration of his dementia. After PCI for the left circumflex and descending arteries, we performed PCI for the right coronary artery (RCA) using optical frequency domain imaging (OFDI). A multiple channel structure and calcified nodule were observed by OFDI. We performed rotational atherectomy (RA) on the RCA, and the 2 structures were ablated. After RA, we dilated the lesions with a scoring balloon and deployed a drug-eluting stent. Conclusions: RA was effective in ablating partition walls of the multiple channel structure observed using OFDI. [/INST] Exclude </s>
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Naganuma 2016
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Drug-eluting balloon versus second-generation drug-eluting stent for the treatment of restenotic lesions involving coronary bifurcations
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Aims: To report clinical outcomes in patients treated with drug-eluting balloon (DEB) versus second-generation drug-eluting stent (DES) for in-stent restenosis (ISR) involving a bifurcation lesion. Methods and results: Between February 2007 and November 2012, 167 bifurcation restenoses in 158 patients were treated with either DEB (n=73) or second-generation DES (n=85). The EuroSCORE was significantly higher in the DEB group (4.2±3.8 vs. 2.8±2.1, p=0.004). Regarding restenosed stent type, second- generation DES was more frequently seen in the DEB group (26.9% vs. 6.7%, p<0.001). In this group, there was also a trend towards more frequent stenting for a previous ISR (stent-in-stent) as compared with the DES group (25.6% vs. 15.6%, p=0.074). Over a median follow-up period of 701 days, there was no significant difference in major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction including periprocedural myocardial infarction, target vessel revascularisation, between the two groups (p=0.585). Independent predictors of MACE on multivariate Cox regression analysis included stent-in-stent (HR: 2.16; 95% CI: 1.11 to 4.20; p=0.023) and true bifurcation lesions (HR: 2.98; 95% CI: 1.45 to 6.14; p=0.001). Conclusions: DEB for bifurcation restenosis may be an acceptable treatment option, especially in cases where repeat stenting has not already been performed for the treatment of a previous restenosis.
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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: Drug-eluting balloon versus second-generation drug-eluting stent for the treatment of restenotic lesions involving coronary bifurcations ###Abstract: Aims: To report clinical outcomes in patients treated with drug-eluting balloon (DEB) versus second-generation drug-eluting stent (DES) for in-stent restenosis (ISR) involving a bifurcation lesion. Methods and results: Between February 2007 and November 2012, 167 bifurcation restenoses in 158 patients were treated with either DEB (n=73) or second-generation DES (n=85). The EuroSCORE was significantly higher in the DEB group (4.2±3.8 vs. 2.8±2.1, p=0.004). Regarding restenosed stent type, second- generation DES was more frequently seen in the DEB group (26.9% vs. 6.7%, p<0.001). In this group, there was also a trend towards more frequent stenting for a previous ISR (stent-in-stent) as compared with the DES group (25.6% vs. 15.6%, p=0.074). Over a median follow-up period of 701 days, there was no significant difference in major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction including periprocedural myocardial infarction, target vessel revascularisation, between the two groups (p=0.585). Independent predictors of MACE on multivariate Cox regression analysis included stent-in-stent (HR: 2.16; 95% CI: 1.11 to 4.20; p=0.023) and true bifurcation lesions (HR: 2.98; 95% CI: 1.45 to 6.14; p=0.001). Conclusions: DEB for bifurcation restenosis may be an acceptable treatment option, especially in cases where repeat stenting has not already been performed for the treatment of a previous restenosis. [/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 versus second-generation drug-eluting stent for the treatment of restenotic lesions involving coronary bifurcations ###Abstract: Aims: To report clinical outcomes in patients treated with drug-eluting balloon (DEB) versus second-generation drug-eluting stent (DES) for in-stent restenosis (ISR) involving a bifurcation lesion. Methods and results: Between February 2007 and November 2012, 167 bifurcation restenoses in 158 patients were treated with either DEB (n=73) or second-generation DES (n=85). The EuroSCORE was significantly higher in the DEB group (4.2±3.8 vs. 2.8±2.1, p=0.004). Regarding restenosed stent type, second- generation DES was more frequently seen in the DEB group (26.9% vs. 6.7%, p<0.001). In this group, there was also a trend towards more frequent stenting for a previous ISR (stent-in-stent) as compared with the DES group (25.6% vs. 15.6%, p=0.074). Over a median follow-up period of 701 days, there was no significant difference in major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction including periprocedural myocardial infarction, target vessel revascularisation, between the two groups (p=0.585). Independent predictors of MACE on multivariate Cox regression analysis included stent-in-stent (HR: 2.16; 95% CI: 1.11 to 4.20; p=0.023) and true bifurcation lesions (HR: 2.98; 95% CI: 1.45 to 6.14; p=0.001). Conclusions: DEB for bifurcation restenosis may be an acceptable treatment option, especially in cases where repeat stenting has not already been performed for the treatment of a previous restenosis. [/INST] Exclude </s>
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Nakama 2017
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Novel retrograde puncture technique for infrapopliteal artery revascularization: transplantar retrograde access
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Patients with critical limbs ischemia received endovascular revascularization for his posterior tibial artery (PTA) to plantar artery long occlusion without proximal stump. Antegrade recanalization seemed impossible, so retrograde access should be considered. However, the conventional retrograde puncture was also not available. Therefore, novel retrograde transplantar access was conducted. The plantar artery was successfully punctured with a 20-G needle. In addition, a guidewire was retrogradely inserted with a sheathless technique. Finally, it was retrogradely crossed the occluded lesion. The final angiogram showed sufficient results. Transplantar retrograde access was feasible technique for infrapopliteal EVT, when the conventional antegrade and retrograde approaches were not available.
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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: Novel retrograde puncture technique for infrapopliteal artery revascularization: transplantar retrograde access ###Abstract: Patients with critical limbs ischemia received endovascular revascularization for his posterior tibial artery (PTA) to plantar artery long occlusion without proximal stump. Antegrade recanalization seemed impossible, so retrograde access should be considered. However, the conventional retrograde puncture was also not available. Therefore, novel retrograde transplantar access was conducted. The plantar artery was successfully punctured with a 20-G needle. In addition, a guidewire was retrogradely inserted with a sheathless technique. Finally, it was retrogradely crossed the occluded lesion. The final angiogram showed sufficient results. Transplantar retrograde access was feasible technique for infrapopliteal EVT, when the conventional antegrade and retrograde approaches were not available. [/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: Novel retrograde puncture technique for infrapopliteal artery revascularization: transplantar retrograde access ###Abstract: Patients with critical limbs ischemia received endovascular revascularization for his posterior tibial artery (PTA) to plantar artery long occlusion without proximal stump. Antegrade recanalization seemed impossible, so retrograde access should be considered. However, the conventional retrograde puncture was also not available. Therefore, novel retrograde transplantar access was conducted. The plantar artery was successfully punctured with a 20-G needle. In addition, a guidewire was retrogradely inserted with a sheathless technique. Finally, it was retrogradely crossed the occluded lesion. The final angiogram showed sufficient results. Transplantar retrograde access was feasible technique for infrapopliteal EVT, when the conventional antegrade and retrograde approaches were not available. [/INST] Exclude </s>
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Nakama 2020
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Intravascular Ultrasound Findings after Successful Guidewire Passage With a Retrograde Narrowing Looped Wire Technique
| null |
Exclude
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DE9 - Unavailable
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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: Intravascular Ultrasound Findings after Successful Guidewire Passage With a Retrograde Narrowing Looped Wire Technique ###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: Intravascular Ultrasound Findings after Successful Guidewire Passage With a Retrograde Narrowing Looped Wire Technique ###Abstract: None [/INST] Exclude </s>
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Nestelberger 2019
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Drug-coated Balloons for Small Coronary Vessel Interventions: A literature review
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Newer-generation drug-eluting stents (DES) are the standard of care for the treatment of symptomatic coronary artery disease. However, some lack of efficacy has been reported in small coronary arteries based on higher rates of target lesion restenosis, thrombosis and MI resulting in repeated interventions. Drug-coated balloons (DCBs) are an established treatment option for in-stent restenosis in both bare metal stents and DES and they can deliver an anti-proliferative drug into the vessel wall without implanting a stent. DCBs are a promising technique for selected de novo coronary lesions, especially in small vessel disease. In this article, the current evidence for the treatment of small vessel disease with DCBs will be reviewed.
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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: Drug-coated Balloons for Small Coronary Vessel Interventions: A literature review ###Abstract: Newer-generation drug-eluting stents (DES) are the standard of care for the treatment of symptomatic coronary artery disease. However, some lack of efficacy has been reported in small coronary arteries based on higher rates of target lesion restenosis, thrombosis and MI resulting in repeated interventions. Drug-coated balloons (DCBs) are an established treatment option for in-stent restenosis in both bare metal stents and DES and they can deliver an anti-proliferative drug into the vessel wall without implanting a stent. DCBs are a promising technique for selected de novo coronary lesions, especially in small vessel disease. In this article, the current evidence for the treatment of small vessel disease with DCBs will be reviewed. [/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 Small Coronary Vessel Interventions: A literature review ###Abstract: Newer-generation drug-eluting stents (DES) are the standard of care for the treatment of symptomatic coronary artery disease. However, some lack of efficacy has been reported in small coronary arteries based on higher rates of target lesion restenosis, thrombosis and MI resulting in repeated interventions. Drug-coated balloons (DCBs) are an established treatment option for in-stent restenosis in both bare metal stents and DES and they can deliver an anti-proliferative drug into the vessel wall without implanting a stent. DCBs are a promising technique for selected de novo coronary lesions, especially in small vessel disease. In this article, the current evidence for the treatment of small vessel disease with DCBs will be reviewed. [/INST] Exclude </s>
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Nijhoff 2016
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Comparative assessment of the antirestenotic efficacy of two paclitaxel drug-eluting balloons with different coatings in the treatment of in-stent restenosis
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Background/objectives: Preclinical investigations have suggested that coating technology is crucial for the efficacy of drug-eluting balloons (DEB). Aim of this study is to compare the antirestenotic efficacy of two paclitaxel DEB with different coatings in the treatment of in-stent restenosis (ISR) by means of a morphological and functional assessment. Methods: In a single center, prospective, non-randomized study, the shellac-paclitaxel coated DIOR, and the urea-paclitaxel coated IN.PACT Falcon were compared in the setting of ISR. Quantitative angiography, fractional flow reserve (FFR), and optical coherence tomography (OCT) were performed at baseline, postprocedure and 6-month follow-up. Main endpoints were QCA, FFR and OCT-based parameters of restenosis. Results: Forty-five patients were included, 20 (44 %) received treatment with the DIOR and 25 (56 %) with the IN.PACT Falcon. Angiographic and device success were 100 and 90 % for the DIOR, and 100 and 92 % for the IN.PACT Falcon, respectively. After 6-months, in-segment late lumen loss (−0.03 ± 0.43 vs. 0.36 ± 0.48 mm, p = 0.014) and diameter stenosis (30.7 ± 16.2 vs. 41.3 ± 22.6 %, p = 0.083) were lower for the IN.PACT Falcon. FFR distal of the stent was significantly higher in the IN.PACT Falcon group (0.92 ± 0.07 vs. 0.84 ± 0.13, p = 0.029) and in-stent FFR gradient was lower (0.05 ± 0.05 vs. 0.13 ± 0.12, p = 0.002). Between postprocedure and follow-up, a 16 % decrease in neointimal volume was observed for the IN.PACT Falcon, while a 30 % increase was observed for the DIOR (p = 0.006). Conclusions: The IN.PACT Falcon DEB showed higher antirestenotic efficacy than the DIOR in the treatment of ISR, demonstrating that DEB with an excipient-based coating is not equally effective.
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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: Comparative assessment of the antirestenotic efficacy of two paclitaxel drug-eluting balloons with different coatings in the treatment of in-stent restenosis ###Abstract: Background/objectives: Preclinical investigations have suggested that coating technology is crucial for the efficacy of drug-eluting balloons (DEB). Aim of this study is to compare the antirestenotic efficacy of two paclitaxel DEB with different coatings in the treatment of in-stent restenosis (ISR) by means of a morphological and functional assessment. Methods: In a single center, prospective, non-randomized study, the shellac-paclitaxel coated DIOR, and the urea-paclitaxel coated IN.PACT Falcon were compared in the setting of ISR. Quantitative angiography, fractional flow reserve (FFR), and optical coherence tomography (OCT) were performed at baseline, postprocedure and 6-month follow-up. Main endpoints were QCA, FFR and OCT-based parameters of restenosis. Results: Forty-five patients were included, 20 (44 %) received treatment with the DIOR and 25 (56 %) with the IN.PACT Falcon. Angiographic and device success were 100 and 90 % for the DIOR, and 100 and 92 % for the IN.PACT Falcon, respectively. After 6-months, in-segment late lumen loss (−0.03 ± 0.43 vs. 0.36 ± 0.48 mm, p = 0.014) and diameter stenosis (30.7 ± 16.2 vs. 41.3 ± 22.6 %, p = 0.083) were lower for the IN.PACT Falcon. FFR distal of the stent was significantly higher in the IN.PACT Falcon group (0.92 ± 0.07 vs. 0.84 ± 0.13, p = 0.029) and in-stent FFR gradient was lower (0.05 ± 0.05 vs. 0.13 ± 0.12, p = 0.002). Between postprocedure and follow-up, a 16 % decrease in neointimal volume was observed for the IN.PACT Falcon, while a 30 % increase was observed for the DIOR (p = 0.006). Conclusions: The IN.PACT Falcon DEB showed higher antirestenotic efficacy than the DIOR in the treatment of ISR, demonstrating that DEB with an excipient-based coating is not equally effective. [/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 assessment of the antirestenotic efficacy of two paclitaxel drug-eluting balloons with different coatings in the treatment of in-stent restenosis ###Abstract: Background/objectives: Preclinical investigations have suggested that coating technology is crucial for the efficacy of drug-eluting balloons (DEB). Aim of this study is to compare the antirestenotic efficacy of two paclitaxel DEB with different coatings in the treatment of in-stent restenosis (ISR) by means of a morphological and functional assessment. Methods: In a single center, prospective, non-randomized study, the shellac-paclitaxel coated DIOR, and the urea-paclitaxel coated IN.PACT Falcon were compared in the setting of ISR. Quantitative angiography, fractional flow reserve (FFR), and optical coherence tomography (OCT) were performed at baseline, postprocedure and 6-month follow-up. Main endpoints were QCA, FFR and OCT-based parameters of restenosis. Results: Forty-five patients were included, 20 (44 %) received treatment with the DIOR and 25 (56 %) with the IN.PACT Falcon. Angiographic and device success were 100 and 90 % for the DIOR, and 100 and 92 % for the IN.PACT Falcon, respectively. After 6-months, in-segment late lumen loss (−0.03 ± 0.43 vs. 0.36 ± 0.48 mm, p = 0.014) and diameter stenosis (30.7 ± 16.2 vs. 41.3 ± 22.6 %, p = 0.083) were lower for the IN.PACT Falcon. FFR distal of the stent was significantly higher in the IN.PACT Falcon group (0.92 ± 0.07 vs. 0.84 ± 0.13, p = 0.029) and in-stent FFR gradient was lower (0.05 ± 0.05 vs. 0.13 ± 0.12, p = 0.002). Between postprocedure and follow-up, a 16 % decrease in neointimal volume was observed for the IN.PACT Falcon, while a 30 % increase was observed for the DIOR (p = 0.006). Conclusions: The IN.PACT Falcon DEB showed higher antirestenotic efficacy than the DIOR in the treatment of ISR, demonstrating that DEB with an excipient-based coating is not equally effective. [/INST] Exclude </s>
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Ohno 2016
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Repetitive stent thrombosis in a patient who had resistance to both clopidogrel and prasugrel
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Clopidogrel resistance is associated with stent thrombosis. Prasugrel achieves greater platelet inhibition with less variability among patients than does clopidogrel. Thus, a patient who had stent thrombosis due to clopidogrel resistance may receive prasugrel to prevent repeated episodes of stent thrombosis. This case report describes a case of repetitive stent thrombosis in which resistance not only to clopidogrel, but also to prasugrel, was observed. Learning objective: In the face of clopidogrel resistance, prescribing prasugrel may be an acceptable treatment option. However, cross-unresponsiveness may be observed between clopidogrel and prasugrel. Thus, platelet function assay should be performed in patients with stent thrombosis, even when clopidogrel is replaced with prasugrel.
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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: Repetitive stent thrombosis in a patient who had resistance to both clopidogrel and prasugrel ###Abstract: Clopidogrel resistance is associated with stent thrombosis. Prasugrel achieves greater platelet inhibition with less variability among patients than does clopidogrel. Thus, a patient who had stent thrombosis due to clopidogrel resistance may receive prasugrel to prevent repeated episodes of stent thrombosis. This case report describes a case of repetitive stent thrombosis in which resistance not only to clopidogrel, but also to prasugrel, was observed. Learning objective: In the face of clopidogrel resistance, prescribing prasugrel may be an acceptable treatment option. However, cross-unresponsiveness may be observed between clopidogrel and prasugrel. Thus, platelet function assay should be performed in patients with stent thrombosis, even when clopidogrel is replaced with prasugrel. [/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: Repetitive stent thrombosis in a patient who had resistance to both clopidogrel and prasugrel ###Abstract: Clopidogrel resistance is associated with stent thrombosis. Prasugrel achieves greater platelet inhibition with less variability among patients than does clopidogrel. Thus, a patient who had stent thrombosis due to clopidogrel resistance may receive prasugrel to prevent repeated episodes of stent thrombosis. This case report describes a case of repetitive stent thrombosis in which resistance not only to clopidogrel, but also to prasugrel, was observed. Learning objective: In the face of clopidogrel resistance, prescribing prasugrel may be an acceptable treatment option. However, cross-unresponsiveness may be observed between clopidogrel and prasugrel. Thus, platelet function assay should be performed in patients with stent thrombosis, even when clopidogrel is replaced with prasugrel. [/INST] Exclude </s>
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Oka 2020
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An autopsy case report of extensive intramyocardial hemorrhage complicated with acute myocardial infarction
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Hemorrhagic myocardial infarction (HMI) is a complication associated with percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). We carried out a successful PCI for a 59-year old Japanese man presenting with chest pain due to AMI over 5 h. The onset to balloon time was 363 min. The next morning, he suffered cardiogenic shock, even with an auxiliary circulating device, which eventually resulted in death. An autopsy revealed extensive HMI. The necrotic myocardium showed not only coagulation necrosis but also contraction band necrosis which suggests myocardial injury due to late reperfusion. Although the intramyocardial hemorrhage was confined to the necrotic area, it was beyond the perfusion area of the culprit artery. Here, we describe a case of death with severe HMI. HMI can be a serious complication and worsen prognosis. <Learning objective: The aim of primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) is to recanalize the infarct related artery and salvage the ischemic myocardium. However, late reperfusion sometimes leads to hemorrhagic myocardial infarction (HMI) as a result of myocardial injury. To avoid extensive HMI in AMI patients, primary PCI should be performed as soon as possible.>
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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: An autopsy case report of extensive intramyocardial hemorrhage complicated with acute myocardial infarction ###Abstract: Hemorrhagic myocardial infarction (HMI) is a complication associated with percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). We carried out a successful PCI for a 59-year old Japanese man presenting with chest pain due to AMI over 5 h. The onset to balloon time was 363 min. The next morning, he suffered cardiogenic shock, even with an auxiliary circulating device, which eventually resulted in death. An autopsy revealed extensive HMI. The necrotic myocardium showed not only coagulation necrosis but also contraction band necrosis which suggests myocardial injury due to late reperfusion. Although the intramyocardial hemorrhage was confined to the necrotic area, it was beyond the perfusion area of the culprit artery. Here, we describe a case of death with severe HMI. HMI can be a serious complication and worsen prognosis. <Learning objective: The aim of primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) is to recanalize the infarct related artery and salvage the ischemic myocardium. However, late reperfusion sometimes leads to hemorrhagic myocardial infarction (HMI) as a result of myocardial injury. To avoid extensive HMI in AMI patients, primary PCI should be performed as soon as possible.> [/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: An autopsy case report of extensive intramyocardial hemorrhage complicated with acute myocardial infarction ###Abstract: Hemorrhagic myocardial infarction (HMI) is a complication associated with percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). We carried out a successful PCI for a 59-year old Japanese man presenting with chest pain due to AMI over 5 h. The onset to balloon time was 363 min. The next morning, he suffered cardiogenic shock, even with an auxiliary circulating device, which eventually resulted in death. An autopsy revealed extensive HMI. The necrotic myocardium showed not only coagulation necrosis but also contraction band necrosis which suggests myocardial injury due to late reperfusion. Although the intramyocardial hemorrhage was confined to the necrotic area, it was beyond the perfusion area of the culprit artery. Here, we describe a case of death with severe HMI. HMI can be a serious complication and worsen prognosis. <Learning objective: The aim of primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) is to recanalize the infarct related artery and salvage the ischemic myocardium. However, late reperfusion sometimes leads to hemorrhagic myocardial infarction (HMI) as a result of myocardial injury. To avoid extensive HMI in AMI patients, primary PCI should be performed as soon as possible.> [/INST] Exclude </s>
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Otsuka 2017
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Prolonged inflation technique using a scoring balloon for severe calcified lesion: Creep phenomenon
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Percutaneous coronary intervention for the treatment of a severe calcified lesion is still one of the most technically challenging areas of interventional cardiology. Calcified lesions are a cause of stent underexpansion, which significantly increases the subsequent risks of in-stent restenosis and thrombosis, even when drug-eluting stents are used. In this report, we describe the usefulness of prolonged inflations using a scoring balloon catheter (Scoreflex) for severe calcified lesions. Prolonged inflation using a scoring balloon enables an adequate dilation for treatment of a severe calcified plaque that was unresponsive to conventional technique with or without rotational atherectomy.
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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: Prolonged inflation technique using a scoring balloon for severe calcified lesion: Creep phenomenon ###Abstract: Percutaneous coronary intervention for the treatment of a severe calcified lesion is still one of the most technically challenging areas of interventional cardiology. Calcified lesions are a cause of stent underexpansion, which significantly increases the subsequent risks of in-stent restenosis and thrombosis, even when drug-eluting stents are used. In this report, we describe the usefulness of prolonged inflations using a scoring balloon catheter (Scoreflex) for severe calcified lesions. Prolonged inflation using a scoring balloon enables an adequate dilation for treatment of a severe calcified plaque that was unresponsive to conventional technique with or without rotational atherectomy. [/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: Prolonged inflation technique using a scoring balloon for severe calcified lesion: Creep phenomenon ###Abstract: Percutaneous coronary intervention for the treatment of a severe calcified lesion is still one of the most technically challenging areas of interventional cardiology. Calcified lesions are a cause of stent underexpansion, which significantly increases the subsequent risks of in-stent restenosis and thrombosis, even when drug-eluting stents are used. In this report, we describe the usefulness of prolonged inflations using a scoring balloon catheter (Scoreflex) for severe calcified lesions. Prolonged inflation using a scoring balloon enables an adequate dilation for treatment of a severe calcified plaque that was unresponsive to conventional technique with or without rotational atherectomy. [/INST] Exclude </s>
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Oz 2016
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Comparison of Drug-Eluting Balloon and Standard Balloon Angioplasty for Infrapopliteal Arterial Diseases in Diabetic Patients
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Objective: To consider the clinical outcomes and restenosis rates of drug-eluting balloons (DEBs) and percutaneous transluminal angioplasty (PTA) in diabetic patients with infrapopliteal (IP) arterial disease. Materials and Methods: This retrospective, single-center study included 51 patients (37 males; mean age: 63.43 ± 9.81 years) with diabetes mellitus having IP arterial disease, from October 2012 to September 2014. Twenty-two patients were treated with PTA, and 29 patients were treated with DEBs. After intervention, the patients were evaluated in the first week and every 3 months, clinically and radiologically. Univariate and multivariate analyses were used to evaluate the clinical outcomes of diabetic patients with IP arterial disease who were treated with either DEBs or PTA. Results: There were no statistically significant differences between the groups in terms of age and gender, risk factors, characteristics of lesions, or the diameters or length of the balloons (P >.05). Primary patency was higher in the DEB group than in the PTA group (97.8% vs 81.1%, P =.020) in the first 3 months. However, there was no statistically significant difference at 1-year follow-up (68.2% vs 48.5%, P =.131). At the 12-month follow-up, there was no difference in clinical improvement between the groups (P =.193). Conclusion: The findings of this study reveal that DEB is a safe alternative treatment method for IP arterial disease in diabetic patients.
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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: Comparison of Drug-Eluting Balloon and Standard Balloon Angioplasty for Infrapopliteal Arterial Diseases in Diabetic Patients ###Abstract: Objective: To consider the clinical outcomes and restenosis rates of drug-eluting balloons (DEBs) and percutaneous transluminal angioplasty (PTA) in diabetic patients with infrapopliteal (IP) arterial disease. Materials and Methods: This retrospective, single-center study included 51 patients (37 males; mean age: 63.43 ± 9.81 years) with diabetes mellitus having IP arterial disease, from October 2012 to September 2014. Twenty-two patients were treated with PTA, and 29 patients were treated with DEBs. After intervention, the patients were evaluated in the first week and every 3 months, clinically and radiologically. Univariate and multivariate analyses were used to evaluate the clinical outcomes of diabetic patients with IP arterial disease who were treated with either DEBs or PTA. Results: There were no statistically significant differences between the groups in terms of age and gender, risk factors, characteristics of lesions, or the diameters or length of the balloons (P >.05). Primary patency was higher in the DEB group than in the PTA group (97.8% vs 81.1%, P =.020) in the first 3 months. However, there was no statistically significant difference at 1-year follow-up (68.2% vs 48.5%, P =.131). At the 12-month follow-up, there was no difference in clinical improvement between the groups (P =.193). Conclusion: The findings of this study reveal that DEB is a safe alternative treatment method for IP arterial disease in diabetic 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: Comparison of Drug-Eluting Balloon and Standard Balloon Angioplasty for Infrapopliteal Arterial Diseases in Diabetic Patients ###Abstract: Objective: To consider the clinical outcomes and restenosis rates of drug-eluting balloons (DEBs) and percutaneous transluminal angioplasty (PTA) in diabetic patients with infrapopliteal (IP) arterial disease. Materials and Methods: This retrospective, single-center study included 51 patients (37 males; mean age: 63.43 ± 9.81 years) with diabetes mellitus having IP arterial disease, from October 2012 to September 2014. Twenty-two patients were treated with PTA, and 29 patients were treated with DEBs. After intervention, the patients were evaluated in the first week and every 3 months, clinically and radiologically. Univariate and multivariate analyses were used to evaluate the clinical outcomes of diabetic patients with IP arterial disease who were treated with either DEBs or PTA. Results: There were no statistically significant differences between the groups in terms of age and gender, risk factors, characteristics of lesions, or the diameters or length of the balloons (P >.05). Primary patency was higher in the DEB group than in the PTA group (97.8% vs 81.1%, P =.020) in the first 3 months. However, there was no statistically significant difference at 1-year follow-up (68.2% vs 48.5%, P =.131). At the 12-month follow-up, there was no difference in clinical improvement between the groups (P =.193). Conclusion: The findings of this study reveal that DEB is a safe alternative treatment method for IP arterial disease in diabetic patients. [/INST] Exclude </s>
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Patel 2020
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The Medical and Endovascular Treatment of PAD: A Review of the Guidelines and Pivotal Clinical Trials
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Peripheral arterial disease (PAD) is a global health problem. The risk factors for developing PAD have been clearly described in the literature, as have the medical therapies and preventative strategies for the prevention and treatment of PAD. Unfortunately, PAD patients remain undertreated with regard to guideline-directed medical therapy. During the last 2 decades, endovascular therapies for PAD have evolved such that randomized controlled trial level data are available for the treatment of lower extremity PAD at every major anatomic segment. Furthermore, endovascular therapy has evolved to the point that among experienced operators, an endovascular first strategy is reasonable for the treatment of most patients with intermittent claudication or critical limb ischemia.
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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: The Medical and Endovascular Treatment of PAD: A Review of the Guidelines and Pivotal Clinical Trials ###Abstract: Peripheral arterial disease (PAD) is a global health problem. The risk factors for developing PAD have been clearly described in the literature, as have the medical therapies and preventative strategies for the prevention and treatment of PAD. Unfortunately, PAD patients remain undertreated with regard to guideline-directed medical therapy. During the last 2 decades, endovascular therapies for PAD have evolved such that randomized controlled trial level data are available for the treatment of lower extremity PAD at every major anatomic segment. Furthermore, endovascular therapy has evolved to the point that among experienced operators, an endovascular first strategy is reasonable for the treatment of most patients with intermittent claudication or critical limb ischemia. [/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 Medical and Endovascular Treatment of PAD: A Review of the Guidelines and Pivotal Clinical Trials ###Abstract: Peripheral arterial disease (PAD) is a global health problem. The risk factors for developing PAD have been clearly described in the literature, as have the medical therapies and preventative strategies for the prevention and treatment of PAD. Unfortunately, PAD patients remain undertreated with regard to guideline-directed medical therapy. During the last 2 decades, endovascular therapies for PAD have evolved such that randomized controlled trial level data are available for the treatment of lower extremity PAD at every major anatomic segment. Furthermore, endovascular therapy has evolved to the point that among experienced operators, an endovascular first strategy is reasonable for the treatment of most patients with intermittent claudication or critical limb ischemia. [/INST] Exclude </s>
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Perisic 2020
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Diagnosis and percutaneous coronary intervention of an anomalous right coronary artery originating from the middle of the left anterior descending artery: a case report
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A single left coronary artery is a very rare anomaly in which only the left coronary artery arises from the aortic trunk by a single coronary ostium and supplies the entire heart. The present report is one of the few describing a patient with an anomalous right coronary artery originating from the middle of the left anterior descending artery. The patient presented with acute myocardial infarction with the culprit lesion on the left circumflex artery. Multivessel angioplasty was successfully performed in a two-step approach: the first for the culprit lesion and the second on the anomalous coronary artery. Decisions about treatment modalities for an anomalous coronary artery should be made only after considering the patient’s clinical characteristics and performing additional imaging diagnostics with a clearly defined coronary anatomy.
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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: Diagnosis and percutaneous coronary intervention of an anomalous right coronary artery originating from the middle of the left anterior descending artery: a case report ###Abstract: A single left coronary artery is a very rare anomaly in which only the left coronary artery arises from the aortic trunk by a single coronary ostium and supplies the entire heart. The present report is one of the few describing a patient with an anomalous right coronary artery originating from the middle of the left anterior descending artery. The patient presented with acute myocardial infarction with the culprit lesion on the left circumflex artery. Multivessel angioplasty was successfully performed in a two-step approach: the first for the culprit lesion and the second on the anomalous coronary artery. Decisions about treatment modalities for an anomalous coronary artery should be made only after considering the patient’s clinical characteristics and performing additional imaging diagnostics with a clearly defined coronary anatomy. [/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: Diagnosis and percutaneous coronary intervention of an anomalous right coronary artery originating from the middle of the left anterior descending artery: a case report ###Abstract: A single left coronary artery is a very rare anomaly in which only the left coronary artery arises from the aortic trunk by a single coronary ostium and supplies the entire heart. The present report is one of the few describing a patient with an anomalous right coronary artery originating from the middle of the left anterior descending artery. The patient presented with acute myocardial infarction with the culprit lesion on the left circumflex artery. Multivessel angioplasty was successfully performed in a two-step approach: the first for the culprit lesion and the second on the anomalous coronary artery. Decisions about treatment modalities for an anomalous coronary artery should be made only after considering the patient’s clinical characteristics and performing additional imaging diagnostics with a clearly defined coronary anatomy. [/INST] Exclude </s>
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Peterson 2017
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IN.PACT™ Admiral™ drug-coated balloon: Durable, consistent and safe treatment for femoropopliteal peripheral artery disease
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Endovascular management of peripheral artery disease was until recently limited to percutaneous balloon angioplasty, atherectomy, stent grafts, and bare-metal stents. These therapies have been valuable, but plagued by high restenosis and revascularization rates. Important progress has been made with the introduction of combination devices, including drug-eluting stents and drug-coated balloons (DCB), designed to combat restenosis by locally delivering anti-proliferative drugs. In particular, promising clinical performance has been seen with the Medtronic IN.PACT™ Admiral™ DCB, with durable, consistent and safe results. Rigorous, randomized controlled trials have directly compared this and other drug-delivering devices to their non-drug-coated counterparts with data available through two years. Additionally, trials are ongoing to assess use of drug-coated technologies in combination with traditional therapies in hope of synergistic effects. This review gathers data from currently published clinical trials with the IN.PACT Admiral DCB for the treatment of femoropopliteal peripheral artery disease and explores the possible impact on continuing clinical practice.
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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: IN.PACT™ Admiral™ drug-coated balloon: Durable, consistent and safe treatment for femoropopliteal peripheral artery disease ###Abstract: Endovascular management of peripheral artery disease was until recently limited to percutaneous balloon angioplasty, atherectomy, stent grafts, and bare-metal stents. These therapies have been valuable, but plagued by high restenosis and revascularization rates. Important progress has been made with the introduction of combination devices, including drug-eluting stents and drug-coated balloons (DCB), designed to combat restenosis by locally delivering anti-proliferative drugs. In particular, promising clinical performance has been seen with the Medtronic IN.PACT™ Admiral™ DCB, with durable, consistent and safe results. Rigorous, randomized controlled trials have directly compared this and other drug-delivering devices to their non-drug-coated counterparts with data available through two years. Additionally, trials are ongoing to assess use of drug-coated technologies in combination with traditional therapies in hope of synergistic effects. This review gathers data from currently published clinical trials with the IN.PACT Admiral DCB for the treatment of femoropopliteal peripheral artery disease and explores the possible impact on continuing clinical 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: IN.PACT™ Admiral™ drug-coated balloon: Durable, consistent and safe treatment for femoropopliteal peripheral artery disease ###Abstract: Endovascular management of peripheral artery disease was until recently limited to percutaneous balloon angioplasty, atherectomy, stent grafts, and bare-metal stents. These therapies have been valuable, but plagued by high restenosis and revascularization rates. Important progress has been made with the introduction of combination devices, including drug-eluting stents and drug-coated balloons (DCB), designed to combat restenosis by locally delivering anti-proliferative drugs. In particular, promising clinical performance has been seen with the Medtronic IN.PACT™ Admiral™ DCB, with durable, consistent and safe results. Rigorous, randomized controlled trials have directly compared this and other drug-delivering devices to their non-drug-coated counterparts with data available through two years. Additionally, trials are ongoing to assess use of drug-coated technologies in combination with traditional therapies in hope of synergistic effects. This review gathers data from currently published clinical trials with the IN.PACT Admiral DCB for the treatment of femoropopliteal peripheral artery disease and explores the possible impact on continuing clinical practice. [/INST] Exclude </s>
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Phair 2020
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Primary Patency of Long-Segment Femoropopliteal Artery Lesions in Patients with Peripheral Arterial Occlusive Disease Treated with Paclitaxel-Eluting Technology
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Background: The aim of this study is to evaluate the performance and predictors of failure of paclitaxel drug-eluting stents and paclitaxel-coated balloons in the treatment of long-segment femoropopliteal disease. We report a retrospective cohort analysis of patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in lesions >100 mm, which were not included in any of the pivotal trials. Methods: Ninety-seven patients with peripheral vascular disease (Rutherford III–VI) underwent long-segment (≥100 mm) femoropopliteal drug-eluting stent (DES) implantation or angioplasty with drug-coated balloons (DCB). Patients were followed after their initial procedure for target lesion restenosis, defined as a reduction in lumen diameter by greater than 50% as measured by duplex ultrasonography (ratio >2). Results: The median length of the affected arterial segments was 110 mm (interquartile range [IQR] 100–150, absolute range 100–260) using up to 4 overlapping stents. During the median 13-month follow-up (IQR 7–16), no early thrombotic occlusions occurred within 30 days, but 28 (29%) patients developed a target lesion restenosis after 1 year. Cumulative primary patency at 6 and 12 months was 87% and 71% overall, respectively. The cumulative patency during the same follow-up periods varied between patients treated with different paclitaxel modalities with 88% and 80% primary patency in patients treated with DES (n = 63) versus 81% and 49% in patients treated with DCB (n = 21) (adjusted hazard ratio 2.46, P = 0.03). Lesion length, concurrent tibial intervention, and recurrent target lesions were not associated with restenosis. Conclusions: Short-term outcomes in patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in long lesions, mirror results from the clinical trials. The primary patency observed in patients treated with DES was significantly higher than in patients treated with DCB.
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Exclude
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DE7 - Device not mentioned
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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: Primary Patency of Long-Segment Femoropopliteal Artery Lesions in Patients with Peripheral Arterial Occlusive Disease Treated with Paclitaxel-Eluting Technology ###Abstract: Background: The aim of this study is to evaluate the performance and predictors of failure of paclitaxel drug-eluting stents and paclitaxel-coated balloons in the treatment of long-segment femoropopliteal disease. We report a retrospective cohort analysis of patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in lesions >100 mm, which were not included in any of the pivotal trials. Methods: Ninety-seven patients with peripheral vascular disease (Rutherford III–VI) underwent long-segment (≥100 mm) femoropopliteal drug-eluting stent (DES) implantation or angioplasty with drug-coated balloons (DCB). Patients were followed after their initial procedure for target lesion restenosis, defined as a reduction in lumen diameter by greater than 50% as measured by duplex ultrasonography (ratio >2). Results: The median length of the affected arterial segments was 110 mm (interquartile range [IQR] 100–150, absolute range 100–260) using up to 4 overlapping stents. During the median 13-month follow-up (IQR 7–16), no early thrombotic occlusions occurred within 30 days, but 28 (29%) patients developed a target lesion restenosis after 1 year. Cumulative primary patency at 6 and 12 months was 87% and 71% overall, respectively. The cumulative patency during the same follow-up periods varied between patients treated with different paclitaxel modalities with 88% and 80% primary patency in patients treated with DES (n = 63) versus 81% and 49% in patients treated with DCB (n = 21) (adjusted hazard ratio 2.46, P = 0.03). Lesion length, concurrent tibial intervention, and recurrent target lesions were not associated with restenosis. Conclusions: Short-term outcomes in patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in long lesions, mirror results from the clinical trials. The primary patency observed in patients treated with DES was significantly higher than in patients treated 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: Primary Patency of Long-Segment Femoropopliteal Artery Lesions in Patients with Peripheral Arterial Occlusive Disease Treated with Paclitaxel-Eluting Technology ###Abstract: Background: The aim of this study is to evaluate the performance and predictors of failure of paclitaxel drug-eluting stents and paclitaxel-coated balloons in the treatment of long-segment femoropopliteal disease. We report a retrospective cohort analysis of patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in lesions >100 mm, which were not included in any of the pivotal trials. Methods: Ninety-seven patients with peripheral vascular disease (Rutherford III–VI) underwent long-segment (≥100 mm) femoropopliteal drug-eluting stent (DES) implantation or angioplasty with drug-coated balloons (DCB). Patients were followed after their initial procedure for target lesion restenosis, defined as a reduction in lumen diameter by greater than 50% as measured by duplex ultrasonography (ratio >2). Results: The median length of the affected arterial segments was 110 mm (interquartile range [IQR] 100–150, absolute range 100–260) using up to 4 overlapping stents. During the median 13-month follow-up (IQR 7–16), no early thrombotic occlusions occurred within 30 days, but 28 (29%) patients developed a target lesion restenosis after 1 year. Cumulative primary patency at 6 and 12 months was 87% and 71% overall, respectively. The cumulative patency during the same follow-up periods varied between patients treated with different paclitaxel modalities with 88% and 80% primary patency in patients treated with DES (n = 63) versus 81% and 49% in patients treated with DCB (n = 21) (adjusted hazard ratio 2.46, P = 0.03). Lesion length, concurrent tibial intervention, and recurrent target lesions were not associated with restenosis. Conclusions: Short-term outcomes in patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in long lesions, mirror results from the clinical trials. The primary patency observed in patients treated with DES was significantly higher than in patients treated with DCB. [/INST] Exclude </s>
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Phang 2019
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Paclitaxel-coated balloon in the treatment of recurrent dysfunctional arteriovenous access, real-world experience and longitudinal follow up
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Aim: Dysfunctional arteriovenous (AV) access remains a significant cause of morbidity and hospital admission for patients with end stage renal failure on haemodialysis. This study was performed to evaluate the impact of paclitaxel-coated Balloon (PCB) on the patency of AV access with recurrent stenoses. Methods: We retrospectively studied haemodialysis patients who presented to our centre with recurrent AV access dysfunction and compared intervention-free patency using plain balloon versus PCB. Results: A total of 147 patients were followed up longitudinally. Intervention-free patency was better following PCB compared to previous intervention using plain balloons (6.4 ± 5.8 versus 4.0 ± 3.7, P < 0.01). The 3- and 6-month patency rates after PCB were significantly better compared to standard plain angioplasty balloon: 69.4% versus 52.4%, P < 0.01 and 42.9% versus 15.6%, P < 0.01 respectively. Kaplan–Meier survival analysis of circuit patency demonstrated the superiority of PCB over plain balloon angioplasty in both arteriovenous fistula and arteriovenous graft (P < 0.01 and P = 0.01 respectively) although the patency of arteriovenous fistula remained significantly better than arteriovenous graft following interventions with PCB (P < 0.01). Age of AV access and the number of previous interventions were found to be significant predictors of patency following PCB intervention. Conclusion: Arteriovenous access intervention with PCB was shown to be superior compared to plain balloon in the treatment of both non-thrombosed and thrombosed AV accesses in our multi-ethnic population.
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DE7 - Device not mentioned
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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 in the treatment of recurrent dysfunctional arteriovenous access, real-world experience and longitudinal follow up ###Abstract: Aim: Dysfunctional arteriovenous (AV) access remains a significant cause of morbidity and hospital admission for patients with end stage renal failure on haemodialysis. This study was performed to evaluate the impact of paclitaxel-coated Balloon (PCB) on the patency of AV access with recurrent stenoses. Methods: We retrospectively studied haemodialysis patients who presented to our centre with recurrent AV access dysfunction and compared intervention-free patency using plain balloon versus PCB. Results: A total of 147 patients were followed up longitudinally. Intervention-free patency was better following PCB compared to previous intervention using plain balloons (6.4 ± 5.8 versus 4.0 ± 3.7, P < 0.01). The 3- and 6-month patency rates after PCB were significantly better compared to standard plain angioplasty balloon: 69.4% versus 52.4%, P < 0.01 and 42.9% versus 15.6%, P < 0.01 respectively. Kaplan–Meier survival analysis of circuit patency demonstrated the superiority of PCB over plain balloon angioplasty in both arteriovenous fistula and arteriovenous graft (P < 0.01 and P = 0.01 respectively) although the patency of arteriovenous fistula remained significantly better than arteriovenous graft following interventions with PCB (P < 0.01). Age of AV access and the number of previous interventions were found to be significant predictors of patency following PCB intervention. Conclusion: Arteriovenous access intervention with PCB was shown to be superior compared to plain balloon in the treatment of both non-thrombosed and thrombosed AV accesses in our multi-ethnic population. [/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 in the treatment of recurrent dysfunctional arteriovenous access, real-world experience and longitudinal follow up ###Abstract: Aim: Dysfunctional arteriovenous (AV) access remains a significant cause of morbidity and hospital admission for patients with end stage renal failure on haemodialysis. This study was performed to evaluate the impact of paclitaxel-coated Balloon (PCB) on the patency of AV access with recurrent stenoses. Methods: We retrospectively studied haemodialysis patients who presented to our centre with recurrent AV access dysfunction and compared intervention-free patency using plain balloon versus PCB. Results: A total of 147 patients were followed up longitudinally. Intervention-free patency was better following PCB compared to previous intervention using plain balloons (6.4 ± 5.8 versus 4.0 ± 3.7, P < 0.01). The 3- and 6-month patency rates after PCB were significantly better compared to standard plain angioplasty balloon: 69.4% versus 52.4%, P < 0.01 and 42.9% versus 15.6%, P < 0.01 respectively. Kaplan–Meier survival analysis of circuit patency demonstrated the superiority of PCB over plain balloon angioplasty in both arteriovenous fistula and arteriovenous graft (P < 0.01 and P = 0.01 respectively) although the patency of arteriovenous fistula remained significantly better than arteriovenous graft following interventions with PCB (P < 0.01). Age of AV access and the number of previous interventions were found to be significant predictors of patency following PCB intervention. Conclusion: Arteriovenous access intervention with PCB was shown to be superior compared to plain balloon in the treatment of both non-thrombosed and thrombosed AV accesses in our multi-ethnic population. [/INST] Exclude </s>
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Piechowiak 2020
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Endovascular treatment of tandem occlusions in vertebrobasilar stroke: Technical aspects and outcome compared with isolated basilar artery occlusion
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Background and purpose Acute basilar artery occlusion (BAO) is a devastating disease with a high rate of mortality and morbidity, and early recanalization is crucial to achieve a good prognosis. The best treatment strategy for BAO combined with a proximal stenosis (tandem occlusion) is not yet clear. Our study aimed to evaluate whether and how vertebrobasilar tandem occlusions can be treated effectively and safely compared with isolated BAO. Materials and methods Fifty-two patients with acute vertebrobasilar occlusive stroke treated with mechanical thrombectomy were identified in a prospective database from March 2010 to September 2016. We retrospectively analysed the clinical, technical, and functional outcomes of the patients. Results Of the 52 patients, 15 presented with a tandem occlusion, 14 with a single intracranial occlusion due to an underlying stenosis, and 23 with a single embolic BAO. Successful recanalization was achieved in all of the patients with tandem occlusions (modified Thrombolysis in Cranial Infarction 2b/3) and in 35 of 37 patients with a single BAO (with and without stenosis). A favourable outcome was achieved (modified Rankin Scale ≤2) in 8 of the 15 patients with a tandem occlusion compared with 4 of the 14 patients with a single BAO with underlying stenosis and 5 of the 23 patients with isolated embolic BAO (p=0.18). Conclusions We suggest that endovascular treatment of vertebrobasilar tandem occlusions is safe and feasible, with a high rate of good outcome.
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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: Endovascular treatment of tandem occlusions in vertebrobasilar stroke: Technical aspects and outcome compared with isolated basilar artery occlusion ###Abstract: Background and purpose Acute basilar artery occlusion (BAO) is a devastating disease with a high rate of mortality and morbidity, and early recanalization is crucial to achieve a good prognosis. The best treatment strategy for BAO combined with a proximal stenosis (tandem occlusion) is not yet clear. Our study aimed to evaluate whether and how vertebrobasilar tandem occlusions can be treated effectively and safely compared with isolated BAO. Materials and methods Fifty-two patients with acute vertebrobasilar occlusive stroke treated with mechanical thrombectomy were identified in a prospective database from March 2010 to September 2016. We retrospectively analysed the clinical, technical, and functional outcomes of the patients. Results Of the 52 patients, 15 presented with a tandem occlusion, 14 with a single intracranial occlusion due to an underlying stenosis, and 23 with a single embolic BAO. Successful recanalization was achieved in all of the patients with tandem occlusions (modified Thrombolysis in Cranial Infarction 2b/3) and in 35 of 37 patients with a single BAO (with and without stenosis). A favourable outcome was achieved (modified Rankin Scale ≤2) in 8 of the 15 patients with a tandem occlusion compared with 4 of the 14 patients with a single BAO with underlying stenosis and 5 of the 23 patients with isolated embolic BAO (p=0.18). Conclusions We suggest that endovascular treatment of vertebrobasilar tandem occlusions is safe and feasible, with a high rate of good outcome. [/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 tandem occlusions in vertebrobasilar stroke: Technical aspects and outcome compared with isolated basilar artery occlusion ###Abstract: Background and purpose Acute basilar artery occlusion (BAO) is a devastating disease with a high rate of mortality and morbidity, and early recanalization is crucial to achieve a good prognosis. The best treatment strategy for BAO combined with a proximal stenosis (tandem occlusion) is not yet clear. Our study aimed to evaluate whether and how vertebrobasilar tandem occlusions can be treated effectively and safely compared with isolated BAO. Materials and methods Fifty-two patients with acute vertebrobasilar occlusive stroke treated with mechanical thrombectomy were identified in a prospective database from March 2010 to September 2016. We retrospectively analysed the clinical, technical, and functional outcomes of the patients. Results Of the 52 patients, 15 presented with a tandem occlusion, 14 with a single intracranial occlusion due to an underlying stenosis, and 23 with a single embolic BAO. Successful recanalization was achieved in all of the patients with tandem occlusions (modified Thrombolysis in Cranial Infarction 2b/3) and in 35 of 37 patients with a single BAO (with and without stenosis). A favourable outcome was achieved (modified Rankin Scale ≤2) in 8 of the 15 patients with a tandem occlusion compared with 4 of the 14 patients with a single BAO with underlying stenosis and 5 of the 23 patients with isolated embolic BAO (p=0.18). Conclusions We suggest that endovascular treatment of vertebrobasilar tandem occlusions is safe and feasible, with a high rate of good outcome. [/INST] Exclude </s>
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Pohlmann 2018
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Recurrent stenosis following carotid artery stenting treated with a drug-eluting balloon: a single-center retrospective analysis
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Purpose: Early in-stent restenosis after stent-protected angioplasty of the carotid artery (SPAC) is an infrequent, but potentially harmful condition for patients with carotid artery disease. Methods: In our retrospective single-center analysis of 176 patients with carotid artery stenting between 2009 and 2015, using duplex ultrasound, we detected 9 patients with high-grade carotid artery in-stent restenosis. All restenosis patients were treated with a drug-eluting balloon (DEB) to prevent recurrent neointimal hyperplasia. One patient had bilateral carotid artery disease with bilateral in-stent restenosis, and 1 patient needed repeated DEB treatment 19 months after the first DEB intervention, so 11 DEB procedures, in total, were performed. Results: The median time-interval between primary carotid artery stenting and first DEB-treatment was 9 months. In 3 of the 11 interventions, the DEB treatment was assisted by an additional stent. One repeat DEB treatment was necessary, and three DEB treatments were followed by a secondary stent. No peri-interventional complications (TIA, stroke, or death) were observed during or after DEB intervention. Therefore, in the entire group, the 1y event-free survival (EFS) was 100%, and the 2y/3y/5y EFS was 83%. Conclusion: DEB intervention seems to be an effective and safe treatment for patients with high-grade in-stent restenosis after SPAC.
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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: Recurrent stenosis following carotid artery stenting treated with a drug-eluting balloon: a single-center retrospective analysis ###Abstract: Purpose: Early in-stent restenosis after stent-protected angioplasty of the carotid artery (SPAC) is an infrequent, but potentially harmful condition for patients with carotid artery disease. Methods: In our retrospective single-center analysis of 176 patients with carotid artery stenting between 2009 and 2015, using duplex ultrasound, we detected 9 patients with high-grade carotid artery in-stent restenosis. All restenosis patients were treated with a drug-eluting balloon (DEB) to prevent recurrent neointimal hyperplasia. One patient had bilateral carotid artery disease with bilateral in-stent restenosis, and 1 patient needed repeated DEB treatment 19 months after the first DEB intervention, so 11 DEB procedures, in total, were performed. Results: The median time-interval between primary carotid artery stenting and first DEB-treatment was 9 months. In 3 of the 11 interventions, the DEB treatment was assisted by an additional stent. One repeat DEB treatment was necessary, and three DEB treatments were followed by a secondary stent. No peri-interventional complications (TIA, stroke, or death) were observed during or after DEB intervention. Therefore, in the entire group, the 1y event-free survival (EFS) was 100%, and the 2y/3y/5y EFS was 83%. Conclusion: DEB intervention seems to be an effective and safe treatment for patients with high-grade in-stent restenosis after SPAC. [/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: Recurrent stenosis following carotid artery stenting treated with a drug-eluting balloon: a single-center retrospective analysis ###Abstract: Purpose: Early in-stent restenosis after stent-protected angioplasty of the carotid artery (SPAC) is an infrequent, but potentially harmful condition for patients with carotid artery disease. Methods: In our retrospective single-center analysis of 176 patients with carotid artery stenting between 2009 and 2015, using duplex ultrasound, we detected 9 patients with high-grade carotid artery in-stent restenosis. All restenosis patients were treated with a drug-eluting balloon (DEB) to prevent recurrent neointimal hyperplasia. One patient had bilateral carotid artery disease with bilateral in-stent restenosis, and 1 patient needed repeated DEB treatment 19 months after the first DEB intervention, so 11 DEB procedures, in total, were performed. Results: The median time-interval between primary carotid artery stenting and first DEB-treatment was 9 months. In 3 of the 11 interventions, the DEB treatment was assisted by an additional stent. One repeat DEB treatment was necessary, and three DEB treatments were followed by a secondary stent. No peri-interventional complications (TIA, stroke, or death) were observed during or after DEB intervention. Therefore, in the entire group, the 1y event-free survival (EFS) was 100%, and the 2y/3y/5y EFS was 83%. Conclusion: DEB intervention seems to be an effective and safe treatment for patients with high-grade in-stent restenosis after SPAC. [/INST] Exclude </s>
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Quintas 2017
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Iliac Artery Reconstruction with Femoral Vein After Bare Metal Stent Infection
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Introduction Primary infection of a bare metal stent is a rare condition, associated with significant morbidity and mortality. Definitive treatment includes stent removal and arterial reconstruction. Report This study details a common iliac stent infection after re-intervention for iliac stent occlusion, complicated by pseudoaneurysm formation and septic embolisation. Potential risk factors for stent infection were identified. An open surgical resection of the affected artery along with all stent material was performed, followed by reconstruction with autologous interposition superficial femoral vein. There were no complications and no recurrent infection at 6 months follow-up. Conclusion Although rare, bare metal stent infection may occur, and a high index of suspicion is required. Stent surgical removal and arterial in situ reconstruction with autologous femoral vein proved to be a definitive procedure with no mid-term morbidity.
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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: Iliac Artery Reconstruction with Femoral Vein After Bare Metal Stent Infection ###Abstract: Introduction Primary infection of a bare metal stent is a rare condition, associated with significant morbidity and mortality. Definitive treatment includes stent removal and arterial reconstruction. Report This study details a common iliac stent infection after re-intervention for iliac stent occlusion, complicated by pseudoaneurysm formation and septic embolisation. Potential risk factors for stent infection were identified. An open surgical resection of the affected artery along with all stent material was performed, followed by reconstruction with autologous interposition superficial femoral vein. There were no complications and no recurrent infection at 6 months follow-up. Conclusion Although rare, bare metal stent infection may occur, and a high index of suspicion is required. Stent surgical removal and arterial in situ reconstruction with autologous femoral vein proved to be a definitive procedure with no mid-term morbidity. [/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: Iliac Artery Reconstruction with Femoral Vein After Bare Metal Stent Infection ###Abstract: Introduction Primary infection of a bare metal stent is a rare condition, associated with significant morbidity and mortality. Definitive treatment includes stent removal and arterial reconstruction. Report This study details a common iliac stent infection after re-intervention for iliac stent occlusion, complicated by pseudoaneurysm formation and septic embolisation. Potential risk factors for stent infection were identified. An open surgical resection of the affected artery along with all stent material was performed, followed by reconstruction with autologous interposition superficial femoral vein. There were no complications and no recurrent infection at 6 months follow-up. Conclusion Although rare, bare metal stent infection may occur, and a high index of suspicion is required. Stent surgical removal and arterial in situ reconstruction with autologous femoral vein proved to be a definitive procedure with no mid-term morbidity. [/INST] Exclude </s>
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Resch 2016
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Drug Coated Balloon Is Less Effective for Treatment of DES In-Stent Restenosis Both in Native Coronary Arteries and Saphenous Vein Grafts: Results From a Bicenter Registry
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Background: The paclitaxel drug coated balloon (DCB) is an established treatment for bare metal stent (BMS) in-stent restenosis (ISR) in native coronary arteries. The evidence of DCB-application for drug eluting stent (DES) ISR both in native coronaries and saphenous vein grafts (SVG) is limited. Aim of our study was to compare the differential efficacy of DCB for treatment of BMS- and DES-ISR in native coronary vessels and SVGs. Methods and Results: N = 135 DCB-treated patients with available follow up (FU) angiography were included in this retrospective study. Patients received treatment between April 2009 and March 2013 at 2 tertiary care hospitals in Germany. DCB was applied in BMS-ISR (n = 65; 48%) and DES-ISR (n = 70; 52%). DCB-treated lesions were located in native coronary arteries (n = 110; 81%; BMS-ISR: n = 58; 53%; DES-ISR: n = 52; 47%) and SVGs (n = 25; 19%; BMS-ISR: n = 7, 28%; DES-ISR: n = 18, 72%). Median FU was 12 months. Endpoints were binary restenosis and target lesion revascularization (TLR). Binary restenosis (29% vs. 57%; P < 0.01) and TLR (18% vs. 46%; P < 0.01) were significantly more frequent in DES-ISR versus BMS-ISR. In SVGs, TLR was required in 72% (DES-ISR) versus 14% (BMS-ISR); P = 0.02. In the Kaplan–Meier-analysis freedom from both endpoints was significantly decreased in the DES-lesions both in the total population (binary restenosis P < 0.01; TLR P < 0.01) and native coronaries (binary restenosis P = 0.02; TLR P = 0.04). Conclusions: DCB treatment is less effective in DES-ISR than in BMS-ISR. The diminished efficacy of DCB treatment is even more pronounced in DES-ISR located within degenerated SVGs.
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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: Drug Coated Balloon Is Less Effective for Treatment of DES In-Stent Restenosis Both in Native Coronary Arteries and Saphenous Vein Grafts: Results From a Bicenter Registry ###Abstract: Background: The paclitaxel drug coated balloon (DCB) is an established treatment for bare metal stent (BMS) in-stent restenosis (ISR) in native coronary arteries. The evidence of DCB-application for drug eluting stent (DES) ISR both in native coronaries and saphenous vein grafts (SVG) is limited. Aim of our study was to compare the differential efficacy of DCB for treatment of BMS- and DES-ISR in native coronary vessels and SVGs. Methods and Results: N = 135 DCB-treated patients with available follow up (FU) angiography were included in this retrospective study. Patients received treatment between April 2009 and March 2013 at 2 tertiary care hospitals in Germany. DCB was applied in BMS-ISR (n = 65; 48%) and DES-ISR (n = 70; 52%). DCB-treated lesions were located in native coronary arteries (n = 110; 81%; BMS-ISR: n = 58; 53%; DES-ISR: n = 52; 47%) and SVGs (n = 25; 19%; BMS-ISR: n = 7, 28%; DES-ISR: n = 18, 72%). Median FU was 12 months. Endpoints were binary restenosis and target lesion revascularization (TLR). Binary restenosis (29% vs. 57%; P < 0.01) and TLR (18% vs. 46%; P < 0.01) were significantly more frequent in DES-ISR versus BMS-ISR. In SVGs, TLR was required in 72% (DES-ISR) versus 14% (BMS-ISR); P = 0.02. In the Kaplan–Meier-analysis freedom from both endpoints was significantly decreased in the DES-lesions both in the total population (binary restenosis P < 0.01; TLR P < 0.01) and native coronaries (binary restenosis P = 0.02; TLR P = 0.04). Conclusions: DCB treatment is less effective in DES-ISR than in BMS-ISR. The diminished efficacy of DCB treatment is even more pronounced in DES-ISR located within degenerated SVGs. [/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 Is Less Effective for Treatment of DES In-Stent Restenosis Both in Native Coronary Arteries and Saphenous Vein Grafts: Results From a Bicenter Registry ###Abstract: Background: The paclitaxel drug coated balloon (DCB) is an established treatment for bare metal stent (BMS) in-stent restenosis (ISR) in native coronary arteries. The evidence of DCB-application for drug eluting stent (DES) ISR both in native coronaries and saphenous vein grafts (SVG) is limited. Aim of our study was to compare the differential efficacy of DCB for treatment of BMS- and DES-ISR in native coronary vessels and SVGs. Methods and Results: N = 135 DCB-treated patients with available follow up (FU) angiography were included in this retrospective study. Patients received treatment between April 2009 and March 2013 at 2 tertiary care hospitals in Germany. DCB was applied in BMS-ISR (n = 65; 48%) and DES-ISR (n = 70; 52%). DCB-treated lesions were located in native coronary arteries (n = 110; 81%; BMS-ISR: n = 58; 53%; DES-ISR: n = 52; 47%) and SVGs (n = 25; 19%; BMS-ISR: n = 7, 28%; DES-ISR: n = 18, 72%). Median FU was 12 months. Endpoints were binary restenosis and target lesion revascularization (TLR). Binary restenosis (29% vs. 57%; P < 0.01) and TLR (18% vs. 46%; P < 0.01) were significantly more frequent in DES-ISR versus BMS-ISR. In SVGs, TLR was required in 72% (DES-ISR) versus 14% (BMS-ISR); P = 0.02. In the Kaplan–Meier-analysis freedom from both endpoints was significantly decreased in the DES-lesions both in the total population (binary restenosis P < 0.01; TLR P < 0.01) and native coronaries (binary restenosis P = 0.02; TLR P = 0.04). Conclusions: DCB treatment is less effective in DES-ISR than in BMS-ISR. The diminished efficacy of DCB treatment is even more pronounced in DES-ISR located within degenerated SVGs. [/INST] Exclude </s>
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Rissanen 2019
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Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial
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Background: The optimal technique of percutaneous coronary intervention in patients at high bleeding risk is not known. The hypothesis of the DEBUT trial was that percutaneous coronary intervention with drug-coated balloons is non-inferior to percutaneous coronary intervention with bare-metal stents for this population. Methods: The DEBUT trial is a randomised, single-blind non-inferiority trial done at five sites in Finland. Patients were eligible if they had an ischaemic de-novo lesion in a coronary artery or bypass graft that could be treated with drug-coated balloons, at least one risk factor for bleeding, and a reference vessel diameter of 2·5–4·0 mm. Those with myocardial infarction with ST-elevation, bifurcation lesions needing a two-stent technique, in-stent restenosis, and flow-limiting dissection or substantial recoil (>30%) of the target lesion after predilation were excluded. After successful predilation of the target lesion, patients were randomly assigned (1:1), by use of a computer-generated random sequence, to percutaneous coronary intervention with a balloon coated with paclitaxel and iopromide or a bare-metal stent. The primary outcome was major adverse cardiac events at 9 months. Non-inferiority was shown if the absolute risk difference was no more than 3%. All prespecified analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01781546. Findings: Between May 22, 2013, and Jan 16, 2017, 220 patients were recruited for the study and 208 patients were assigned to percutaneous coronary intervention with drug-coated balloon (n=102) or bare metal stent (n=106). At 9 months, major adverse cardiac events had occurred in one patient (1%) in the drug-coated balloon group and in 15 patients (14%) in the bare-metal stent group (absolute risk difference −13·2 percentage points [95% CI −6·2 to −21·1], risk ratio 0·07 [95% CI 0·01 to 0·52]; p<0·00001 for non-inferiority and p=0·00034 for superiority). Two definitive stent thrombosis events occurred in the bare metal stent group but no acute vessel closures in the drug-coated balloon group. Interpretations: Percutaneous coronary intervention with drug-coated balloon was superior to bare-metal stents in patients at bleeding risk. The drug-coated balloon-only coronary intervention is a novel strategy to treat this difficult patient population. Comparison of this approach to the new generation drug-eluting stents is warranted in the future. Funding: B Braun Medical AG, AstraZeneca, and Competitive State Research Funding of the Kuopio University Hospital Catchment Area.
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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: Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial ###Abstract: Background: The optimal technique of percutaneous coronary intervention in patients at high bleeding risk is not known. The hypothesis of the DEBUT trial was that percutaneous coronary intervention with drug-coated balloons is non-inferior to percutaneous coronary intervention with bare-metal stents for this population. Methods: The DEBUT trial is a randomised, single-blind non-inferiority trial done at five sites in Finland. Patients were eligible if they had an ischaemic de-novo lesion in a coronary artery or bypass graft that could be treated with drug-coated balloons, at least one risk factor for bleeding, and a reference vessel diameter of 2·5–4·0 mm. Those with myocardial infarction with ST-elevation, bifurcation lesions needing a two-stent technique, in-stent restenosis, and flow-limiting dissection or substantial recoil (>30%) of the target lesion after predilation were excluded. After successful predilation of the target lesion, patients were randomly assigned (1:1), by use of a computer-generated random sequence, to percutaneous coronary intervention with a balloon coated with paclitaxel and iopromide or a bare-metal stent. The primary outcome was major adverse cardiac events at 9 months. Non-inferiority was shown if the absolute risk difference was no more than 3%. All prespecified analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01781546. Findings: Between May 22, 2013, and Jan 16, 2017, 220 patients were recruited for the study and 208 patients were assigned to percutaneous coronary intervention with drug-coated balloon (n=102) or bare metal stent (n=106). At 9 months, major adverse cardiac events had occurred in one patient (1%) in the drug-coated balloon group and in 15 patients (14%) in the bare-metal stent group (absolute risk difference −13·2 percentage points [95% CI −6·2 to −21·1], risk ratio 0·07 [95% CI 0·01 to 0·52]; p<0·00001 for non-inferiority and p=0·00034 for superiority). Two definitive stent thrombosis events occurred in the bare metal stent group but no acute vessel closures in the drug-coated balloon group. Interpretations: Percutaneous coronary intervention with drug-coated balloon was superior to bare-metal stents in patients at bleeding risk. The drug-coated balloon-only coronary intervention is a novel strategy to treat this difficult patient population. Comparison of this approach to the new generation drug-eluting stents is warranted in the future. Funding: B Braun Medical AG, AstraZeneca, and Competitive State Research Funding of the Kuopio University Hospital Catchment Area. [/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 for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial ###Abstract: Background: The optimal technique of percutaneous coronary intervention in patients at high bleeding risk is not known. The hypothesis of the DEBUT trial was that percutaneous coronary intervention with drug-coated balloons is non-inferior to percutaneous coronary intervention with bare-metal stents for this population. Methods: The DEBUT trial is a randomised, single-blind non-inferiority trial done at five sites in Finland. Patients were eligible if they had an ischaemic de-novo lesion in a coronary artery or bypass graft that could be treated with drug-coated balloons, at least one risk factor for bleeding, and a reference vessel diameter of 2·5–4·0 mm. Those with myocardial infarction with ST-elevation, bifurcation lesions needing a two-stent technique, in-stent restenosis, and flow-limiting dissection or substantial recoil (>30%) of the target lesion after predilation were excluded. After successful predilation of the target lesion, patients were randomly assigned (1:1), by use of a computer-generated random sequence, to percutaneous coronary intervention with a balloon coated with paclitaxel and iopromide or a bare-metal stent. The primary outcome was major adverse cardiac events at 9 months. Non-inferiority was shown if the absolute risk difference was no more than 3%. All prespecified analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01781546. Findings: Between May 22, 2013, and Jan 16, 2017, 220 patients were recruited for the study and 208 patients were assigned to percutaneous coronary intervention with drug-coated balloon (n=102) or bare metal stent (n=106). At 9 months, major adverse cardiac events had occurred in one patient (1%) in the drug-coated balloon group and in 15 patients (14%) in the bare-metal stent group (absolute risk difference −13·2 percentage points [95% CI −6·2 to −21·1], risk ratio 0·07 [95% CI 0·01 to 0·52]; p<0·00001 for non-inferiority and p=0·00034 for superiority). Two definitive stent thrombosis events occurred in the bare metal stent group but no acute vessel closures in the drug-coated balloon group. Interpretations: Percutaneous coronary intervention with drug-coated balloon was superior to bare-metal stents in patients at bleeding risk. The drug-coated balloon-only coronary intervention is a novel strategy to treat this difficult patient population. Comparison of this approach to the new generation drug-eluting stents is warranted in the future. Funding: B Braun Medical AG, AstraZeneca, and Competitive State Research Funding of the Kuopio University Hospital Catchment Area. [/INST] Exclude </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
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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.
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Exclude
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DE7 - Device not mentioned
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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 ###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. [/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: Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: Results of a randomized clinical trial ###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. [/INST] Exclude </s>
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Sakata 2018
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Paclitaxel-coated balloon dilation for central airway obstruction
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Introduction: Central airway obstruction (CAO) often requires repeated interventional procedures which offer variable efficacy, a time-limited effect, and have inherent limitations. Paclitaxel has been used to prevent restenosis in blood vessels. The literature describing the use of paclitaxel to prevent recurrent airway stenosis is limited. We sought to describe our experience using a paclitaxel-coated balloon (PCB) for CAO. Material and methods: We performed a retrospective review of all patients who underwent PCB airway dilation. We collected: basic demographics, details of the CAO, details of the bronchoscopes used, PCB size, PCB dilation pressure, duration of PCB inflation, concurrent non-PCB interventions, estimated pre- and post-PCB CAO luminal diameter, follow up bronchoscopy date and luminal diameter, and spirometry results. Results: PCB dilation was performed in 10 cases on 5 patients. Eight PCB dilations were performed for CAO related to distal airway stent stenosis. Concurrent non-PCB interventions were performed with 6 PCB dilations. Nine cases documented improvements and 1 was unchanged immediately post-PCB dilation. Median luminal diameter pre-PCB dilation was 2 mm. Immediately post-PCB dilation, the median change in luminal diameter was 2 mm. Follow up bronchoscopy information was available for 9 cases. For these 9 cases, luminal diameter was unchanged in 5 and worse in 4 when compared to immediate post-PCB dilation. Conclusion: PCB dilation in benign CAO produced a modest effect in this cohort of challenging airways. Larger prospective studies are needed to assess how a PCB would perform when compared to a non-drug coated balloon.
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Exclude
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DE2 - Wrong Topic
|
<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 dilation for central airway obstruction ###Abstract: Introduction: Central airway obstruction (CAO) often requires repeated interventional procedures which offer variable efficacy, a time-limited effect, and have inherent limitations. Paclitaxel has been used to prevent restenosis in blood vessels. The literature describing the use of paclitaxel to prevent recurrent airway stenosis is limited. We sought to describe our experience using a paclitaxel-coated balloon (PCB) for CAO. Material and methods: We performed a retrospective review of all patients who underwent PCB airway dilation. We collected: basic demographics, details of the CAO, details of the bronchoscopes used, PCB size, PCB dilation pressure, duration of PCB inflation, concurrent non-PCB interventions, estimated pre- and post-PCB CAO luminal diameter, follow up bronchoscopy date and luminal diameter, and spirometry results. Results: PCB dilation was performed in 10 cases on 5 patients. Eight PCB dilations were performed for CAO related to distal airway stent stenosis. Concurrent non-PCB interventions were performed with 6 PCB dilations. Nine cases documented improvements and 1 was unchanged immediately post-PCB dilation. Median luminal diameter pre-PCB dilation was 2 mm. Immediately post-PCB dilation, the median change in luminal diameter was 2 mm. Follow up bronchoscopy information was available for 9 cases. For these 9 cases, luminal diameter was unchanged in 5 and worse in 4 when compared to immediate post-PCB dilation. Conclusion: PCB dilation in benign CAO produced a modest effect in this cohort of challenging airways. Larger prospective studies are needed to assess how a PCB would perform when compared to a non-drug coated balloon. [/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: Paclitaxel-coated balloon dilation for central airway obstruction ###Abstract: Introduction: Central airway obstruction (CAO) often requires repeated interventional procedures which offer variable efficacy, a time-limited effect, and have inherent limitations. Paclitaxel has been used to prevent restenosis in blood vessels. The literature describing the use of paclitaxel to prevent recurrent airway stenosis is limited. We sought to describe our experience using a paclitaxel-coated balloon (PCB) for CAO. Material and methods: We performed a retrospective review of all patients who underwent PCB airway dilation. We collected: basic demographics, details of the CAO, details of the bronchoscopes used, PCB size, PCB dilation pressure, duration of PCB inflation, concurrent non-PCB interventions, estimated pre- and post-PCB CAO luminal diameter, follow up bronchoscopy date and luminal diameter, and spirometry results. Results: PCB dilation was performed in 10 cases on 5 patients. Eight PCB dilations were performed for CAO related to distal airway stent stenosis. Concurrent non-PCB interventions were performed with 6 PCB dilations. Nine cases documented improvements and 1 was unchanged immediately post-PCB dilation. Median luminal diameter pre-PCB dilation was 2 mm. Immediately post-PCB dilation, the median change in luminal diameter was 2 mm. Follow up bronchoscopy information was available for 9 cases. For these 9 cases, luminal diameter was unchanged in 5 and worse in 4 when compared to immediate post-PCB dilation. Conclusion: PCB dilation in benign CAO produced a modest effect in this cohort of challenging airways. Larger prospective studies are needed to assess how a PCB would perform when compared to a non-drug coated balloon. [/INST] Exclude </s>
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San Norberto 2019
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Endovascular Treatment of Popliteal Artery Occlusion Caused by a Ruptured Supera Interwoven Nitinol Stent
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The Supera peripheral stent system has a woven wire design that may confer a potential advantage and has higher resistive radial strength of traditional stents, which gives it the ability to avoid kinking. Because a stent is a permanent implant in the target vessels and they would be subjected to a wide variety of torsion, compression, and stress, a rupture is not surprising. Only three cases of ruptured Supera stents have been published in literature. We present a case of P2 popliteal segment thrombosis secondary to Supera stent fracture. A 51-year-old male patient presented with lifestyle-limiting intermittent claudication after 6 months of popliteal recanalization and Supera stent implantation. The computed tomography angiography demonstrated a popliteal artery occlusion secondary to stent fracture. The lesion was satisfactorily treated by endovascular recanalization and with a new Supera stent deployment. The duplex examination after 3 and 6 months demonstrated stent's permeability, and the plain anteroposterior and lateral radiographs did not reveal new stent fractures. Our data suggested that Supera stents are not free of fractures during follow-up and their treatment depends on the type of fracture, with the possibility for endovascular treatment in type III fractures.
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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: Endovascular Treatment of Popliteal Artery Occlusion Caused by a Ruptured Supera Interwoven Nitinol Stent ###Abstract: The Supera peripheral stent system has a woven wire design that may confer a potential advantage and has higher resistive radial strength of traditional stents, which gives it the ability to avoid kinking. Because a stent is a permanent implant in the target vessels and they would be subjected to a wide variety of torsion, compression, and stress, a rupture is not surprising. Only three cases of ruptured Supera stents have been published in literature. We present a case of P2 popliteal segment thrombosis secondary to Supera stent fracture. A 51-year-old male patient presented with lifestyle-limiting intermittent claudication after 6 months of popliteal recanalization and Supera stent implantation. The computed tomography angiography demonstrated a popliteal artery occlusion secondary to stent fracture. The lesion was satisfactorily treated by endovascular recanalization and with a new Supera stent deployment. The duplex examination after 3 and 6 months demonstrated stent's permeability, and the plain anteroposterior and lateral radiographs did not reveal new stent fractures. Our data suggested that Supera stents are not free of fractures during follow-up and their treatment depends on the type of fracture, with the possibility for endovascular treatment in type III fractures. [/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: Endovascular Treatment of Popliteal Artery Occlusion Caused by a Ruptured Supera Interwoven Nitinol Stent ###Abstract: The Supera peripheral stent system has a woven wire design that may confer a potential advantage and has higher resistive radial strength of traditional stents, which gives it the ability to avoid kinking. Because a stent is a permanent implant in the target vessels and they would be subjected to a wide variety of torsion, compression, and stress, a rupture is not surprising. Only three cases of ruptured Supera stents have been published in literature. We present a case of P2 popliteal segment thrombosis secondary to Supera stent fracture. A 51-year-old male patient presented with lifestyle-limiting intermittent claudication after 6 months of popliteal recanalization and Supera stent implantation. The computed tomography angiography demonstrated a popliteal artery occlusion secondary to stent fracture. The lesion was satisfactorily treated by endovascular recanalization and with a new Supera stent deployment. The duplex examination after 3 and 6 months demonstrated stent's permeability, and the plain anteroposterior and lateral radiographs did not reveal new stent fractures. Our data suggested that Supera stents are not free of fractures during follow-up and their treatment depends on the type of fracture, with the possibility for endovascular treatment in type III fractures. [/INST] Exclude </s>
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Saratzis 2020
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Paclitaxel and Mortality Following Peripheral Angioplasty: An Adjusted and Case Matched Multicentre Analysis
|
Objective: Paclitaxel based drug coated balloons (DCBs) and drug eluting stents (DESs) may be associated with increased mortality in patients with peripheral arterial occlusive disease (PAOD), based on a recent meta-analysis. This study, however, had a number of limitations, which have been discussed at great length among the vascular community. The aim of this research was to assess the association between paclitaxel based endovascular treatment (PTX) in the femoropopliteal (F–P) segment and mortality, adjusting for relevant risk factors and including patients with chronic limb threatening ischaemia (CLTI). Methods: This was a retrospective cohort study of a prospectively maintained multicentre (three sites) database of patients with claudication or CLTI. Patients having F–P angioplasty between 1 January 2014 and 30 May 2019 with or without PTX were included. Survival was compared in Cox regression analyses adjusted for parameters of the Charlson comorbidity index. A separate nested case matched (based on each individual's Charlson index) analysis was performed to compare mortality rates between those who received PTX and those who did not. Results: A total of 2 071 patients were analysed: 966 patients (46.6%) were treated with PTX (952 [46%] had CLTI and 1 119 [54%] severe claudication [Rutherford stage 3]). Over a 24 month median follow up, 456 (22.1%) patients died. Using multivariable Cox regression, PTX was not associated with mortality (HR 0.94, p =.46), even when assessed separately for those with intermittent claudication (HR 1.30, p =.15) or CLTI (HR 0.81, p =.060). In the case matched analysis (885 matched pairs of patients), PTX was not associated with mortality (HR 0.89, p =.17). Paclitaxel dose and use of a DCB or DES were not associated with mortality in any subanalysis. Conclusion: When relevant risk factors were taken into account, there were no associations between PTX and mid term mortality in patients with PAOD.
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Exclude
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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 and Mortality Following Peripheral Angioplasty: An Adjusted and Case Matched Multicentre Analysis ###Abstract: Objective: Paclitaxel based drug coated balloons (DCBs) and drug eluting stents (DESs) may be associated with increased mortality in patients with peripheral arterial occlusive disease (PAOD), based on a recent meta-analysis. This study, however, had a number of limitations, which have been discussed at great length among the vascular community. The aim of this research was to assess the association between paclitaxel based endovascular treatment (PTX) in the femoropopliteal (F–P) segment and mortality, adjusting for relevant risk factors and including patients with chronic limb threatening ischaemia (CLTI). Methods: This was a retrospective cohort study of a prospectively maintained multicentre (three sites) database of patients with claudication or CLTI. Patients having F–P angioplasty between 1 January 2014 and 30 May 2019 with or without PTX were included. Survival was compared in Cox regression analyses adjusted for parameters of the Charlson comorbidity index. A separate nested case matched (based on each individual's Charlson index) analysis was performed to compare mortality rates between those who received PTX and those who did not. Results: A total of 2 071 patients were analysed: 966 patients (46.6%) were treated with PTX (952 [46%] had CLTI and 1 119 [54%] severe claudication [Rutherford stage 3]). Over a 24 month median follow up, 456 (22.1%) patients died. Using multivariable Cox regression, PTX was not associated with mortality (HR 0.94, p =.46), even when assessed separately for those with intermittent claudication (HR 1.30, p =.15) or CLTI (HR 0.81, p =.060). In the case matched analysis (885 matched pairs of patients), PTX was not associated with mortality (HR 0.89, p =.17). Paclitaxel dose and use of a DCB or DES were not associated with mortality in any subanalysis. Conclusion: When relevant risk factors were taken into account, there were no associations between PTX and mid term mortality in patients with PAOD. [/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: Paclitaxel and Mortality Following Peripheral Angioplasty: An Adjusted and Case Matched Multicentre Analysis ###Abstract: Objective: Paclitaxel based drug coated balloons (DCBs) and drug eluting stents (DESs) may be associated with increased mortality in patients with peripheral arterial occlusive disease (PAOD), based on a recent meta-analysis. This study, however, had a number of limitations, which have been discussed at great length among the vascular community. The aim of this research was to assess the association between paclitaxel based endovascular treatment (PTX) in the femoropopliteal (F–P) segment and mortality, adjusting for relevant risk factors and including patients with chronic limb threatening ischaemia (CLTI). Methods: This was a retrospective cohort study of a prospectively maintained multicentre (three sites) database of patients with claudication or CLTI. Patients having F–P angioplasty between 1 January 2014 and 30 May 2019 with or without PTX were included. Survival was compared in Cox regression analyses adjusted for parameters of the Charlson comorbidity index. A separate nested case matched (based on each individual's Charlson index) analysis was performed to compare mortality rates between those who received PTX and those who did not. Results: A total of 2 071 patients were analysed: 966 patients (46.6%) were treated with PTX (952 [46%] had CLTI and 1 119 [54%] severe claudication [Rutherford stage 3]). Over a 24 month median follow up, 456 (22.1%) patients died. Using multivariable Cox regression, PTX was not associated with mortality (HR 0.94, p =.46), even when assessed separately for those with intermittent claudication (HR 1.30, p =.15) or CLTI (HR 0.81, p =.060). In the case matched analysis (885 matched pairs of patients), PTX was not associated with mortality (HR 0.89, p =.17). Paclitaxel dose and use of a DCB or DES were not associated with mortality in any subanalysis. Conclusion: When relevant risk factors were taken into account, there were no associations between PTX and mid term mortality in patients with PAOD. [/INST] Exclude </s>
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Sauguet 2019
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Directional atherectomy with antirestenotic therapy for the treatment of no-stenting zones
|
Endovascular treatment for peripheral artery occlusive disease carries unresolved problem of restenosis. Treatment modalities in areas of high mechanical stress like popliteal artery and common femoral artery remains challenging. New-generation devices improved the results of stent therapy in this anatomical territory, but could impact on future surgical options if they are needed. Vessel preparation prior to drug (paclitaxel)- coated balloons (DCB) angioplasty leads to better paclitaxel penetration into the arterial wall and improved drug uptake. The "leave nothing behind" strategies, DCB angioplasty and combined directional atherectomy (DA) and antirestenotic therapy (DAART), can theoretically overcome the problems caused by the mobility of the knee joint. However, calcified and longer lesions remain a challenging subset that is less responsive to DCBs, resulting in higher provisional stent rates. For the treatment of long and calcified femoropopliteal lesions, vessel preparation with DA before DCB angioplasty seems to be safe in mid-term follow-up and might have benefits in more challenging lesion subsets that are at higher risk for acute and chronic technical treatment failure of percutaneous transluminal angioplasty, including DCB angioplasty, such as severely calcified lesions. Treatment with DA+DCB resulted in both increased technical success and fewer flow-limiting dissections compared with treatment with DCB alone. In concept of "leave nothing behind" therapies for isolated popliteal artery lesions, DAART was associated with a higher primary patency rate than DCB angioplasty alone.
|
Exclude
|
DE10 - 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: Directional atherectomy with antirestenotic therapy for the treatment of no-stenting zones ###Abstract: Endovascular treatment for peripheral artery occlusive disease carries unresolved problem of restenosis. Treatment modalities in areas of high mechanical stress like popliteal artery and common femoral artery remains challenging. New-generation devices improved the results of stent therapy in this anatomical territory, but could impact on future surgical options if they are needed. Vessel preparation prior to drug (paclitaxel)- coated balloons (DCB) angioplasty leads to better paclitaxel penetration into the arterial wall and improved drug uptake. The "leave nothing behind" strategies, DCB angioplasty and combined directional atherectomy (DA) and antirestenotic therapy (DAART), can theoretically overcome the problems caused by the mobility of the knee joint. However, calcified and longer lesions remain a challenging subset that is less responsive to DCBs, resulting in higher provisional stent rates. For the treatment of long and calcified femoropopliteal lesions, vessel preparation with DA before DCB angioplasty seems to be safe in mid-term follow-up and might have benefits in more challenging lesion subsets that are at higher risk for acute and chronic technical treatment failure of percutaneous transluminal angioplasty, including DCB angioplasty, such as severely calcified lesions. Treatment with DA+DCB resulted in both increased technical success and fewer flow-limiting dissections compared with treatment with DCB alone. In concept of "leave nothing behind" therapies for isolated popliteal artery lesions, DAART was associated with a higher primary patency rate than DCB angioplasty alone. [/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: Directional atherectomy with antirestenotic therapy for the treatment of no-stenting zones ###Abstract: Endovascular treatment for peripheral artery occlusive disease carries unresolved problem of restenosis. Treatment modalities in areas of high mechanical stress like popliteal artery and common femoral artery remains challenging. New-generation devices improved the results of stent therapy in this anatomical territory, but could impact on future surgical options if they are needed. Vessel preparation prior to drug (paclitaxel)- coated balloons (DCB) angioplasty leads to better paclitaxel penetration into the arterial wall and improved drug uptake. The "leave nothing behind" strategies, DCB angioplasty and combined directional atherectomy (DA) and antirestenotic therapy (DAART), can theoretically overcome the problems caused by the mobility of the knee joint. However, calcified and longer lesions remain a challenging subset that is less responsive to DCBs, resulting in higher provisional stent rates. For the treatment of long and calcified femoropopliteal lesions, vessel preparation with DA before DCB angioplasty seems to be safe in mid-term follow-up and might have benefits in more challenging lesion subsets that are at higher risk for acute and chronic technical treatment failure of percutaneous transluminal angioplasty, including DCB angioplasty, such as severely calcified lesions. Treatment with DA+DCB resulted in both increased technical success and fewer flow-limiting dissections compared with treatment with DCB alone. In concept of "leave nothing behind" therapies for isolated popliteal artery lesions, DAART was associated with a higher primary patency rate than DCB angioplasty alone. [/INST] Exclude </s>
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