bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluation of traditional and non-traditional risk factors as predictive values for a positive acetylcholine provocation test in patients with ischemia and no obstructive coronary artery disease
Authors: Beijderwellen E , Feenstra R.G.T , Beijk M.A.M , Wittekoek M.E , Stegehuis V.E , Piek J.J 
Published: November 2020

Abstract

Background
Coronary vasomotor function disorders, such as microvascular angina (MVA) and vasospastic angina (VSA) can be diagnosed in three quarters of all patients with signs and symptoms of ischemia and no obstructive coronary artery disease (INOCA). Intracoronary acetylcholine provocation testing (Ach-test) is considered the gold standard for the assessment of VSA and MVA. Our aim is to identify the correlation between a positive Ach-test identifying an abnormal coronary vasomotor response and predictive traditional and non-traditional risk factors in patients with INOCA.

Methods
In this single centre retrospective cohort study, data from all patients who were referred for an Ach-test between 2002 and 2019 was collected. All patients underwent an invasive test with assessment of the vasomotor responses by intracoronary acetylcholine and assessment of coronary microvascular dysfunction (CMD) by measuring the coronary flow reserve (CFR). VSA and MVA were diagnosed on the basis of the criteria as proposed by the Coronary Vasomotor Disorders International Study Group (COVADIS). The predictive risk factors were analyzed by means of logistic regression.

Results
A total of 134 patients were included, median age was 57 years and 85.1% were female. The Ach-test revealed VSA in 95 patients (70.9%), MVA in 13 patients (9.7%) and a negative Ach-test in 26 patients (19.4%). A multivariable logistic regression model showed smoking as an independent variable for a positive Ach-test (OR of 3.0 with 95% CI 1.1–8.2; p=0.031) and as an independent predictor for VSA (OR of 2.9 95% CI 1.1–7.9 p=0.039). In addition we showed that migraine (OR of 6.7 95% CI 1.4–32.9 p=0.019) is an independent predictor for MVA and MVA has a strong association with female patients who have a history of recurrent miscarriages (p=0.015).

Conclusion
MVA and VSA are associated with different risk factors which support a different underlying pathophysiology. Smoking is an independent predictor for a positive Ach-test and an independent predictor for VSA. In addition, we showed that migraine is an independent predictor for MVA and MVA has a strong association with female patients who have a history of miscarriages. MVA and VSA require a different treatment strategy and because there are no clear predictive values for a positive Ach-test, it is important to support identification with an Ach-test.

Funding Acknowledgement
Type of funding source: None
PCI complexity and cardiovascular risk in relation to high bleeding risk among patients receiving drug-eluting Stents: insight from China Fuwai PCI registry
Authors: Wang H.Y , Gao R.L , Xu B , Kirtane A , Dou K 
Published: November 2020

Abstract

Background
The relation between complex percutaneous coronary intervention (PCI), high bleeding risk (HBR), and adverse events after coronary artery implantation of drug-eluting stents has been incompletely characterized. This study sought to investigate the ischemic and bleeding events after complex PCI including a stratification according to HBR estimated by PARIS bleeding risk score.

Methods
Between January 2013 and December 2013, 10,167 consecutive patients undergoing PCI were prospectively enrolled in Fuwai PCI Registry. Complex PCI was defined when having at least one of the following characteristics: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length &gt;60 mm, treatment of chronic total occlusion, unprotected left main PCI, in-stent restenosis target lesion, and severely calcified lesion requiring a rotablator system. The primary ischemic endpoint was major adverse cardiovascular events (MACE) [composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis], and primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding.

Results
The median duration of follow-up was 30 months. In adjusted Cox regression analysis, patients having complex PCI procedures experienced higher risks of MACE (hazard ratio [HR]: 1.63, 95% confidence interval [CI]: 1.38–1.92; P&lt;0.001), compared with non-complex PCI. In contrast, the risk of clinically relevant bleeding was statistically similar between the 2 groups (HR: 0.86 [0.66–1.11]; P=0.238). There was no statistical interaction between HBR (PARIS bleeding score ≥8 or &lt;8) and complex PCI in regard to MACE (adjusted Pinteraction=0.388) and clinically relevant bleeding (adjusted Pinteraction=0.279).

Conclusions
Patients who had undergone complex PCI resulted in substantially more ischemic events, without an increase in clinically relevant bleeding risk; and these associations did not seem to be modified by HBR status. More intensified antiplatelet therapy may be beneficial for patients with complex percutaneous coronary revascularization procedures.

Funding Acknowledgement
Type of funding source: Foundation. Main funding source(s): Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences;National Natural Science Foundation of China
Suppression of gastric acid secretion decreased cardiovascular events independent of severe bleeding events in patients after percutaneous coronary intervention – sub-analysis from multicenter registry
Authors: Kamishima K , Jujo K , Tanaka H , Hata T , Ota Y , Oka T , Koganei H , Kobayashi H , Mori F , Sakamoto T , Yamaguchi J , Hagiwara N 
Published: November 2020

Abstract

Background
Suppression of gastric acid secretion by proton-pump inhibitor (PPI) or potassium-competitive acid blocker (P-CAB) has recently been developed as a standard strategy for preventing gastrointestinal bleeding for patients receiving antiplatelet therapy after percutaneous coronary intervention (PCI). However, there has been limited evidences on the association between PPI/P-CAB administration and adverse cardiovascular events in patients undergoing PCI.

Purpose
We aimed to evaluate the prognostic impact of the prescription of PPI/P-CAB on clinical outcomes in patients after PCI.

Methods
This study is a subanalysis from the TWINCRE registry that is a multicentral prospective cohort including patients who underwent PCI at 12 hospitals in Japan between 2017 and 2019. Among registered patients, we ultimately evaluated 1,428 patients who were followed-up. They were divided into two groups by the prescriptions of PPI or P-CAB at discharge for the index PCI; the PPI/P-CAB group (n=1,023), and the Non-PPI/P-CAB group (n=407). The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE) including death, acute coronary syndrome, stent thrombosis, hospitalization due to heart failure and ischemic stroke. Secondary endpoints was major bleeding events defined BARC3, 4 and 5.

Results
The average age of the study population was 70.3 years and 80.3% were male. Baseline clinical profiles were comparable between the groups, except that the PPI/P-CAB group included significantly higher rate of patients who had history of prior PCI (28.4% vs 18.7%, P=0.02). Additionally, there was no significant difference in the duration of dual antiplatelet therapy between the PPI/P-CAB group and Non-PPI/P-CAB group (average duration; 287±8 vs. 285±8 days, P=0.66). Overall, MACCE was developed in 132 patients (9.3%), and bleeding event was observed in 24 patients (1.7%) during 574 days of median follow-up period. Kaplan-Meier analysis showed that patients in the PPI/P-CAB group had a significantly lower rate of MACCE than those in the Non-PPI/P-CAB group (Log-rank test, p=0.0003, Figure 1A). Multivariate Cox regression analysis revealed that the prescription of PPI/P-CAB still was independently associated with the primary endpoint (hazard ratio 0.532, 95% confidence interval 0.369–0.766, p=0.0007), even after the adjustment by diverse covariates. Whereas, there was no significant difference in the bleeding event (p=0.64, Figure 1B).

Conclusion
PPI or P-CAB therapy was associated with better clinical outcomes after PCI, independent of the incidences of severe bleeding events.
Figure 1

Funding Acknowledgement
Type of funding source: None
Comparative Effectiveness of CABG versus PCI in Patients with Ischemic Heart Disease: insights from SWEDEHEART Registry
Authors: Redfors B , Volz S , Angeras O , Ioanes D , Odenstedt J , Haraldsson I , Dworeck C , Myredal A , Hirlekar G , Ramunddal T , Petursson P , Bollano E , Dellgren G , Jeppsson A , Omerovic E 
Published: November 2020

Abstract

Background
Several studies have compared CABG to PCI as revascularization treatment in patients with ischemic heart disease (IHD). However, it remains unclear which revascularization strategy carries survival benefits in the long-term.

Methods
We used data from the SWEDEHEART (Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry for all hospital admissions at 13 cardiac care centers within Västra Götaland County in Sweden (∼20% of all SWEDEHEART data). The database contains &gt;1000 clinical variables documenting the entire process of acute coronary hospital care. All patients hospitalized for stable angina or NSTE-ACS during the period 2000–2018 were included in the analysis. We used a propensity score-adjusted Cox proportional-hazards regression with hospitals as random-effect variables. We adjusted for patients' demographics, socio-economic status, traditional risk factors, comorbidities, the severity of coronary artery disease, left ventricular function, calendar year and medication at discharge. For sensitivity analysis, we used the instrumental variable estimator for the Cox proportional-hazards model (with treating hospital as a treatment-preference instrument) to simultaneously deal with the problems of unmeasured confounding and censoring of the outcome. The primary outcome was all-cause mortality.

Results
In total, 11,896 patients were included in the study. Of these, 3,129 (26.3%) were women. 20.4% had diabetes and 10.4% had a previous myocardial infarction. The mean age was 66.7±10.7, and 42.9% were &gt;70 years old. 61.5% had three-vessel and/or left main disease. Median follow-up time was 5.7 years (range 1 day-18.2 years). Revascularization therapy after coronary angiography was PCI in 9449 (79.4%) and CABG in 2,447 (20.6%) patients. CABG patients were more likely to have diabetes, left main/multivessel disease and heart failure. The number of revascularized patients with PCI increased by 6.4% per calendar year (P&lt;0.001). There were 2,481 (20.9%) deaths. CABG was associated with a lower risk of death compared to PCI (HR 0.81; 95% CI 0.69–0.95; P=0.011. We found no evidence for treatment heterogeneity between the revascularization strategy and age, gender, diabetes, heart failure and indication for revascularization (all P-interaction &gt;0.05). Results from the sensitivity analysis support the conclusions from the primary model.

Conclusions
In hospitalized patients due to IHD, revascularization with CABG was associated with superior long-term survival compared to PCI.

Funding Acknowledgement
Type of funding source: Foundation. Main funding source(s): Heart and Lung Foundation, ALF Västra Götaland, Swedish Scientific Council
Safety and efficacy of the treatment of in-stent restenosis and de novo complex lesions with the novel paclitaxel-coated scoring balloon (Angiosculpt X)
Authors: Agip Fustamante D.P , Ortiz Cruces S , Camacho Freire S , Gutierrez Barrios A , Gomez Menchero A , Canadas Pruano D , Roa Garrido J , Calle Perez G , Cardenal Piris R , Diaz Fernandez J 
Published: November 2020

Abstract

Background
The AngioSculpt X (Spectranetics) is a novel paclitaxel-coated scoring balloon with encouraging preliminary data for the treatment of in-stent restenosis or de novo complex lesions.

Purpose
To assess the safety and efficacy of real-world patients with in-stent restenosis (ISR) or de novo complex lesions (vessels &lt;2.5 mm, calcified lesions, bifurcation lesions...) treated with the novel paclitaxel-coated scoring balloon.

Methods
A “real-world”, prospective registry from two centers was performed including consecutive patients presenting with ISR or de novo complex lesions and treated with AngioSculpt X. Their clinical data were prospectively registered. Major adverse cardiac events (MACE) were defined as a composite of cardiac death, stent thrombosis, nonfatal myocardial infarction, target lesion revascularization (TLR) and target vessel revascularization (TVR).

Results
Overall, 87 real-world patients and 93 lesions (73% male, 68±10 years, 46% smoker, 83% hypertensive, 62% diabetic, 71% hyperlipidemic, 35% LVEF &lt;60% impairment) were enrolled in the study. Clinical presentation was stable angina in 19%, unstable angina in 33%, NSTEMI in 29% and STEMI in 5%. Radial access account 84%. The median fluoroscopy time was 17 (IQ range 10,0 - 37.5) min. De novo complex lesions were treated in 35% (n=32) while ISR in 63% (n=57), (Prior BMS 19%; Sirolimus DES 9%; Everolimus DES 26%; Biolimus/Anfilimus DES 20%; Zotarolimus DES 26%) with a median time to ISR of 3.6 (IQ range 1.1 - 10.7) years. Total stent length was 28±18 mm, with an overlap spot affected in 18%, and 27% had &gt;1 treatment for ISR. The most frequent artery treated was left anterior descending (41%) followed by left circumflex (35%) and right coronary artery (17%).
Quantitative coronary angiography reference diameter of lesions was 2.7±0.5 mm and length 9.0±4.8 mm, with a % stenosis of 75±20. Predilatation/postdilatation was performed in 60/24% respectively. Device diameter was 2.9±0.4 mm and length 13.6±3.9 mm, deployed at 16±3 atmospheres, with an inflation time of 33±16 seconds. The balloon/artery ratio was 0.99±0.03. Crossover was decided on 18 cases (19%) due to remaining intimal flap, but the success rate (residual stenosis &lt;30%) was 100%. Intracoronary imaging technique was performed in 12% (OCT=7, IVUS=4). At 7±6 month follow-up, there were 10 MACE (cardiac death=1, nonfatal myocardial infarction =4, TLR=4 and TVR=1).

Conclusions
Paclitaxel-coated scoring balloon offers a safe and valuable treatment option for ISR and de novo complex lesions.

Funding Acknowledgement
Type of funding source: Public hospital(s). Main funding source(s): Juan Ramόn Jiménez University Hospital
5-year outcomes in patients with acute coronary syndrome treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents
Authors: Iglesias J.F , Heg D , Roffi M , Tueller D , Muller O , Moarof I , Cook S , Weilenmann D , Kaiser C , Valgimigli M , Juni P , Windecker S , Pilgrim T 
Published: November 2020

Abstract

Background
Newest generation drug-eluting stents (DES) combining ultrathin cobalt chromium platforms with biodegradable polymers may reduce target lesion failure (TLF) as compared to second generation DES among patients with acute coronary syndrome (ACS). While previous studies indicated a potential benefit within the first two years after percutaneous coronary intervention (PCI), it remains uncertain whether the clinical benefit persists after complete degradation of the polymer coating.

Purpose
To compare the long-term effects of ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) versus thin-strut durable polymer everolimus-eluting stents (DP-EES) for PCI in patients with ACS.

Methods
We performed a subgroup analysis of ACS patients included into the BIOSCIENCE trial (NCT01443104), a randomized trial comparing BP-SES with DP-EES. The primary endpoint of the present post-hoc analysis was TLF, a composite of cardiac death, target vessel myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR), at 5 years.

Results
Among 2,119 patients enrolled between March 2012 and May 2013, 1,131 (53%) presented with ACS (ST-segment elevation myocardial infarction, 36%). Compared to patients with stable CAD, ACS patients were younger, had a lower baseline cardiac risk profile, including a lower prevalence of hypertension, hypercholesterolaemia, diabetes mellitus, and peripheral artery disease, and had a greater incidence of previous revascularization procedures. At 5 years, TLF occurred similarly in 89 patients (cumulative incidence, 16.9%) treated with BP-SES and 85 patients (16.0%) treated with DP-EES (RR 1.04; 95% CI 0.78–1.41; p=0.78) in patients with ACS, and in 109 patients (24.1%) treated with BP-SES and 104 patients (21.8%) treated with DP-EES (RR 1.11; 95% CI 0.85–1.45; p=0.46) in stable CAD patients (p for interaction=0.77) (Figure 1, Panel A). Cumulative incidences of cardiac death (8% vs. 7%; p=0.66), target vessel MI (5.2% vs. 5.8%; p=0.66), clinically indicated TLR (8.9% vs. 8.3%; p=0.63) (Figure 1, Panel B-D), and definite thrombosis (1.4% vs. 1.0%; p=0.57) at 5 years were similar among ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Overall, there was no interaction between clinical presentation and treatment effect of BP-SES versus DP-EES.

Conclusion
In a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term clinical outcomes between ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES at five years.

Funding Acknowledgement
Type of funding source: Private company. Main funding source(s): Unrestricted research grant to the institution from Biotronik AG, Switzerland
Provisional versus 2-stent strategies for coronary bifurcations: is a bird in the hand worth two in the bush?
Authors: Sousa J.P , Puga L , Ribeiro J , Lopes J , Saleiro C , Gomes R , Campos D , Lourenco C , Goncalves L 
Published: November 2020

Abstract

Background
Among all subsets of coronary artery lesions, bifurcations stand out due to high incidence, demanding percutaneous interventions (PCIs) and poor outcomes. Amid the different PCI strategies, the provisional (PS) approach is generally recommended over 2-stent (TS) techniques, but this paradigm has been challenged.

Purpose
To compare PS with TS for PCI of coronary bifurcation lesions, concerning procedural aspects and both immediate and long-term patient outcomes.

Methods
Retrospective study encompassing patients consecutively referred to a tertiary interventional cardiology unit for coronary angiography, who were found to have at least 1 native bifurcation lesion. According to operator experience and angiographic features, patients were managed with PS or/(and) TS. Procedural aspects regarding radiological variables, angiographic success and immediate complications were reviewed, as were in-hospital outcomes. Besides, clinical follow-up, by clinic appointment or telephone calling, was performed targeting stent failure, target vessel revascularization (TVR), acute coronary syndromes (ACS), heart failure and mortality.

Results
From January 2010 to June 2017, 404 patients with 433 bifurcation lesions were included. Median age was 70 (62–77) years and 25.3% were female. Median follow-up was 2 (1–3) years. Chronic angina was the dominant PCI context (61.3%) with 9.7% presenting with ST-segment elevation myocardial infarction (MI). Medina class 1,1,1 was documented in 54.1% and 64.9% of lesions were hailed as true bifurcations. 303 patients underwent PS, whereas 67 were managed with TS, with TAP (43.3%) and mini-crush (34.3%) as the leading techniques. True bifurcations were more frequently approached with TS (p&lt;0.001), whereas PCI context did not influence procedure selection. Fluoroscopy time (p&lt;0.001), radiation dose (p=0.003) and contrast volume (p=0.009) were higher in the TS subgroup. OCT guidance (p=0.039) was also more common with TS. Angiographic success was uniformly high (95.1% for PS and 97% for TS), while procedural complications, including iatrogenic coronary dissections (7.4%, mostly minor) and slow-reflow (3.5%), were homogenously low. Acute kidney injury and type 4a MI occurred in 14.5% and 32.3%, respectively, also with no difference between groups. As for long-term outcomes, stent failure, encompassing both stent thrombosis (1 event) and restenosis (4.2%), occurred more often with TS (p=0.046), with ACS events (9.5%) following the same trend (p=0.08). In turn, rates of TVR (12.5%), heart failure hospitalization (6.2%) and mortality, regardless of its cardiovascular nature, were similar.

Conclusion
PS outperforms TS during follow-up, particularly due to lower stent failure odds. Thus, this study further supports the concept of PS as the standard approach for coronary bifurcation lesions.

Funding Acknowledgement
Type of funding source: None
Complete versus culprit-only percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndrome: a meta-analysis
Authors: Sakurai R 
Published: November 2020

Abstract

Background
The clinical benefit of complete or culprit-only percutaneous coronary intervention (PCI) in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) still remains controversial.

Purpose
The purpose of this study was to investigate the clinical outcomes of complete or culprit-only PCI in patients with unstable angina and/or non-ST-segment elevation myocardial infarction.

Methods
PubMed, the Cochrane Library, and Web of Science were queried to conduct a meta-analysis. The same terms or relevant studies were also queried on the website of the U.S. National Institute of Health and relevant reviews. The primary endpoint was the incidence of major adverse cardiac events (MACE: the composite of all-cause mortality, myocardial infarction, or coronary revascularisation) during follow-up period, and the secondary endpoints were the incidences of each component of MACE. When multiple follow-up results were reported in the same study, the latest results were abstracted. Pooled estimates were calculated using a random-effects model.

Results
Nine studies (60345 patients) were included in this meta-analysis. The risk of all-cause mortality (odds ratio (OR): 0.79, 95% confidence interval (CI): 0.64–0.98, p=0.03) or coronary revascularisation (OR: 0.71, 95% CI: 0.50–1.00, p=0.05) were lower in the complete PCI group than in the culprit-only PCI group, whereas the risk of MACE (OR: 0.98, 95% CI: 0.65–1.49, p=0.94) or myocardial infarction (OR: 0.77, 95% CI: 0.54–1.08, p=0.13) was similar between the 2 groups.

Conclusions
In this meta-analysis, complete PCI is associated with a lower risk of all-cause mortality or coronary revascularisation, and a similar risk of MACE or myocardial infarction compared with culprit-only PCI in patients with NSTE-ACS.

Funding Acknowledgement
Type of funding source: None