用于经皮冠状动脉血运重建的超薄支柱可生物降解聚合物西罗莫司洗脱支架与耐用聚合物依维莫司洗脱支架对比：BIOSCIENCE试验的2年结果

Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable-Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularization: 2-Year Results of the BIOSCIENCE Trial.

作者信息

Zbinden Rainer, Piccolo Raffaele, Heg Dik, Roffi Marco, Kurz David J, Muller Olivier, Vuilliomenet André, Cook Stéphane, Weilenmann Daniel, Kaiser Christoph, Jamshidi Peiman, Franzone Anna, Eberli Franz, Jüni Peter, Windecker Stephan, Pilgrim Thomas

机构信息

Department of Cardiology, Triemlispital, Zurich, Switzerland.

Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland.

出版信息

J Am Heart Assoc. 2016 Mar 15;5(3):e003255. doi: 10.1161/JAHA.116.003255.

DOI:10.1161/JAHA.116.003255

PMID:26979080

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4943287/

Abstract

BACKGROUND

No data are available on the long-term performance of ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES). We reported 2-year clinical outcomes of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularisation) trial, which compared BP-SES with durable-polymer everolimus-eluting stents (DP-EES) in patients undergoing percutaneous coronary intervention.

METHODS AND RESULTS

A total of 2119 patients with minimal exclusion criteria were assigned to treatment with BP-SES (n=1063) or DP-EES (n=1056). Follow-up at 2 years was available for 2048 patients (97%). The primary end point was target-lesion failure, a composite of cardiac death, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. At 2 years, target-lesion failure occurred in 107 patients (10.5%) in the BP-SES arm and 107 patients (10.4%) in the DP-EES arm (risk ratio [RR] 1.00, 95% CI 0.77-1.31, P=0.979). There were no significant differences between BP-SES and DP-EES with respect to cardiac death (RR 1.01, 95% CI 0.62-1.63, P=0.984), target-vessel myocardial infarction (RR 0.91, 95% CI 0.60-1.39, P=0.669), target-lesion revascularization (RR 1.17, 95% CI 0.81-1.71, P=0.403), and definite stent thrombosis (RR 1.38, 95% CI 0.56-3.44, P=0.485). There were 2 cases (0.2%) of definite very late stent thrombosis in the BP-SES arm and 4 cases (0.4%) in the DP-EES arm (P=0.423). In the prespecified subgroup of patients with ST-segment elevation myocardial infarction, BP-SES was associated with a lower risk of target-lesion failure compared with DP-EES (RR 0.48, 95% CI 0.23-0.99, P=0.043, Pinteraction=0.026).

CONCLUSIONS

Comparable safety and efficacy profiles of BP-SES and DP-EES were maintained throughout 2 years of follow-up.

CLINICAL TRIAL REGISTRATION

URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104.

摘要

背景

关于超薄支柱可生物降解聚合物西罗莫司洗脱支架（BP-SES）的长期性能尚无数据。我们报告了BIOSCIENCE（超薄支柱可生物降解聚合物西罗莫司洗脱支架与耐用聚合物依维莫司洗脱支架用于经皮冠状动脉血运重建）试验的2年临床结果，该试验在接受经皮冠状动脉介入治疗的患者中比较了BP-SES与耐用聚合物依维莫司洗脱支架（DP-EES）。

方法和结果

共有2119例排除标准极低的患者被分配接受BP-SES治疗（n = 1063）或DP-EES治疗（n = 1056）。2048例患者（97%）获得了2年的随访。主要终点是靶病变失败，这是一个包括心源性死亡、靶血管心肌梗死或临床指征的靶病变血运重建的复合终点。2年时，BP-SES组有107例患者（10.5%）发生靶病变失败，DP-EES组有107例患者（10.4%）发生靶病变失败（风险比[RR] 1.00，95%置信区间0.77 - 1.31，P = 0.979）。BP-SES和DP-EES在心源性死亡（RR 1.01，95%置信区间0.62 - 1.63，P = 0.984）、靶血管心肌梗死（RR 0.91，95%置信区间0.60 - 1.39，P = 0.669）、靶病变血运重建（RR 1.17，95%置信区间0.81 - 1.71，P = 0.403）和明确的支架血栓形成（RR 1.38，95%置信区间0.56 - 3.44，P = 0.485）方面无显著差异。BP-SES组有2例（0.2%）明确的极晚期支架血栓形成，DP-EES组有4例（0.4%）（P = 0.423）。在预先设定的ST段抬高型心肌梗死患者亚组中，与DP-EES相比，BP-SES与较低的靶病变失败风险相关（RR 0.48，95%置信区间0.23 - 0.99，P = 0.043，P交互作用 = 0.026）。