常规临床实践中生物可降解聚合物涂层雷帕霉素洗脱支架与永久性聚合物涂层西罗莫司洗脱支架随机比较的 2 年临床随访。

2-year clinical follow-up from the randomized comparison of biolimus-eluting stents with biodegradable polymer and sirolimus-eluting stents with durable polymer in routine clinical practice.

机构信息

Department of Cardiology, University Hospital Munich (Innenstadt), Munich, Germany.

出版信息

JACC Cardiovasc Interv. 2011 Aug;4(8):887-95. doi: 10.1016/j.jcin.2011.03.017.

DOI:10.1016/j.jcin.2011.03.017

PMID:21851904

Abstract

OBJECTIVES

This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with biodegradable polymer as compared with sirolimus-eluting stents (SES) with durable polymer through 2 years of follow-up.

BACKGROUND

BES with a biodegradable polymer provide similar efficacy and safety as SES with a durable polymer at 9 months. Clinical outcomes beyond the period of biodegradation of the polymer used for drug release and after discontinuation of dual antiplatelet therapy are of particular interest.

METHODS

A total of 1,707 patients were randomized to unrestricted use of BES (n = 857) or SES (n = 850) in an all-comers patient population.

RESULTS

At 2 years, BES remained noninferior compared with SES for the primary endpoint, which was a composite of cardiac death, myocardial infarction, or clinically indicated target vessel revascularization (BES 12.8% vs. SES 15.2%, hazard ratio [HR]: 0.84, 95% confidence interval [CI]: 0.65 to 1.08, p(noninferiority) < 0.0001, p(superiority) = 0.18). Rates of cardiac death (3.2% vs. 3.9%, HR: 0.81, 95% CI: 0.49 to 1.35, p = 0.42), myocardial infarction (6.3% vs. 5.6%, HR: 1.12, 95% CI: 0.76 to 1.65, p = 0.56), and clinically indicated target vessel revascularization (7.5% vs. 8.6%, HR: 0.86, 95% CI: 0.62 to 1.20, p = 0.38) were similar for BES and SES. The rate of definite stent thrombosis through 2 years was 2.2% for BES and 2.5% for SES (p = 0.73). For the period between 1 and 2 years, event rates for definite stent thrombosis were 0.2% for BES and 0.5% for SES (p = 0.42). After discontinuation of dual antiplatelet therapy, no very late definite stent thrombosis occurred in the BES group.

CONCLUSIONS

At 2 years of follow-up, the unrestricted use of BES with a biodegradable polymer maintained a similar safety and efficacy profile as SES with a durable polymer. (Limus Eluted From a Durable Versus Erodable Stent Coating [LEADERS]; NCT00389220).

摘要

目的

本研究旨在通过 2 年的随访，比较生物可降解聚合物涂层雷帕霉素洗脱支架（BES）与永久性聚合物涂层西罗莫司洗脱支架（SES）的安全性和疗效。

背景

在 9 个月时，BES 与永久性聚合物涂层 SES 的疗效和安全性相当，而聚合物用于药物释放的生物降解期结束后和双联抗血小板治疗停止后的临床结果尤其令人关注。

方法

共 1707 例患者随机分为无限制使用 BES（n=857）或 SES（n=850）的全患者人群。

结果

2 年时，BES 组的主要终点（心脏死亡、心肌梗死或临床需要靶血管血运重建的复合终点）非劣效于 SES 组（BES 为 12.8%，SES 为 15.2%，风险比[HR]：0.84，95%置信区间[CI]：0.65 至 1.08，p（非劣效性）<0.0001，p（优效性）=0.18）。心脏死亡发生率（3.2% vs. 3.9%，HR：0.81，95%CI：0.49 至 1.35，p=0.42）、心肌梗死发生率（6.3% vs. 5.6%，HR：1.12，95%CI：0.76 至 1.65，p=0.56）和临床需要靶血管血运重建发生率（7.5% vs. 8.6%，HR：0.86，95%CI：0.62 至 1.20，p=0.38）在 BES 和 SES 两组间相似。BES 组和 SES 组 2 年时明确支架血栓形成的发生率分别为 2.2%和 2.5%（p=0.73）。在 1 至 2 年期间，BES 组和 SES 组明确支架血栓形成的发生率分别为 0.2%和 0.5%（p=0.42）。停止双联抗血小板治疗后，BES 组未发生晚期明确支架血栓形成。