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来自PROENCY(普罗米修斯依维莫司洗脱支架与佐他莫司洗脱支架或西罗莫司洗脱支架对比研究)注册研究的经皮冠状动脉介入治疗后使用依维莫司洗脱支架与佐他莫司洗脱支架或西罗莫司洗脱支架的12个月结果比较。

Comparison of twelve-month outcomes after percutanous coronary intervention with everolimus-eluting versus zotarolimus-eluting or sirolimus-eluting stents from the PROENCY (PROmus ENdeavor CYpher) registry.

作者信息

Damman Peter, Abdel-Wahab Mohamed, Möllmann Helge, Richardt Gert, Chevalier Bernard, Barragan Paul, Tijssen Jan G P, Underwood Paul, Hamm Christian W

机构信息

Kerckhoff Heart and Thorax Center, Benekestrasse 2-8, 61231 Bad Nauheim, Germany.

出版信息

J Invasive Cardiol. 2012 Oct;24(10):495-502.

Abstract

OBJECTIVES

We compared safety and efficacy outcomes of 3 limus-based drug-eluting stents in the 'all-comers' PROENCY (PROmus/ENdeavor/CYpher) registry.

BACKGROUND

Limited data are available on head-to-head comparisons of the everolimus-eluting stent (EES) with the zotarolimus-eluting stent (ZES) or the sirolimus- eluting stent (SES) in the treatment of patients with coronary artery disease.

METHODS

PROENCY was a prospective, open-label, multicenter, observational study including consecutive patients undergoing planned treatment with EES, ZES, or SES. Seventeen centers were designated to place an EES or SES, 14 other centers were designated to place EES or ZES. The primary endpoint was the composite of cardiac death, myocardial infarction, and target vessel revascularization (TVR) at 12 months. Unadjusted and propensity-adjusted outcomes were compared between groups.

RESULTS

A total of 1921 patients were enrolled in the study from February to December 2008, of which 1704 patients received only study stents and were analyzed. At 12 months, the unadjusted major adverse event rate was significantly lower in the EES group versus the ZES group (3.1% vs 8.7%; P=.001) and the SES group (5.2% vs 9.6%; P=.01). This was mainly driven by lower TVR rates [2.6% with EES vs 8.2% with ZES [P<.001] and 4.1% with EES vs 7.0% with SES [P=.05]. Stent thrombosis rates were low and comparable. Adjusted analyses confirmed the unadjusted results.

CONCLUSION

There were no differences in safety outcomes of EES, ZES, and SES at 12 months in PROENCY. However, differences in efficacy were observed between the 3 "limus"-based stents in a real-world patient population.

摘要

目的

我们在“所有患者”的PROENCY(百慕大/安珂/西罗莫司洗脱支架)注册研究中比较了3种基于雷帕霉素的药物洗脱支架的安全性和有效性结果。

背景

关于依维莫司洗脱支架(EES)与佐他莫司洗脱支架(ZES)或西罗莫司洗脱支架(SES)在治疗冠状动脉疾病患者方面进行直接比较的数据有限。

方法

PROENCY是一项前瞻性、开放标签、多中心、观察性研究,纳入了连续接受EES、ZES或SES计划治疗的患者。17个中心被指定植入EES或SES,另外14个中心被指定植入EES或ZES。主要终点是12个月时的心源性死亡、心肌梗死和靶血管重建(TVR)的复合终点。对组间未调整和倾向调整后的结果进行了比较。

结果

2008年2月至12月共有1921例患者纳入研究,其中1704例患者仅接受了研究支架并进行了分析。12个月时,EES组未调整的主要不良事件发生率显著低于ZES组(3.1%对8.7%;P = 0.001)和SES组(5.2%对9.6%;P = 0.01)。这主要是由较低的TVR率驱动的[EES为2.6%,ZES为8.2%[P < 0.001],EES为4.1%,SES为7.0%[P = 0.05]。支架血栓形成率较低且相当。调整分析证实了未调整的结果。

结论

在PROENCY研究中,EES、ZES和SES在12个月时的安全性结果没有差异。然而,在真实世界的患者群体中,观察到这3种基于“雷帕霉素”的支架在有效性方面存在差异。

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