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依维莫司洗脱支架与西罗莫司洗脱支架:随机试验的荟萃分析。

Everolimus-eluting versus sirolimus-eluting stents: a meta-analysis of randomized trials.

机构信息

Deutsches Herzzentrum and 1 Med Klinik rechts der Isar, Technische Universität, Lazarettstrasse 36, Munich, Germany.

出版信息

Circ Cardiovasc Interv. 2011 Aug;4(4):371-7. doi: 10.1161/CIRCINTERVENTIONS.111.963256. Epub 2011 Jul 26.

DOI:10.1161/CIRCINTERVENTIONS.111.963256
PMID:21791671
Abstract

BACKGROUND

The aim of the study was to compare the outcomes after placement of the everolimus-eluting stent (EES; Xience V) and the sirolimus-eluting stent (SES; Cypher) in patients with coronary artery disease. The second-generation EES is currently one of the most commonly used drug-eluting stents in clinical practice. Although it has clearly been shown superior to paclitaxel-eluting stents, its relative merits against SES have been less extensively assessed.

METHODS AND RESULTS

We identified 5 eligible randomized trials comparing EES with SES in 7370 patients. The primary end point was major adverse cardiac events. Secondary end points were cardiac death, myocardial infarction, repeat revascularization, and the composite of definite and probable stent thrombosis. Overall hazard ratios (HR) and 95% confidence intervals (CI) were calculated for EES versus SES for each of the end points. No heterogeneity across the trials was observed regarding the primary and secondary end points. The risk of major adverse cardiac events (HR, 0.91 [95% CI, 0.77 to 1.08]; P=0.28), cardiac death (HR, 1.02 [95% CI, 0.73 to 1.41]; P=0.92), myocardial infarction (HR, 0.97 [95% CI, 0.66 to 1.35]; P=0.76), repeat revascularization (HR, 0.85 [95% CI, 0.68 to 1.07]; P=0.16), and composite of definite and probable stent thrombosis (HR, 0.79 [95% CI, 0.49 to 1.27], P=0.33) were not significantly different between EES and SES.

CONCLUSIONS

This meta-analysis did not show significant differences between EES and SES in terms of clinical efficacy and safety. Future studies with longer follow-up are needed to better define the relative merits of these drug-eluting stents.

摘要

背景

本研究旨在比较在患有冠状动脉疾病的患者中使用依维莫司洗脱支架(EES;Xience V)和西罗莫司洗脱支架(SES;Cypher)的结果。第二代 EES 目前是临床实践中最常使用的药物洗脱支架之一。尽管它已明显优于紫杉醇洗脱支架,但对其相对于 SES 的优势评估却较少。

方法和结果

我们确定了 5 项比较 EES 与 SES 在 7370 例患者中的疗效的随机试验。主要终点为主要不良心脏事件。次要终点为心脏死亡、心肌梗死、再次血运重建和确定及可能的支架血栓形成的复合终点。为 EES 与 SES 之间的每个终点计算了总体危险比(HR)和 95%置信区间(CI)。各试验中,主要和次要终点均未观察到异质性。主要不良心脏事件(HR,0.91 [95%CI,0.77 至 1.08];P=0.28)、心脏死亡(HR,1.02 [95%CI,0.73 至 1.41];P=0.92)、心肌梗死(HR,0.97 [95%CI,0.66 至 1.35];P=0.76)、再次血运重建(HR,0.85 [95%CI,0.68 至 1.07];P=0.16)和确定及可能的支架血栓形成的复合终点(HR,0.79 [95%CI,0.49 至 1.27],P=0.33)在 EES 和 SES 之间无显著差异。

结论

本荟萃分析并未显示 EES 和 SES 在临床疗效和安全性方面有显著差异。需要进行随访时间更长的未来研究,以更好地确定这些药物洗脱支架的相对优势。

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