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经皮冠状动脉介入治疗中氯吡格雷用药时间对 DES 和 BMS 疗效的影响:随机试验的荟萃回归分析。

Impact of duration of clopidogrel prescription on outcome of DES as compared to BMS in primary angioplasty: a meta-regression analysis of randomized trials.

机构信息

Division of Cardiology, Ospedale Maggiore della Carità, Eastern Piedmont University, C.so Mazzini, 18, 24100 Novara, Italy.

出版信息

J Thromb Thrombolysis. 2009 May;27(4):365-78. doi: 10.1007/s11239-008-0223-0. Epub 2008 May 23.

Abstract

AIMS

Recent concerns have emerged on the potential higher risk of stent thrombosis after Drug-eluting stents (DES) implantation, that might be even more pronounced among ST-segment elevation myocardial infarction (STEMI) patients. The aim of the current study was to evaluate, by a meta-analytic approach, whether the benefits and safety of DES as compared to bare-metal stents (BMS) in patients undergoing primary angioplasty for STEMI may be influenced by the duration of prescription of dual oral antiplatelet therapy.

METHODS

The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL). We examined all completed randomized trials of DES for STEMI. The following key words were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, stenting, DES, sirolimus-eluting stent (SES), Cypher, paclitaxel-eluting stent (PES), Taxus. Information on study design, type of stent, inclusion and exclusion criteria, primary endpoint, number of patients, angiographic and clinical outcome, were extracted by two investigators. Disagreements were resolved by consensus.

RESULTS

A total of 12 trials were included in the meta-analysis, involving 4,351 patients (2,260 or 51.9% randomized to DES and 2,091 or 48.1% randomized to BMS). In five trials (involving 1690 patients) dual oral antiplatelet therapy was prescribed for at least 1 year. The outcome of DES as compared to BMS was not affected by the duration of dual antiplatelet therapy in terms of death (P interaction = 0.16), reinfarction (P interaction = 0.91) and in-stent thrombosis (P interaction = 0.26) and TVR (P interaction = 0.38). These data were confirmed by the use of a meta-regression analysis.

CONCLUSIONS

This meta-analysis shows that among selected STEMI patients undergoing primary angioplasty, DES (SES and PES), as compared to BMS, are safe and their benefits are not affected by the duration of clopidogrel prescription.

摘要

目的

最近有研究对药物洗脱支架(DES)植入后支架血栓形成的风险增加表示担忧,而在 ST 段抬高型心肌梗死(STEMI)患者中这种风险可能更为明显。本研究旨在通过荟萃分析评估与裸金属支架(BMS)相比,DES 在接受直接经皮冠状动脉介入治疗(PCI)的 STEMI 患者中的获益和安全性是否会受到双重抗血小板治疗持续时间的影响。

方法

通过正式检索电子数据库(MEDLINE 和 CENTRAL)对文献进行扫描。我们检查了所有关于 DES 治疗 STEMI 的完成随机试验。使用以下关键词进行研究选择:随机试验、心肌梗死、再灌注、直接 PCI、支架置入、DES、西罗莫司洗脱支架(SES)、Cypher、紫杉醇洗脱支架(PES)、Taxus。两名研究者提取了研究设计、支架类型、纳入和排除标准、主要终点、患者数量、血管造影和临床结果等信息。分歧通过协商解决。

结果

荟萃分析共纳入 12 项试验,涉及 4351 例患者(2260 例或 51.9%随机分配至 DES 组,2091 例或 48.1%随机分配至 BMS 组)。在 5 项试验(涉及 1690 例患者)中,双重抗血小板治疗至少持续 1 年。DES 与 BMS 相比,在死亡(P 交互=0.16)、再梗死(P 交互=0.91)、支架内血栓形成(P 交互=0.26)和靶血管血运重建(TVR)(P 交互=0.38)方面,双重抗血小板治疗的持续时间对结果无影响。使用荟萃回归分析也证实了这些数据。

结论

本荟萃分析表明,在接受直接 PCI 的选定 STEMI 患者中,与 BMS 相比,DES(SES 和 PES)是安全的,且其获益不受氯吡格雷用药时间的影响。

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