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药物洗脱支架在ST段抬高型心肌梗死中的疗效与安全性:随机试验的荟萃分析

Efficacy and safety of drug-eluting stents in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials.

作者信息

De Luca Giuseppe, Stone Gregg W, Suryapranata Harry, Laarman Gerrit Jan, Menichelli Maurizio, Kaiser Christoph, Valgimigli Marco, Di Lorenzo Emilio, Dirksen Maurits T, Spaulding Christian, Pittl Undine, Violini Roberto, Percoco Gianfranco, Marino Paolo

机构信息

Division of Cardiology, Ospedale Maggiore della Carità, Eastern Piedmont University, Novara, Italy.

出版信息

Int J Cardiol. 2009 Apr 3;133(2):213-22. doi: 10.1016/j.ijcard.2007.12.040. Epub 2008 Apr 3.

Abstract

BACKGROUND

Recent concerns have emerged on the potential higher risk of stent thrombosis after DES implantation, that might be even more pronounced among STEMI patients. Thus, the aim of the current study was to perform a meta-analysis to evaluate the benefits and safety of DES as compared to BMS in patients undergoing primary angioplasty for STEMI.

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 11 trials were included in the meta-analysis, involving 3605 patients (1888 or 52.3% randomized to DES and 1719 or 47.7% randomized to BMS). At 12 months follow-up, no significant difference was observed in mortality (4.1% vs 4.4%, OR [95% CI]=0.91 [0.66-1.27], p=0.59, reinfarction (3.1% vs 3.4%, OR [95% CI]=0.85 [0.58, 1.23], p=0.38 or stent thrombosis (1.6% vs 2.2%, OR [95% CI]=0.76 [0.47, 1.23], p=0.22), whereas DES were associated with a significant reduction in TVR (5.0% vs 12.6%, OR [95% CI]=0.36 [0.28, 0.47], p<0.0001). Safety and efficacy of DES were confirmed at 18 to 24 months follow-up (data available from 4 trials including 1178 patients).

CONCLUSIONS

This meta-analysis shows that among selected STEMI patients undergoing primary angioplasty, SES and PES, as compared to BMS, are safe and associated with a significant reduction in TVR at 1 and 2 years follow-up.

摘要

背景

近期人们开始关注药物洗脱支架(DES)植入术后支架血栓形成的潜在高风险,这在ST段抬高型心肌梗死(STEMI)患者中可能更为明显。因此,本研究的目的是进行一项荟萃分析,以评估在接受STEMI直接血管成形术的患者中,DES与裸金属支架(BMS)相比的获益和安全性。

方法

通过正式检索电子数据库(MEDLINE和CENTRAL)来筛选文献。我们审查了所有已完成的针对STEMI的DES随机试验。以下关键词用于研究选择:随机试验、心肌梗死、再灌注、直接血管成形术、支架置入、DES、西罗莫司洗脱支架(SES)、Cypher、紫杉醇洗脱支架(PES)、Taxus。两名研究者提取了关于研究设计、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的信息。分歧通过协商解决。

结果

荟萃分析共纳入11项试验,涉及3605例患者(1888例或52.3%随机分配至DES组,1719例或47.7%随机分配至BMS组)。在12个月的随访中,死亡率(4.1%对4.4%,OR[95%CI]=0.91[0.66 - 1.27],p = 0.59)、再梗死率(3.1%对3.4%,OR[95%CI]=0.85[0.58, 1.23],p = 0.38)或支架血栓形成率(1.6%对2.2%,OR[95%CI]=0.76[0.47, 1.23],p = 0.22)均未观察到显著差异,而DES与靶病变血运重建(TVR)显著降低相关(5.0%对12.6%,OR[95%CI]=0.36[0.28, 0.47],p<0.0001)。在18至24个月的随访中(4项试验共1178例患者的数据可用),DES的安全性和有效性得到证实。

结论

这项荟萃分析表明,在接受直接血管成形术的特定STEMI患者中,与BMS相比,SES和PES在1年和2年随访时是安全的,并且与TVR显著降低相关。

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