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药物洗脱支架置入术后长期双重抗血小板治疗的获益与风险:一项随机试验的荟萃分析

Benefits and risks of long-term duration of dual antiplatelet therapy after drug-eluting stenting: a meta-analysis of randomized trials.

作者信息

Valgimigli Marco, Park Seung-Jung, Kim Hyo-Soo, Park Kyung Woo, Park Duk-Woo, Tricoci Pierluigi, Ferrante Giuseppe

机构信息

Cardiology Department, University of Ferrara, Italy.

出版信息

Int J Cardiol. 2013 Oct 3;168(3):2579-87. doi: 10.1016/j.ijcard.2013.03.047. Epub 2013 Apr 13.

DOI:10.1016/j.ijcard.2013.03.047
PMID:23590932
Abstract

BACKGROUND

The potential benefits and risks of at least 1-year dual antiplatelet therapy (DAPT) duration after drug-eluting stent (DES) implantation remain uncertain.

METHODS AND RESULTS

PubMed, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched from database inception to December 2011 for randomized controlled trials that compared longer DAPT versus shorter DAPT duration after DES. Unpublished data were obtained from investigators. Trial-specific odds ratios (ORs) with 95% confidence interval (CI) were calculated and pooled using fixed-effects or random-effects model as appropriate. Data were independently extracted by 2 reviewers. Three randomized controlled trials comprising 5622 participants were included. Compared with patients receiving short-term therapy, participants receiving longer DAPT duration had a pooled OR of 1.26 (95% CI, 0.88 to 1.80; P=0.21, random-effects) for the primary outcome of cardiac death, myocardial infarction or stroke, OR of 1.29 (95% CI, 0.85 to 1.93; fixed-effects) for all-cause death, 1.23 (95% CI, 0.78 to 1.93; fixed-effects) for cardiac death, 0.91 (95% CI, 0.58 to 1.42; random-effects) for myocardial infarction, 1.93 (95% CI, 1.01 to 3.69; fixed-effects) for stroke and 2.51 (95% CI, 1.10 to 5.71, fixed-effects) for TIMI major bleeding. The number needed to treat for an additional harmful outcome was 217.6 for stroke and 243 for TIMI major bleeding.

CONCLUSIONS

This meta-analysis provides no evidence of benefits with longer DAPT duration as compared with a shorter course of therapy. It also reports significant harms with respect to major bleeding and stroke associated with prolonged DAPT use.

摘要

背景

药物洗脱支架(DES)植入术后至少1年的双重抗血小板治疗(DAPT)疗程的潜在益处和风险仍不确定。

方法与结果

检索了PubMed、Cochrane对照试验中央注册库和ClinicalTrials.gov数据库,从建库至2011年12月,查找比较DES植入术后较长DAPT疗程与较短DAPT疗程的随机对照试验。未发表的数据从研究者处获取。计算特定试验的比值比(OR)及其95%置信区间(CI),并根据情况使用固定效应或随机效应模型进行汇总。数据由2名审阅者独立提取。纳入了3项随机对照试验,共5622名参与者。与接受短期治疗的患者相比,接受较长DAPT疗程的参与者发生心源性死亡、心肌梗死或卒中这一主要结局的合并OR为1.26(95%CI,0.88至1.80;P=0.21,随机效应),全因死亡的OR为1.29(95%CI,0.85至1.93;固定效应),心源性死亡的OR为1.23(95%CI,0.78至1.93;固定效应),心肌梗死的OR为0.91(95%CI,0.58至1.42;随机效应);卒中的OR为1.93(95%CI,1.01至3.69;固定效应),TIMI大出血的OR为2.51(95%CI,1.10至5.71,固定效应)。因额外有害结局而需要治疗的人数,卒中为217.6,TIMI大出血为243。

结论

这项荟萃分析没有提供证据表明较长DAPT疗程比短疗程治疗更有益。它还报告了长期使用DAPT与大出血和卒中相关的显著危害。

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