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药物洗脱支架置入术后延长双联抗血小板治疗:随机试验的荟萃分析

Prolonged dual antiplatelet therapy after drug-eluting stenting: meta-analysis of randomized trials.

作者信息

Cassese Salvatore, Byrne Robert A, Ndrepepa Gjin, Schunkert Heribert, Fusaro Massimiliano, Kastrati Adnan

机构信息

Deutsches Herzzentrum München, Technische Universität München, (SC, RAB, GN, HS, MF, AK) and DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, (HS, AK), Lazarettstr. 36, Munich, Germany.

出版信息

Clin Res Cardiol. 2015 Oct;104(10):887-901. doi: 10.1007/s00392-015-0860-1. Epub 2015 Apr 23.

DOI:10.1007/s00392-015-0860-1
PMID:25903112
Abstract

AIMS

To investigate the benefits and the risks of a prolonged duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation.

METHODS AND RESULTS

Electronic scientific databases were searched for randomized trials investigating the clinical impact of prolonged versus control DAPT duration in patients receiving a PCI with DES implantation. Primary outcomes were the incidence of stent thrombosis (ST), major bleeding and death. Secondary outcomes were the incidence of cardiac death, myocardial infarction (MI) and cerebrovascular event (CVE). The main analysis evaluated the primary outcomes by including events that occurred whereas therapies in the treatment groups actually differed. Events occurred at the longest follow-up available for each included trial contributed to risk estimates in a separate analysis. Odds ratio (95 % confidence interval) served as summary statistic. Ten trials totaling 32,194 participants were included in the meta-analysis. Median DAPT duration was 15 (12-24) versus 6 (6-12) months for the prolonged and control DAPT groups, respectively. After a median follow-up of 19.5 months, a prolonged versus control DAPT reduces the risk of ST [0.50 (0.29-0.85), P = 0.01] and MI [0.55 (0.45-0.67), P < 0.001], at the expense of higher risk of major bleeding [1.67 (1.31-2.13), P < 0.001] and death [1.25 (1.02-1.53), P = 0.03]. A prolonged versus control DAPT does not influence the risk of cardiac death [1.08 (0.82-1.44), P = 0.74] or CVE [0.84 (0.57-1.24), P = 0.39].

CONCLUSIONS

Prolonging the duration of dual antiplatelet therapy in patients undergoing PCI with DES implantation reduces the risk of stent thrombosis and myocardial infarction, but does result in an increased risk of major bleeding and death.

摘要

目的

探讨药物洗脱支架(DES)植入后经皮冠状动脉介入治疗(PCI)患者延长双联抗血小板治疗(DAPT)疗程的获益与风险。

方法与结果

检索电子科学数据库,查找研究延长与对照DAPT疗程对接受DES植入PCI患者临床影响的随机试验。主要结局为支架血栓形成(ST)、大出血和死亡的发生率。次要结局为心源性死亡、心肌梗死(MI)和脑血管事件(CVE)的发生率。主要分析通过纳入治疗组实际治疗不同时发生的事件来评估主要结局。在单独分析中,纳入试验中最长随访期发生的事件用于风险估计。比值比(95%置信区间)作为汇总统计量。荟萃分析纳入了10项试验,共32194名参与者。延长DAPT组与对照DAPT组的DAPT疗程中位数分别为15(12 - 24)个月和6(6 - 12)个月。中位随访19.5个月后,延长DAPT与对照DAPT相比,降低了ST风险[0.50(0.29 - 0.85),P = 0.01]和MI风险[0.55(0.45 - 0.67),P < 0.001],但代价是大出血风险[1.67(1.31 - 2.13),P < 0.001]和死亡风险[1.25(1.02 - 1.53),P = 0.03]增加。延长DAPT与对照DAPT相比,不影响心源性死亡风险[1.08(0.82 - 1.44),P = 0.74]或CVE风险[0.84(0.57 - 1.24),P = 0.39]。

结论

DES植入后接受PCI的患者延长双联抗血小板治疗疗程可降低支架血栓形成和心肌梗死风险,但确实会增加大出血和死亡风险。

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