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第二代药物洗脱支架治疗患者双联抗血小板治疗持续时间的Meta分析

Meta-Analysis of the Duration of Dual Antiplatelet Therapy in Patients Treated With Second-Generation Drug-Eluting Stents.

作者信息

D'Ascenzo Fabrizio, Moretti Claudio, Bianco Matteo, Bernardi Alessandro, Taha Salma, Cerrato Enrico, Omedè Pierluigi, Montefusco Antonio, Frangieh Antonio H, Lee Cheol W, Campo Gianluca, Chieffo Alaide, Quadri Giorgio, Pavani Marco, Zoccai Giuseppe B, Gaita Fiorenzo, Park Seung-Jung, Colombo Antonio, Templin Christian, Lüscher Thomas F, Stone Gregg W

机构信息

Division of Cardiology, Città Della Salute e della Scienza Hospital, Turin, Italy.

Division of Cardiology, Città Della Salute e della Scienza Hospital, Turin, Italy.

出版信息

Am J Cardiol. 2016 Jun 1;117(11):1714-23. doi: 10.1016/j.amjcard.2016.03.005. Epub 2016 Mar 19.

Abstract

The purpose of the study was to evaluate the optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention, especially in the era of second-generation drug-eluting stents (DES). The work was conducted from November 2014 to April 2015. All randomized controlled trials comparing short (<12 months) versus long (≥12 months) DAPT in patients treated with second-generation DES were analyzed. Sensitivity analyses were performed for length of DAPT and type of DES. All-cause death was the primary end point, whereas cardiovascular death, myocardial infarction (MI), stent thrombosis (ST), and major bleeding were secondary end points. Results were pooled and compared with random-effect models and meta-regression analysis. Eight randomized controlled trials with 18,810 randomized patients were included. The studies compared 3 versus 12 months of DAPT (2 trials), 6 versus 12 months (3 trials), 6 versus 24 months (1 trial), 12 versus 24 months (1 trial), and 12 versus 30 months (1 trial). Comparing short versus long DAPT, there were no significant differences in all-cause death (odds ratio [OR] 0.87; 95% confidence interval [CI] 0.66 to 1.44), cardiovascular death (OR 0.95; 95% CI 0.65 to 1.37), and ST (OR 1.20; 95% CI 0.79 to 1.83), and no differences were present when considering everolimus-eluting and fast-release zotarolimus-eluting stents separately. Shorter DAPT was inferior to longer DAPT in preventing MI (OR 1.35; 95% CI 1.03 to 1.77). Conversely, major bleeding was reduced by shorter DAPT (OR 0.60; 95% CI 0.42 to 0.96). Baseline features did not influence these results in meta-regression analysis. In conclusion, DAPT for ≤6 months is reasonable for patients treated with everolimus-eluting and fast-release zotarolimus-eluting stents, with the benefit of less major bleeding at the cost of increased MI, with similar survival and ST rates. An individualized patient approach to DAPT duration should take into account the competing risks of bleeding and ischemic complications after present-generation DES.

摘要

本研究的目的是评估经皮冠状动脉介入治疗后双重抗血小板治疗(DAPT)的最佳持续时间,尤其是在第二代药物洗脱支架(DES)时代。该研究于2014年11月至2015年4月进行。分析了所有比较接受第二代DES治疗的患者短期(<12个月)与长期(≥12个月)DAPT的随机对照试验。对DAPT的持续时间和DES的类型进行了敏感性分析。全因死亡是主要终点,而心血管死亡、心肌梗死(MI)、支架血栓形成(ST)和大出血是次要终点。汇总结果并与随机效应模型和Meta回归分析进行比较。纳入了8项随机对照试验,共18,810例随机患者。这些研究比较了3个月与12个月的DAPT(2项试验)、6个月与12个月(3项试验)、6个月与24个月(1项试验)、12个月与24个月(1项试验)以及12个月与30个月(1项试验)。比较短期与长期DAPT,全因死亡(优势比[OR]0.87;95%置信区间[CI]0.66至1.44)、心血管死亡(OR 0.95;95%CI 0.65至1.37)和ST(OR 1.20;95%CI 0.79至1.83)无显著差异,分别考虑依维莫司洗脱支架和速释佐他莫司洗脱支架时也无差异。在预防MI方面,较短的DAPT不如较长的DAPT(OR 1.35;95%CI 1.03至1.77)。相反,较短的DAPT可减少大出血(OR 0.60;95%CI 0.42至0.96)。在Meta回归分析中,基线特征并未影响这些结果。总之,对于接受依维莫司洗脱支架和速释佐他莫司洗脱支架治疗的患者,≤6个月的DAPT是合理的,其益处是大出血较少,但代价是MI增加,生存和ST率相似。针对DAPT持续时间的个体化患者方法应考虑当代DES后出血和缺血性并发症的竞争风险。

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