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经皮冠状动脉介入治疗(PCI)使用药物洗脱支架后抗血小板治疗方案的安全性和有效性:一项随机对照试验的网络荟萃分析。

Safety and efficacy of antiplatelet regimens after percutaneous coronary intervention using drug eluting stents: A network meta-analysis of randomized controlled trials.

机构信息

Division of Cardiology, Newark Beth Israel Medical Center, NJ, USA; Cardiovascular Institute, Rutgers Robert Wood Johnson Medical School, NJ, USA.

Department of Medicine, Sinai Hospital, Baltimore, MD, USA.

出版信息

Prog Cardiovasc Dis. 2020 May-Jun;63(3):243-248. doi: 10.1016/j.pcad.2020.03.018. Epub 2020 Apr 3.

Abstract

AIMS

We aimed to determine the efficacy and safety of different anti-platelet regimens after percutaneous coronary intervention (PCI) with drug eluting stent (DES) implantation using a network meta-analysis of randomized controlled trials (RCTs).

METHODS

RCTs comparing shorter duration (≤6 months) of dual antiplatelet therapy (S-DAPT) with either aspirin (ASA) or P2Y12 inhibitor monotherapy against longer duration (≥12 months) DAPT (L-DAPT) after PCI were searched in the MEDLINE, EMBASE and COCHRANE databases. End-points of interest were all-cause death, cardiovascular (CV) death, myocardial infarction (MI), stent thrombosis (ST), major bleeding and major or minor bleeding. Network meta-analyses were performed using frequentist approach.

RESULTS

Eighteen RCTs with total of 57,942 patients met the inclusion and exclusion criteria. This included 14 RCTs (N = 28,853) of S-DAPT with ASA monotherapy and 4 RCTs (N = 29,089) with P2Y12 inhibitor monotherapy. Compared with L-DAPT, the odds of MI were higher with S-DAPT with ASA monotherapy [OR 1.23; 95% CI 1.01-1.48], but not with P2Y12 inhibitor monotherapy [0.98; 0.85-1.14]. Both S-DAPT regimens lowered rates of major bleeding when compared with L-DAPT; ASA monotherapy [0.70; 0.49-1.00] and P2Y12 monotherapy [0.67; 0.45-0.98]. There were no differences in risks of all-cause or CV death between either regimen of S-DAPT and L-DAPT. However, in the acute coronary syndrome subgroup, ASA monotherapy was associated with increased risk of ST [1.55; 1.021-2.36] but P2Y12 monotherapy was not [0.93; 0.58-1.48].

CONCLUSION

Amongst patients undergoing DES implantation, S-DAPT with P2Y12 inhibitor monotherapy reduces bleeding without increased risk of MI or ST compared with L-DAPT. Prospective trials are needed to evaluate if S-DAPT with P2Y12 monotherapy is superior to S-DAPT with ASA monotherapy for ischemic protection.

摘要

目的

我们旨在通过对随机对照试验(RCT)的网络荟萃分析,确定经皮冠状动脉介入治疗(PCI)后使用药物洗脱支架(DES)植入物的不同抗血小板方案的疗效和安全性。

方法

在 MEDLINE、EMBASE 和 Cochrane 数据库中搜索比较 PCI 后较短时间(≤6 个月)双联抗血小板治疗(S-DAPT)与阿司匹林(ASA)或 P2Y12 抑制剂单药治疗与较长时间(≥12 个月)DAPT(L-DAPT)的 RCT。主要终点为全因死亡、心血管(CV)死亡、心肌梗死(MI)、支架血栓形成(ST)、大出血和主要或次要出血。使用贝叶斯方法进行网络荟萃分析。

结果

纳入并排除标准共纳入 18 项 RCT,共 57942 例患者。其中包括 14 项 RCT(N=28853)的 S-DAPT 与 ASA 单药治疗和 4 项 RCT(N=29089)的 P2Y12 抑制剂单药治疗。与 L-DAPT 相比,S-DAPT 联合 ASA 单药治疗的 MI 发生率更高[比值比 1.23;95%置信区间 1.01-1.48],但 P2Y12 抑制剂单药治疗则不然[0.98;0.85-1.14]。与 L-DAPT 相比,S-DAPT 方案均降低了大出血的发生率;ASA 单药治疗[0.70;0.49-1.00]和 P2Y12 单药治疗[0.67;0.45-0.98]。与 L-DAPT 相比,S-DAPT 方案治疗的全因或 CV 死亡风险无差异。然而,在急性冠脉综合征亚组中,ASA 单药治疗与 ST 风险增加相关[1.55;1.021-2.36],但 P2Y12 单药治疗则不然[0.93;0.58-1.48]。

结论

在接受 DES 植入的患者中,与 L-DAPT 相比,P2Y12 抑制剂单药治疗的 S-DAPT 可减少出血,而不会增加 MI 或 ST 的风险。需要前瞻性试验来评估 P2Y12 单药治疗的 S-DAPT 是否优于 ASA 单药治疗的 S-DAPT,以获得更好的缺血保护效果。

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