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冠脉血运重建术后P2Y12抑制剂单药治疗的预后并不优于双重抗血小板治疗
2021-06-20 16:36

瑞士提契诺心脏研究所Marco Valgimigli团队研究了冠脉血运重建术后P2Y12抑制剂单药或双重抗血小板治疗的效果。2021年6月16日,《英国医学杂志》发表了这一成果。

为了评估P2Y12抑制剂单药治疗与双重抗血小板治疗(DAPT)的利弊,以及这些关联是否因患者的特征而改变,研究组在Ovid Medline、Embase等数据库中检索从建库到2020年7月16日的文献,筛选出比较口服P2Y12单药治疗和DAPT对无口服抗凝适应症患者冠脉重建后中央判定终点影响的随机对照试验,并进行个体患者水平的荟萃分析。主要结局是全因死亡、心肌梗死和中风的综合结局,风险比的非劣效性边缘为1.15。关键安全终点是出血学术研究联合会(BARC)3型或5型出血。

该荟萃分析共包括6个试验的数据,涉及24096名患者。在按方案分析人群中,P2Y12抑制剂单药治疗组患者中有283例(2.95%)发生主要结局,DAPT组患者中有315例(3.27%),风险比为0.93;在意向治疗人群中,P2Y12抑制剂单药治疗组患者中有303例(2.94%)发生主要结局,DAPT组患者中有338例(3.36%),风险比为0.90。

除性别外,所有亚组的治疗效果都是一致的(交互作用P=0.02),这表明P2Y12抑制剂单药治疗降低了女性原发性缺血终点的风险(风险比为0.64),但未降低男性的风险。P2Y12抑制剂单药治疗的出血风险为0.89%,显著低于DAPT治疗(1.83%),风险比为0.49;除P2Y12抑制剂的类型外,各亚组间结果一致,这表明在DAPT方案中使用较新的P2Y12抑制剂而非氯吡格雷时临床获益更大。

研究结果表明,与DAPT相比,P2Y12抑制剂单药治疗的死亡、心肌梗死或中风风险相差不大,有证据表明这种关联可能因性别而改变,但出血风险显著降低。

附:英文原文

Title: P2Y12 inhibitor monotherapy or dual antiplatelet therapy after coronary revascularisation: individual patient level meta-analysis of randomised controlled trials

Author: Marco Valgimigli, Felice Gragnano, Mattia Branca, Anna Franzone, Usman Baber, Yangsoo Jang, Takeshi Kimura, Joo-Yong Hahn, Qiang Zhao, Stephan Windecker, Charles M Gibson, Byeong-Keuk Kim, Hirotoshi Watanabe, Young Bin Song, Yunpeng Zhu, Pascal Vranckx, Shamir Mehta, Sung-Jin Hong, Kenji Ando, Hyeon-Cheol Gwon, Patrick W Serruys, George D Dangas, Eùgene P McFadden, Dominick J Angiolillo, Dik Heg, Peter Jüni, Roxana Mehran

Issue&Volume: 2021/06/16

Abstract:

Objective To assess the risks and benefits of P2Y12 inhibitor monotherapy compared with dual antiplatelet therapy (DAPT) and whether these associations are modified by patients’ characteristics.

Design Individual patient level meta-analysis of randomised controlled trials.

Data sources Searches were conducted in Ovid Medline, Embase, and three websites (www.tctmd.com, www.escardio.org, www.acc.org/cardiosourceplus) from inception to 16 July 2020. The primary authors provided individual participant data.

Eligibility criteria Randomised controlled trials comparing effects of oral P2Y12 monotherapy and DAPT on centrally adjudicated endpoints after coronary revascularisation in patients without an indication for oral anticoagulation.

Main outcome measures The primary outcome was a composite of all cause death, myocardial infarction, and stroke, tested for non-inferiority against a margin of 1.15 for the hazard ratio. The key safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding.

Results The meta-analysis included data from six trials, including 24096 patients. The primary outcome occurred in 283 (2.95%) patients with P2Y12 inhibitor monotherapy and 315 (3.27%) with DAPT in the per protocol population (hazard ratio 0.93, 95% confidence interval 0.79 to 1.09; P=0.005 for non-inferiority; P=0.38 for superiority; τ2=0.00) and in 303 (2.94%) with P2Y12 inhibitor monotherapy and 338 (3.36%) with DAPT in the intention to treat population (0.90, 0.77 to 1.05; P=0.18 for superiority; τ2=0.00). The treatment effect was consistent across all subgroups, except for sex (P for interaction=0.02), suggesting that P2Y12 inhibitor monotherapy lowers the risk of the primary ischaemic endpoint in women (hazard ratio 0.64, 0.46 to 0.89) but not in men (1.00, 0.83 to 1.19). The risk of bleeding was lower with P2Y12 inhibitor monotherapy than with DAPT (97 (0.89%) v 197 (1.83%); hazard ratio 0.49, 0.39 to 0.63; P<0.001; τ2=0.03), which was consistent across subgroups, except for type of P2Y12 inhibitor (P for interaction=0.02), suggesting greater benefit when a newer P2Y12 inhibitor rather than clopidogrel was part of the DAPT regimen.

Conclusions P2Y12 inhibitor monotherapy was associated with a similar risk of death, myocardial infarction, or stroke, with evidence that this association may be modified by sex, and a lower bleeding risk compared with DAPT.

DOI: 10.1136/bmj.n1332

Source: https://www.bmj.com/content/373/bmj.n1332

BMJ-British Medical Journal:《英国医学杂志》,创刊于1840年。隶属于BMJ出版集团,最新IF:27.604
官方网址:http://www.bmj.com/
投稿链接:https://mc.manuscriptcentral.com/bmj


本期文章:《英国医学杂志》:Online/在线发表

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