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][1], [www.escardio.org][2], [www.acc.org/cardiosourceplus][3]) 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 24 096 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. Registration PROSPERO CRD42020176853. [1]: http://www.tctmd.com [2]: http://www.escardio.org [3]: http://www.acc.org/cardiosourceplus

中文翻译：

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冠状动脉血运重建后 P2Y12 抑制剂单药治疗或双重抗血小板治疗：随机对照试验的个体患者水平荟萃分析

目的 评估 P2Y12 抑制剂单药治疗与双重抗血小板治疗 (DAPT) 相比的风险和益处，以及这些关联是否因患者特征而改变。设计随机对照试验的个体患者水平荟萃分析。数据来源 在 Ovid Medline、Embase 和三个网站（[www.tctmd.com][1]、[www.escardio.org][2]、[www.acc.org/cardiosourceplus][3]）中进行了搜索从开始到 2020 年 7 月 16 日。主要作者提供了个人参与者数据。资格标准 比较口服 P2Y12 单药治疗和 DAPT 对无口服抗凝适应症患者冠状动脉血运重建后中央裁定终点的影响的随机对照试验。主要结局指标 主要结局是全因死亡、心肌梗死、和中风，针对风险比的 1.15 边际进行非劣效性测试。关键安全终点是出血学术研究联盟 (BARC) 3 型或 5 型出血。结果 荟萃分析包括来自六项试验的数据，包括 24 096 名患者。主要结局发生在每个方案人群中，283 名（2.95%）P2Y12 抑制剂单药治疗患者和 315 名（3.27%）DAPT 患者（风险比 0.93，95% 置信区间 0.79 至 1.09；P=0.005 非劣效性；P = 0.38 表示优效性；τ2=0.00），303 例（2.94%）使用 P2Y12 抑制剂单药治疗，338 例（3.36%）使用 DAPT 治疗人群（0.90, 0.77 至 1.05；P=0.18 表示优效性；τ2=0.00 ）。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），表明 P2Y12 抑制剂单药治疗可降低女性主要缺血终点的风险（风险比 0.64，0.46 至 0.89），但男性（1.00，0.83 至 1.19）没有。P2Y12 抑制剂单药治疗的出血风险低于 DAPT（97 (0.89%) v 197 (1.83%)；风险比 0.49, 0.39 至 0.63；P<0.001；τ2=0.03），这在各亚组中是一致的，除了对于 P2Y12 抑制剂的类型（相互作用的 P = 0.02），表明当更新的 P2Y12 抑制剂而不是氯吡格雷成为 DAPT 方案的一部分时，获益更大。结论 P2Y12 抑制剂单药治疗与死亡、心肌梗死或中风的风险相似，有证据表明这种关联可能会因性别而改变，并且与 DAPT 相比，出血风险较低。注册 PROSPERO CRD42020176853。[1]：http://www.tctmd.com [2]：http://www.escardio。