Background:The optimal duration of antiplatelet therapy (APT) in patients at high bleeding risk with or without oral anticoagulation (OAC) after coronary stenting remains unclear.Methods:In the investigator-initiated, randomize, open-label MASTER DAPT trial (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen), 4579 patients at high bleeding risk were randomized after 1-month dual APT to abbreviated or nonabbreviated APT strategies. Randomization was stratified by concomitant OAC indication. In this subgroup analysis, we report outcomes of populations with or without an OAC indication. In the population with an OAC indication, patients changed immediately to single APT for 5 months (abbreviated regimen) or continued ≥2 months of dual APT and single APT thereafter (nonabbreviated regimen). Patients without an OAC indication changed to single APT for 11 months (abbreviated regimen) or continued ≥5 months of dual APT and single APT thereafter (nonabbreviated regimen). Coprimary outcomes at 335 days after randomization were net adverse clinical outcomes (composite of all-cause death, myocardial infarction, stroke, and Bleeding Academic Research Consortium 3 or 5 bleeding events); major adverse cardiac and cerebral events (all-cause death, myocardial infarction, and stroke); and type 2, 3, or 5 Bleeding Academic Research Consortium bleeding.Results:Net adverse clinical outcomes or major adverse cardiac and cerebral events did not differ with abbreviated versus nonabbreviated APT regimens in patients with OAC indication (n=1666; hazard ratio [HR], 0.83 [95% CI, 0.60–1.15]; and HR, 0.88 [95% CI, 0.60–1.30], respectively) or without OAC indication (n=2913; HR, 1.01 [95% CI, 0.77–1.33]; or HR, 1.06 [95% CI, 0.79–1.44]; P_interaction=0.35 and 0.45, respectively). Bleeding Academic Research Consortium 2, 3, or 5 bleeding did not significantly differ in patients with OAC indication (HR, 0.83 [95% CI, 0.62–1.12]) but was lower with abbreviated APT in patients without OAC indication (HR, 0.55 [95% CI, 0.41–0.74]; P_interaction=0.057). The difference in bleeding in patients without OAC indication was driven mainly by a reduction in Bleeding Academic Research Consortium 2 bleedings (HR, 0.48 [95% CI, 0.33–0.69]; P_interaction=0.021).Conclusions:Rates of net adverse clinical outcomes and major adverse cardiac and cerebral events did not differ with abbreviated APT in patients with high bleeding risk with or without an OAC indication and resulted in lower bleeding rates in patients without an OAC indication.Registration:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03023020.

中文翻译：

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冠状动脉支架置入术后有或没有口服抗凝剂治疗的高出血风险患者的简短抗血小板治疗：一项开放标签、随机、对照试验

背景：冠状动脉支架置入术后有或没有口服抗凝剂 (OAC) 的高出血风险患者抗血小板治疗 (APT) 的最佳持续时间仍不清楚。方法：在研究者发起的随机开放标签 MASTER DAPT 试验中（管理高出血风险患者在生物可吸收聚合物涂层支架植入后采用简化与标准 DAPT 方案），4579 名具有高出血风险的患者在 1 个月的双重 APT 后被随机分配到简化或非简化 APT 策略。通过伴随的 OAC 适应症对随机化进行分层。在这个亚组分析中，我们报告了有或没有 OAC 适应症的人群的结果。在有 OAC 适应症的人群中，患者立即改为单次 APT 治疗 5 个月（简化方案）或继续 ≥2 个月的双重 APT 和单次 APT 之后（非简化方案）。没有 OAC 适应症的患者改为单 APT 11 个月（简化方案）或继续 ≥5 个月的双 APT 和单 APT 之后（非简化方案）。随机分组后 335 天的共同主要结果是净不良临床结果（全因死亡、心肌梗死、中风和出血学术研究联盟 3 或 5 出血事件的复合）；主要不良心脑事件（全因死亡、心肌梗塞和中风）；和 2、3 或 5 型出血学术研究联盟出血。结果：P_交互作用分别 = 0.35 和 0.45）。出血学术研究联盟 2、3 或 5 出血在有 OAC 适应症的患者中没有显着差异（HR，0.83 [95% CI，0.62-1.12]），但在没有 OAC 适应症的患者中，使用缩写 APT 的出血率较低（HR，0.55 [ 95% CI，0.41–0.74]；P_交互作用=0.057）。没有 OAC 适应症的患者的出血差异主要是由于出血学术研究联盟 2 出血的减少（HR，0.48 [95% CI，0.33–0.69]；P_相互作用= 0.021)。结论：在有或没有 OAC 适应症的高出血风险患者中，使用简化的 APT 后，净不良临床结果和主要心脏和脑部不良事件的发生率没有差异，并且导致没有 OAC 适应症的患者的出血率较低。注册：网址：https://www.clinicaltrials.gov；唯一标识符：NCT03023020。