Importance Abbreviated dual antiplatelet therapy (DAPT) reduces bleeding with no increase in ischemic events in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). Objectives To evaluate the association of sex with the comparative effectiveness of abbreviated vs standard DAPT in patients with HBR. Design, Setting, and Patients This prespecified subgroup comparative effectiveness analysis followed the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated vs Standard DAPT Regimen (MASTER DAPT) trial, a multicenter, randomized, open-label clinical trial conducted at 140 sites in 30 countries and performed from February 28, 2017, to December 5, 2019. A total of 4579 patients with HBR were randomized at 1 month after PCI to abbreviated or standard DAPT. Data were analyzed from July 1 to October 31, 2022. Interventions Abbreviated (immediate DAPT discontinuation, followed by single APT for ≥6 months) or standard (DAPT for ≥2 additional months, followed by single APT for 11 months) treatment groups. Main Outcomes and Measures One-year net adverse clinical events (NACEs) (a composite of death due to any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (MACCEs) (a composite of death due to any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding (MCB). Results Of the 4579 patients included in the analysis, 1408 (30.7%) were women and 3171 (69.3%) were men (mean [SD] age, 76.0 [8.7] years). Ischemic and bleeding events were similar between sexes. Abbreviated DAPT was associated with comparable NACE rates in men (hazard ratio [HR], 0.97 [95% CI, 0.75-1.24]) and women (HR, 0.87 [95% CI, 0.60-1.26]; P = .65 for interaction). There was evidence of heterogeneity of treatment effect by sex for MACCEs, with a trend toward benefit in women (HR, 0.68 [95% CI, 0.44-1.05]) but not in men (HR, 1.17 [95% CI, 0.88-1.55]; P = .04 for interaction). There was no significant interaction for MCB across sex, although the benefit with abbreviated DAPT was relatively greater in men (HR, 0.65 [95% CI, 0.50-0.84]) than in women (HR, 0.77 [95% CI, 0.53-1.12]; P = .46 for interaction). Results remained consistent in patients with acute coronary syndrome and/or complex PCI. Conclusions and Relevance These findings suggest that women with HBR did not experience higher rates of ischemic or bleeding events compared with men and may derive particular benefit from abbreviated compared with standard DAPT owing to these numerically lower rates of events. Trial Registration ClinicalTrials.gov Identifier: NCT03023020.

中文翻译：

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高出血风险患者按性别进行简化或标准双重抗血小板治疗：随机临床试验的预先指定二次分析。

重要性 对于接受经皮冠状动脉介入治疗 (PCI) 的高出血风险 (HBR) 患者，简化双联抗血小板治疗 (DAPT) 可减少出血，且不会增加缺血事件。目的 评估性别与 HBR 患者简化 DAPT 与标准 DAPT 的比较有效性之间的关系。设计、设置和患者 这项预先指定的亚组比较有效性分析遵循简化与标准 DAPT 方案 (MASTER DAPT) 试验对生物可吸收聚合物涂层支架植入后高出血风险患者的管理，这是一项多中心、随机、开放标签临床试验该研究于 2017 年 2 月 28 日至 2019 年 12 月 5 日在 30 个国家的 140 个地点进行。共有 4579 名 HBR 患者在 PCI 后 1 个月被随机分配至简化或标准 DAPT。数据分析时间为 2022 年 7 月 1 日至 10 月 31 日。干预措施：精简治疗组（立即停用 DAPT，随后单次 APT ≥6 个月）或标准治疗组（DAPT 额外≥2 个月，随后单次 APT 11 个月）治疗组。主要结果和措施 一年净不良临床事件 (NACE)（由于任何原因导致的死亡、心肌梗塞、中风或大出血的综合死亡）、主要不良心脏或大脑事件 (MACCE)（因各种原因导致的死亡的综合）任何原因、心肌梗塞或中风），以及严重或临床相关的非严重出血 (MCB)。结果 在分析中纳入的 4579 名患者中，1408 名 (30.7%) 为女性，3171 名 (69.3%) 为男性（平均 [SD] 年龄，76.0 [8.7] 岁）。两性之间的缺血和出血事件相似。简短的 DAPT 与男性（风险比 [HR]，0.97 [95% CI，0.75-1.24]）和女性（HR，0.87 [95% CI，0.60-1.26]）的 NACE 发生率相关；交互作用 P = .65 ）。有证据表明，MACCE 的治疗效果按性别存在异质性，女性有获益趋势（HR，0.68 [95% CI，0.44-1.05]），但男性则不然（HR，1.17 [95% CI，0.88-1.55]） ]；对于相互作用，P = .04）。尽管缩短 DAPT 的益处在男性中相对较大（HR，0.65 [95% CI，0.50-0.84]），但 MCB 在不同性别之间没有显着的相互作用（HR，0.77 [95% CI，0.53-1.12]） ]；交互作用 P = .46）。急性冠脉综合征和/或复杂 PCI 患者的结果保持一致。结论和相关性 这些研究结果表明，与男性相比，患有 HBR 的女性缺血或出血事件的发生率并不高，并且由于事件发生率在数字上较低，因此与标准 DAPT 相比，可能会从简化的 DAPT 中获得特别的益处。试验注册 ClinicalTrials.gov 标识符：NCT03023020。