ImportanceAntiplatelet monotherapy in the chronic maintenance period for patients with high bleeding risk (HBR) and those who have undergone complex percutaneous coronary intervention (PCI) has not yet been explored.ObjectiveTo compare clopidogrel vs aspirin monotherapy in patients with HBR and/or PCI complexity.Design, Setting, and ParticipantsThis post hoc analysis of the multicenter HOST-EXAM Extended study, an open-label trial conducted across 37 sites in South Korea, enrolled patients from 2014 to 2018 with up to 5.9 years of follow-up. The analysis was conducted from February to November 2023. Patients who maintained dual antiplatelet therapy (DAPT) event-free for 6 to 18 months following PCI were included.InterventionsPatients were randomized to receive either clopidogrel or aspirin in a 1:1 ratio. Those with sufficient data to assess HBR or complex PCI were analyzed.Main Outcomes and MeasuresCoprimary end points were thrombotic composite end point (cardiovascular death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and definite/probable stent thrombosis) and any bleeding (Bleeding Academic Research Consortium type 2 to 5).ResultsOf 3974 patients included (mean [SD] age, 63.4 [10.7] years; 2976 male [74.9%]), 866 had HBR (21.8%), and 849 underwent complex PCI (21.4%). Clopidogrel as compared with aspirin was associated with lower rates of thrombotic and bleeding events regardless of HBR and/or PCI complexity. For the thrombotic composite end point, the hazard ratio (HR) was 0.75 (95% CI, 0.53-1.04) among HBR vs 0.62 (95% CI, 0.48-0.80) among patients without HBR (P for interaction = 0.38) and 0.49 (95% CI, 0.32-0.77) among patients with complex PCI vs 0.74 (95% CI, 0.59-0.92) among patients with noncomplex PCI (P for interaction = 0.12). The reduction in bleeding by clopidogrel compared with aspirin was consistent among both patients with HBR (HR, 0.82; 95% CI, 0.56-1.21) and patients without HBR (HR, 0.58; 95% CI, 0.40-0.85; P for interaction = 0.20) and among patients undergoing complex PCI (HR, 0.79; 95% CI, 0.47-1.33) vs noncomplex PCI (HR, 0.68; 95% CI, 0.50-0.93; P for interaction = 0.62).Conclusions and RelevanceIn this study, in patients who experienced PCI and were event-free during 6 to 18 months of DAPT, the beneficial impact of clopidogrel monotherapy over aspirin monotherapy was consistent, regardless of bleeding risk and/or PCI complexity.Trial RegistrationClinicalTrials.gov Identifier: NCT02044250

中文翻译：

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冠状动脉支架置入术后长期阿司匹林与氯吡格雷的出血风险和手术复杂性


重要性 高出血风险 （HBR） 患者和接受复杂经皮冠状动脉介入治疗 （PCI） 的患者在慢性维持期的抗血小板单药治疗尚未得到探索。目的比较氯吡格雷与阿司匹林单药治疗 HBR 和/或 PCI 复杂性患者。设计、设置和参与者这项对多中心 HOST-EXAM 扩展研究的事后分析是一项在韩国 37 个地点进行的开放标签试验，于 2014 年至 2018 年招募了患者，随访时间长达 5.9 年。该分析于 2023 年 2 月至 11 月进行。纳入 PCI 后维持双重抗血小板治疗 （DAPT） 无事件 6 至 18 个月的患者。干预患者以 1：1 的比例随机接受氯吡格雷或阿司匹林。对那些有足够数据来评估 HBR 或复杂 PCI 的人进行了分析。主要结局和测量共同主要终点是血栓形成复合终点 （心血管死亡、非致命性心肌梗死、中风、急性冠脉综合征再入院和确定/可能的支架血栓形成）和任何出血 （出血学术研究联盟 2 至 5 型）。结果在纳入的 3974 例患者中 （平均 [SD] 年龄，63.4 [10.7] 岁;2976 例男性 [74.9%]），866 例 （21.8%） 接受 HBR，849 例接受复杂 PCI （21.4%）。与阿司匹林相比，氯吡格雷与较低的血栓形成和出血事件发生率相关，无论 HBR 和/或 PCI 复杂性如何。对于血栓形成复合终点，HBR 的风险比 （HR） 为 0.75（95% CI，0.53-1.04），无 HBR 患者为 0.62（95% CI，0.48-0.80）（交互作用 P = 0.38），复杂 PCI 患者为 0.49（95% CI，0.32-0.77），复杂 PCI 患者为 0.74（95% CI，0.59-0。92） 在非复杂性 PCI 患者中 （交互作用 P = 0.12）。与阿司匹林相比，氯吡格雷减少出血量在有 HBR 患者 （HR， 0.82;95% CI， 0.56-1.21） 和无 HBR 患者 （HR， 0.58;95% CI， 0.40-0.85;交互作用 P = 0.20）和接受复杂 PCI 的患者 （HR，0.79;95% CI，0.47-1.33） 与非复杂 PCI （HR，0.68;95% CI，0.50-0.93;交互作用的 P = 0.62）。结论和相关性在本研究中，在经历 PCI 并且在 DAPT 的 6 至 18 个月期间无事件的患者中，无论出血风险和/或 PCI 复杂性如何，氯吡格雷单药治疗优于阿司匹林单药治疗的有益影响是一致的。试验注册临床试验。gov 标识符： NCT02044250