Importance Discontinuing aspirin after short-term dual antiplatelet therapy (DAPT) was evaluated as a bleeding reduction strategy. However, the strategy of ticagrelor monotherapy has not been exclusively evaluated in patients with acute coronary syndromes (ACS). Objective To determine whether switching to ticagrelor monotherapy after 3 months of DAPT reduces net adverse clinical events compared with ticagrelor-based 12-month DAPT in patients with ACS treated with drug-eluting stents. Design, Setting, and Participants A randomized multicenter trial was conducted in 3056 patients with ACS treated with drug-eluting stents between August 2015 and October 2018 at 38 centers in South Korea. Follow-up was completed in October 2019. Interventions Patients were randomized to receive ticagrelor monotherapy (90 mg twice daily) after 3-month DAPT (n = 1527) or ticagrelor-based 12-month DAPT (n = 1529). Main Outcomes and Measures The primary outcome was a 1-year net adverse clinical event, defined as a composite of major bleeding and adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, or target-vessel revascularization). Prespecified secondary outcomes included major bleeding and major adverse cardiac and cerebrovascular events. Results Among 3056 patients who were randomized (mean age, 61 years; 628 women [20%]; 36% ST-elevation myocardial infarction), 2978 patients (97.4%) completed the trial. The primary outcome occurred in 59 patients (3.9%) receiving ticagrelor monotherapy after 3-month DAPT and in 89 patients (5.9%) receiving ticagrelor-based 12-month DAPT (absolute difference, -1.98% [95% CI, -3.50% to -0.45%]; hazard ratio [HR], 0.66 [95% CI, 0.48 to 0.92]; P = .01). Of 10 prespecified secondary outcomes, 8 showed no significant difference. Major bleeding occurred in 1.7% of patients with ticagrelor monotherapy after 3-month DAPT and in 3.0% of patients with ticagrelor-based 12-month DAPT (HR, 0.56 [95% CI, 0.34 to 0.91]; P = .02). The incidence of major adverse cardiac and cerebrovascular events was not significantly different between the ticagrelor monotherapy after 3-month DAPT group (2.3%) vs the ticagrelor-based 12-month DAPT group (3.4%) (HR, 0.69 [95% CI, 0.45 to 1.06]; P = .09). Conclusions and Relevance Among patients with acute coronary syndromes treated with drug-eluting stents, ticagrelor monotherapy after 3 months of dual antiplatelet therapy, compared with ticagrelor-based 12-month dual antiplatelet therapy, resulted in a modest but statistically significant reduction in a composite outcome of major bleeding and cardiovascular events at 1 year. The study population and lower than expected event rates should be considered in interpreting the trial. Trial Registration ClinicalTrials.gov Identifier: NCT02494895.

中文翻译：

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替格瑞洛单药与替格瑞洛联合阿司匹林对急性冠状动脉综合征患者大出血和心血管事件的影响

重要性 在短期双重抗血小板治疗 (DAPT) 后停用阿司匹林被评估为减少出血的策略。然而，替格瑞洛单药治疗策略尚未专门在急性冠脉综合征 (ACS) 患者中进行评估。目的 确定在接受药物洗脱支架治疗的 ACS 患者中，与基于替格瑞洛的 12 个月 DAPT 相比，在 DAPT 3 个月后改用替格瑞洛单药治疗是否能减少净不良临床事件。设计、设置和参与者 2015 年 8 月至 2018 年 10 月期间，在韩国 38 个中心对 3056 名接受药物洗脱支架治疗的 ACS 患者进行了一项随机多中心试验。随访于2019年10月完成。干预 患者随机接受替格瑞洛单药治疗（90 mg，每天两次），3 个月 DAPT（n = 1527）或基于替格瑞洛的 12 个月 DAPT（n = 1529）。主要结果和测量 主要结果是 1 年净不良临床事件，定义为大出血和不良心脑血管事件（死亡、心肌梗死、支架血栓形成、中风或靶血管血运重建）的复合。预先指定的次要结果包括大出血和严重的心脑血管不良事件。结果 在随机分组的 3056 名患者中（平均年龄 61 岁；628 名女性 [20%]；36% 的 ST 段抬高心肌梗死），2978 名患者（97.4%）完成了试验。主要结局发生在 3 个月 DAPT 后接受替格瑞洛单药治疗的 59 名患者 (3.9%) 和 89 名患者 (5. 9%) 接受基于替格瑞洛的 12 个月 DAPT（绝对差异，-1.98% [95% CI，-3.50% 至 -0.45%]；风险比 [HR]，0.66 [95% CI，0.48 至 0.92]；P = .01）。在 10 个预先指定的次要结果中，8 个没有显着差异。3 个月 DAPT 后接受替格瑞洛单药治疗的患者发生大出血的发生率为 1.7%，接受替格瑞洛为基础的 12 个月 DAPT 治疗的患者发生率为 3.0%（HR，0.56 [95% CI，0.34 至 0.91]；P = .02）。3 个月 DAPT 后替格瑞洛单药治疗组 (2.3%) 与基于替格瑞洛 12 个月 DAPT 组 (3.4%) 的主要心脑血管不良事件发生率无显着差异（HR，0.69 [95% CI， 0.45 到 1.06]；P = .09）。结论和相关性 在接受药物洗脱支架治疗的急性冠脉综合征患者中，与基于替格瑞洛的 12 个月双联抗血小板治疗相比，在接受 3 个月双重抗血小板治疗后，替格瑞洛单药治疗导致 1 年大出血和心血管事件的复合结局适度但有统计学意义的降低。在解释试验时应考虑研究人群和低于预期的事件发生率。试验注册 ClinicalTrials.gov 标识符：NCT02494895。