Background and Aims In patients with acute coronary syndrome (ACS), dual antiplatelet therapy (DAPT) with aspirin and a potent P2Y12 inhibitor is recommended for 12 months after drug-eluting stent (DES) implantation. Monotherapy with a potent P2Y12 inhibitor after short-term DAPT is an attractive option to better balance the risks of ischaemia and bleeding. Therefore, this study evaluated the efficacy and safety of ticagrelor monotherapy after short-term DAPT, especially in patients with ACS. Methods Electronic databases were searched from inception to 11 November 2023, and for the primary analysis, individual patient data were pooled from the relevant randomized clinical trials comparing ticagrelor monotherapy after short-term (≤3 months) DAPT with ticagrelor-based 12-month DAPT, exclusively in ACS patients undergoing DES implantation. The co-primary endpoints were ischaemic endpoint (composite of all-cause death, myocardial infarction, or stroke) and bleeding endpoint [Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding] at 1 year. Results Individual patient data from two randomized clinical trials including 5906 ACS patients were analysed. At 1 year, the primary ischaemic endpoint did not differ between the ticagrelor monotherapy and ticagrelor-based DAPT groups [1.9% vs. 2.5%; adjusted hazard ratio (HR) 0.79; 95% confidence interval (CI) 0.56–1.13; P = .194]. The incidence of the primary bleeding endpoint was lower in the ticagrelor monotherapy group (2.4% vs. 4.5%; adjusted HR 0.54; 95% CI 0.40–0.72; P < .001). The results were consistent in a secondary aggregate data meta-analysis including the ACS subgroup of additional randomized clinical trials which enrolled patients with ACS as well as chronic coronary syndrome. Conclusions In ACS patients undergoing DES implantation, ticagrelor monotherapy after short-term DAPT was associated with less major bleeding without a concomitant increase in ischaemic events compared with ticagrelor-based 12-month DAPT. Study registration PROSPERO (ID: CRD42023476470).

中文翻译：

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替格瑞洛单药治疗急性冠脉综合征：TICO 和 T-PASS 试验的个体患者数据荟萃分析


背景和目的 对于急性冠脉综合征 (ACS) 患者，建议在药物洗脱支架 (DES) 植入后使用阿司匹林和强效 P2Y12 抑制剂双重抗血小板治疗 (DAPT) 12 个月。短期 DAPT 后使用强效 P2Y12 抑制剂单药治疗是一种有吸引力的选择，可以更好地平衡缺血和出血的风险。因此，本研究评估了短期 DAPT 后替格瑞洛单药治疗的疗效和安全性，特别是对于 ACS 患者。方法 检索从开始到 2023 年 11 月 11 日的电子数据库，并从相关随机临床试验中汇总个体患者数据进行初步分析，比较短期（≤3 个月）DAPT 后替格瑞洛单药治疗与基于替格瑞洛的 12 个月 DAPT ，仅适用于接受 DES 植入的 ACS 患者。共同主要终点是 1 年时的缺血终点（全因死亡、心肌梗死或中风的复合终点）和出血终点 [出血学术研究联盟 (BARC) 3 型或 5 型出血]。结果 对两项随机临床试验（包括 5906 名 ACS 患者）的个体患者数据进行了分析。 1 年时，替格瑞洛单药治疗组和基于替格瑞洛的 DAPT 组之间的主要缺血终点没有差异 [1.9% vs. 2.5%；调整后的风险比（HR）0.79； 95% 置信区间 (CI) 0.56–1.13； P = .194]。替格瑞洛单药治疗组主要出血终点的发生率较低（2.4% vs. 4.5%；调整后 HR 0.54；95% CI 0.40–0.72；P < .001）。结果与二次汇总数据荟萃分析一致，其中包括 ACS 亚组的额外随机临床试验，该试验纳入了 ACS 和慢性冠状动脉综合征患者。 结论 在接受 DES 植入的 ACS 患者中，与基于替格瑞洛的 12 个月 DAPT 相比，短期 DAPT 后的替格瑞洛单药治疗可减少大出血，且不会伴随缺血事件增加。研究注册 PROSPERO（ID：CRD42023476470）。