Extended Clopidogrel Monotherapy vs DAPT in Patients With Acute Coronary Syndromes at High Ischemic and Bleeding Risk

作者：Yi Li, Jing Li, Bin Wang, Quanmin Jing, Yujie Zeng, Aijie Hou, Zhifang Wang, Aijun Liu, Jinliang Zhang, Yao‐Jun Zhang, Ping Zhang, Daming Jiang, Bin Liu, Jiamao Fan, Jun Zhang, Li Li, Guohai Su, Ming Yang, Weihong Jiang, Peng Qu, Hesong Zeng, Li Lu, Miaohan Qiu, Leisheng Ru, Shao‐Liang Chen, Yujie Zhou, Shubin Qiao, Gregg W. Stone, Dominick J. Angiolillo, Yaling Han, OPT-BIRISK Investigators, Ping Yang, Gang Wu, Yang Zheng, Liyou Sui, Jianbin Gong, Jie Mi, Hong Chen, Ruiyan Zhang, Xi Su, Xingsheng Zhao, Zhujun Chen, Biao Xu, Hanjun Pei, Na Li, Hongliang Cong, Jinghua Liu, Xiling Shou, Fengde Wang, Da Yin, Xiaofeng Hu, Jian An, Chunyu Zeng, Jincheng Guo, Genshan Ma, Xin‐Fu Zhou, Lefeng Wang, Qin Qin, Qiutang Zeng, Shuangbin Li, Yi Zheng, Zuyi Yuan, Qing Yang, Gang Liu, Xianxian Zhao, Lingge Kong, Jifu Li, Tianchang Li, Ruiping Zhao, Hong Wang, Chunjian Li, Yanbo Jiang, Likun Ma, Ping Hou, Zixin Zhang, Junxia Li, Zhixiong Zhong, Zhimin Du, Zhiyong Wang, Xuezhi Chen, Longzhe Jin, Changqian Wang, Chengxing Shen, Gang Zhao, Xiaohui Liu, Yongjun Li, Chuanyu Gao, Biao Cheng, Jiang Wang, Yuanzhe Jin, Qun Jin, Songjian He, Zhaofen Zheng, Yukun Luo, Yingwu Liu, Taohong Hu, Zhanying Han, WU Wei-heng, Hua Wang, Yi-Tong Ma, Jianhong Tao, Haiming Shi, Fucheng Sun, Yansong Guo, Hongyi Wu, Li Feng, Jianhua Zhu, Shi Xubo, Xiaodong Li · 发表于：JAMA Cardiology · 年份：2024 · DOI：10.1001/jamacardio.2024.0534 · 被引用次数：46 · 研究领域：Antiplatelet Therapy and Cardiovascular Diseases、Atrial Fibrillation Management and Outcomes、Acute Myocardial Infarction Research

Importance: Purinergic receptor P2Y12 (P2Y12) inhibitor monotherapy after a certain period of dual antiplatelet therapy (DAPT) may be an attractive option of maintenance antiplatelet treatment for patients undergoing percutaneous coronary intervention (PCI) who are at both high bleeding and ischemic risk (birisk). Objective: To determine if extended P2Y12 inhibitor monotherapy with clopidogrel is superior to ongoing DAPT with aspirin and clopidogrel after 9 to 12 months of DAPT after PCI in birisk patients with acute coronary syndromes (ACS). Design, Setting, and Participants: This was a multicenter, double-blind, placebo-controlled, randomized clinical trial including birisk patients with ACS who had completed 9 to 12 months of DAPT after drug-eluting stent implantation and were free from adverse events for at least 6 months at 101 China centers between February 2018 and December 2020. Study data were analyzed from April 2023 to May 2023. Interventions: Patients were randomized either to clopidogrel plus placebo or clopidogrel plus aspirin for an additional 9 months. Main Outcomes and Measures: The primary end point was Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding 9 months after randomization. The key secondary end point was major adverse cardiac and cerebral events (MACCE; the composite of all-cause death, myocardial infarction, stroke or clinically driven revascularization). The primary end point was tested for superiority, and the MACCE end point...