Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial

作者：Chao Gao, Bin Zhu, Fan Ouyang, Shangyu Wen, Yanmin Xu, Wenxia Jia, Ping Yang, Yuquan He, Yiming Zhong, Yimeng Zhou, Zhifu Guo, Guidong Shen, Likun Ma, Liang Xu, Yuzeng Xue, Tao Hu, Qiong Wang, Yi Liu, Ruining Zhang, Jianzheng Liu, Zhiwei Jiang, Jielai Xia, Scot Garg, Robert-Jan van Geuns, Davide Capodanno, Yoshinobu Onuma, Duolao Wang, Patrick W. Serruys, Ling Tao · 发表于：BMJ · 年份：2025 · DOI：10.1136/bmj-2024-082945 · 被引用次数：35 · 研究领域：Acute Myocardial Infarction Research、Antiplatelet Therapy and Cardiovascular Diseases、Coronary Interventions and Diagnostics

Abstract Objectives To investigate whether a less intense antiplatelet regimen could be used for people receiving drug coated balloons. Design Multicentre, randomised, open label, assessor blind, non-inferiority trial (REC-CAGEFREE II). Setting 41 hospitals in China between 27 November 2021 and 21 January 2023. Participants 1948 adults (18-80 years) with acute coronary syndrome who received treatment exclusively with paclitaxel-coated balloons according to the international drug coated balloon consensus. Interventions Participants were randomly assigned (1:1) to either the stepwise dual antiplatelet therapy (DAPT) de-escalation group (n=975) consisting of aspirin plus ticagrelor for one month, followed by five months of ticagrelor monotherapy, and then six months of aspirin monotherapy, or to the standard DAPT group (n=973) consisting of aspirin plus ticagrelor for 12 months. Main outcome measures The primary endpoint was net adverse clinical events (all cause death, stroke, myocardial infarction, revascularisation, and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding) at 12 months in the intention-to-treat population. Non-inferiority was established if the upper limit of the one sided 95% confidence interval (CI) for the absolute risk difference was smaller than 3.2%. Results The mean age of participants was 59.2 years, 74.9% were men, 30.5% had diabetes, and 20.6% were at high bleeding risk. 60.9% of treated lesions were in small vessels, and 17.8% were in-...