RT Journal Article
SR Electronic
T1 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
JF BMJ
JO BMJ
FD British Medical Journal Publishing Group
SP e082945
DO 10.1136/bmj-2024-082945
VO 388
A1 Gao, Chao
A1 Zhu, Bin
A1 Ouyang, Fan
A1 Wen, Shangyu
A1 Xu, Yanmin
A1 Jia, Wenxia
A1 Yang, Ping
A1 He, Yuquan
A1 Zhong, Yiming
A1 Zhou, Yimeng
A1 Guo, Zhifu
A1 Shen, Guidong
A1 Ma, Likun
A1 Xu, Liang
A1 Xue, Yuzeng
A1 Hu, Tao
A1 Wang, Qiong
A1 Liu, Yi
A1 Zhang, Ruining
A1 Liu, Jianzheng
A1 Jiang, Zhiwei
A1 Xia, Jielai
A1 Garg, Scot
A1 van Geuns, Robert-Jan
A1 Capodanno, Davide
A1 Onuma, Yoshinobu
A1 Wang, Duolao
A1 Serruys, Patrick
A1 Tao, Ling
A1 
YR 2025
UL https://www.bmj.com/content/388/bmj-2024-082945.abstract
AB 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-stent restenosis. The mean drug coated balloon diameter was 2.72 mm (standard deviation 0.49). At 12 months, the primary endpoint occurred in 87 (8.9%) participants in the stepwise de-escalation group and 84 (8.6%) in the standard group (difference 0.36%; upper boundary of the one sided 95% CI 2.47%; Pnon-inferiority=0.013). In the stepwise de-escalation versus standard groups, BARC type 3 or 5 bleeding occurred in four versus 16 participants (0.4% v 1.6%, difference −1.19% (95% CI −2.07% to −0.31%), P=0.008), and all cause death, stroke, myocardial infarction, and revascularisation occurred in 84 versus 74 participants (8.6% v 7.6%, difference 1.05% (95% CI −1.37% to 3.47%), P=0.396). Treated as having hierarchical clinical importance by the win ratio method, more wins were noted with the stepwise de-escalation group (14.4% wins) compared with the standard group (10.1% wins) for the predefined hierarchical composite endpoint of all cause death, stroke, myocardial infarction, BARC type 3 bleeding, revascularisation, and BARC type 2 bleeding (win ratio 1.43 (95% CI 1.12 to 1.83), P=0.004). Results from the per-protocol and the intention-to-treat analysis were similar.Conclusions Among participants with acute coronary syndrome who could be treated by drug coated balloons exclusively, a stepwise DAPT de-escalation was non-inferior to 12 month DAPT for net adverse clinical events.Trial registration Clinicaltrials.gov NCT04971356The REC-CAGEFREE II trial is planning to continue follow-up until 2028. Patient level data collected for this study will not be made publicly available but will be available for data sharing on request for collaboration on specific projects. Any relevant inquiries should be sent to the corresponding author Ling Tao (lingtaofmmu{at}qq.com) or to the first author Chao Gao (woshigaochao{at}gmail.com).