Stepwise dual antiplatelet therapy de-escalation versus standard therapy for 12 months in patients with bifurcation lesions undergoing drug-coated balloon angioplasty: Insights from the REC-CAGEFREE II trial.

Authors

Yongmeng Yan, Qiong Wang, Yi Liu, Feng Yang, Yumin Qiu, Yanqing Wu, Jing Zhou, Mingxing Wu, Ping Xie, Lijun Liu, Hua Wang, Yanjin Wei, Zhihui Zhang, Min Fan, Wangwei Yang, Fangjun Mou, Jianzheng Liu, Guotao Fu, Bin Zhu, Zhiwei Jiang, Scot Garg, Yoshinobu Onuma, Duolao Wang, Patrick W Serruys, Xingqiang He, Ling Tao, Chao Gao

Published in

International journal of cardiology. Pages 134961. Oct 04, 2026. Epub Oct 04, 2026.

Abstract

The optimal antiplatelet strategy for patients with acute coronary syndrome (ACS) and bifurcation lesions undergoing drug-coated balloon (DCB) angioplasty remains unclear.
This was a prespecified subgroup analysis of the REC-CAGEFREE II trial, which randomized 1948 ACS patients undergoing DCB-only angioplasty to stepwise dual antiplatelet therapy (DAPT) de-escalation (1-month aspirin plus ticagrelor, 5-month ticagrelor monotherapy, 6-month aspirin monotherapy) or standard DAPT (12-month aspirin plus ticagrelor). Participants were stratified into bifurcation and non-bifurcation subgroups based on whether any target lesion involved a bifurcation, with inverse probability of treatment weighting (IPTW) applied to adjust for imbalances. The primary endpoint was 12-month net adverse clinical events (NACE), defined as a composite of the patient-oriented composite endpoint (PoCE: all-cause death, stroke, myocardial infarction, or revascularization) and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding.
Among 1948 patients, 884 (45.4%) were in the bifurcation subgroup. At 12 months, no significant interaction was observed between bifurcation/non-bifurcation and treatment strategy for NACE (P_interaction = 0.221). In the bifurcation subgroup, NACE occurred in 51/447 (11.5%) patients receiving stepwise DAPT de-escalation and in 41/437 (9.4%) patients receiving standard DAPT (HR_IPTW:1.15, 95%CI:0.75-1.77, P = 0.509). PoCE did not differ significantly between stepwise DAPT de-escalation and standard DAPT groups (11.0% versus 8.0%, HR_IPTW:1.39, 95%CI:0.89-2.16, P = 0.153), whereas stepwise DAPT de-escalation was associated with a lower incidence of BARC type 3 or 5 bleeding (0.5% versus 1.8%, HR_IPTW,0.15, 95%CI:0.03-0.72, P = 0.048).
Stepwise DAPT de-escalation may be a safe and effective strategy for ACS patients with bifurcation lesions undergoing DCB-only angioplasty.

PMID:
42830132
Bibliographic data and abstract were imported from PubMed on 05 Oct 2026.

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