International journal of cardiology · 2026
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.
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Yan Yongmeng, Wang Qiong, Liu Yi, Yang Feng, Qiu Yumin, Wu Yanqing, Zhou Jing, Wu Mingxing, Xie Ping, Liu Lijun, Wang Hua, Wei Yanjin, Zhang Zhihui, Fan Min, Yang Wangwei, Mou Fangjun, Liu Jianzheng, Fu Guotao, Zhu Bin, Jiang Zhiwei, Garg Scot, Onuma Yoshinobu, Wang Duolao, Serruys Patrick W, He Xingqiang, Tao Ling, Gao Chao
Аннотация
BACKGROUND: The optimal antiplatelet strategy for patients with acute coronary syndrome (ACS) and bifurcation lesions undergoing drug-coated balloon (DCB) angioplasty remains unclear.
METHODS: 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.
RESULTS: 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 (Pinteraction = 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 (HRIPTW: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%, HRIPTW: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%, HRIPTW,0.15, 95%CI:0.03-0.72, P = 0.048).
CONCLUSIONS: Stepwise DAPT de-escalation may be a safe and effective strategy for ACS patients with bifurcation lesions undergoing DCB-only angioplasty.
METHODS: 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.
RESULTS: 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 (Pinteraction = 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 (HRIPTW: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%, HRIPTW: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%, HRIPTW,0.15, 95%CI:0.03-0.72, P = 0.048).
CONCLUSIONS: Stepwise DAPT de-escalation may be a safe and effective strategy for ACS patients with bifurcation lesions undergoing DCB-only angioplasty.