Impact of stepwise dual antiplatelet therapy de-escalation in patients with multivessel disease undergoing drug-coated balloon angioplasty: insights from the REC-CAGEFREE II trial

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ABSTRACT BACKGROUND The optimal antiplatelet regimen in patients with acute coronary syndrome (ACS) and multivessel disease undergoing drug-coated balloon (DCB) angioplasty remains unclear. METHODS This was a prespecified subgroup analysis of the REC-CAGEFREE II trial, which was conducted at 41 sites in China and randomized 1948 exclusively DCB-treated participants with ACS to stepwise dual antiplatelet therapy (DAPT) de-escalation or standard DAPT. The primary endpoint was net adverse clinical events (NACE; including all-cause death, stroke, myocardial infarction, revascularization, and BARC type 3 or 5 bleeding) at 12 months. Participants were stratified into multivessel and single-vessel subgroups according to angiographic characteristics. RESULTS Overall, 720/1948 (37.0%) patients had multivessel disease. The multivessel subgroup was associated with a significantly higher risk of NACE compared with the single-vessel subgroup (12.5% versus 6.7%, HR IPTW :1.84, 95%CI:1.35-2.51, P<0.001). No significant interaction was observed between vessel status (multivessel or single-vessel) and treatment allocation with respect to NACE (P interaction =0.542). In the multivessel subgroup, NACE occurred in 44/368 (12.1%) and 45/352 (12.9%) in the stepwise de-escalation and standard DAPT groups (HR IPTW :0.95, 95%CI:0.62-1.75, P=0.818), respectively. In the single-vessel subgroup, NACE occurred in 43/607 (7.1%) and 39/621 (6.3%) in the stepwise de-escalation and standard groups (HR IPTW :1.12, 95%CI:0.72-1.70, P=0.611), respectively. For the prespecified hierarchical secondary endpoint, win ratio analyses yielded more wins for stepwise de-escalation in both subgroups. CONCLUSIONS Among patients with ACS undergoing DCB-only angioplasty, those with multivessel disease were associated with a higher risk of NACE than those with single-vessel disease. Stepwise DAPT de-escalation and standard DAPT exhibited similar risk-benefit profiles in both subgroups. Registration Information ClinicalTrials.gov identifier: NCT04971356 CLINICAL PERSPECTIVE What Is New? This is the first prespecified subgroup analysis that evaluated the efficacy and safety of a stepwise DAPT de-escalation strategy versus standard DAPT among ACS patients with multivessel disease undergoing DCB-only treatment. Our findings suggested that stepwise de-escalation was associated with a numerically similar risk of NACE in both multivessel and single-vessel subgroups compared with standard DAPT. What Are the Clinical Implications? For ACS patients undergoing DCB-only angioplasty, stepwise DAPT de-escalation provides similar ischemic protection while reducing bleeding risk irrespective of coronary disease burden. These findings suggest that the stepwise DAPT de-escalation strategy may be considered for this high ischemic risk population.

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