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
- 1The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Abstract
BACKGROUNDThe optimal antiplatelet regimen in patients with acute coronary syndrome (ACS) and multivessel disease undergoing drug-coated balloon (DCB) angioplasty remains unclear.
METHODSThis 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.
RESULTSOverall, 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%, HRIPTW: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 (Pinteraction=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 (HRIPTW: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 (HRIPTW: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.
CONCLUSIONSAmong 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 InformationClinicalTrials.gov identifier: NCT04971356
CLINICAL PERSPECTIVEO_ST_ABSWhat Is New?C_ST_ABSO_LIThis 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. C_LIO_LIOur 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. C_LI
What Are the Clinical Implications?O_LIFor 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. C_LI
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BibTeX
@misc{gao2026impact,
title = {{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}},
author = {C. Gao and Y. Zhang and X. He and M. Yuan and F. Mou and J. Zhou and H. Chen and H. Wang and W. Guo and Y. Wei and Z. Zhang and T. Yin and C. Zhang and Z. Lian and B. Zhu and J. Liu and R. Zhang and G. Fu and Y. Onuma and D. Wang and P. W. Serruys and F. Yi and L. Tao},
howpublished = {medRxiv},
year = {2026},
month = aug,
doi = {10.64898/2026.08.31.26361869},
url = {https://www.medrxiv.org/content/10.64898/2026.08.31.26361869v1},
note = {CC BY-NC-ND},
}
RIS
TY - UNPB
TI - 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
AU - C. Gao
AU - Y. Zhang
AU - X. He
AU - M. Yuan
AU - F. Mou
AU - J. Zhou
AU - H. Chen
AU - H. Wang
AU - W. Guo
AU - Y. Wei
AU - Z. Zhang
AU - T. Yin
AU - C. Zhang
AU - Z. Lian
AU - B. Zhu
AU - J. Liu
AU - R. Zhang
AU - G. Fu
AU - Y. Onuma
AU - D. Wang
AU - P. W. Serruys
AU - F. Yi
AU - L. Tao
PY - 2026
DA - 2026/08/31
PB - medRxiv
DO - 10.64898/2026.08.31.26361869
UR - https://www.medrxiv.org/content/10.64898/2026.08.31.26361869v1
AB - BACKGROUNDThe optimal antiplatelet regimen in patients with acute coronary syndrome (ACS) and multivessel disease undergoing drug-coated balloon (DCB) angioplasty remains unclear. METHODSThis 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. RESULTSOverall, 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%, HRIPTW: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 (Pinteraction=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 (HRIPTW: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 (HRIPTW: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. CONCLUSIONSAmong 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 InformationClinicalTrials.gov identifier: NCT04971356 CLINICAL PERSPECTIVEO_ST_ABSWhat Is New?C_ST_ABSO_LIThis 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. C_LIO_LIOur 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. C_LI What Are the Clinical Implications?O_LIFor 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. C_LI
ER -