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

  1. Yu Zhang
  2. Xingqiang He
  3. Ming Yuan
  4. Fangjun Mou
  5. Jingyu Zhou
  6. Hui Chen
  7. Hua Wang
  8. Wenyi Guo
  9. Yanjin Wei
  10. Zhihui Zhang
  11. Tao Yin
  12. Cheng Zhang
  13. Zhexun Lian
  14. Bin Zhu
  15. Jianzheng Liu
  16. Ruining Zhang
  17. Guotao Fu
  18. Yoshinobu Onuma
  19. Duolao Wang
  20. Patrick W. Serruys
  21. Fu Yi
  22. Chao Gao
  23. Ling Tao
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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.

Article activity feed

  1. Version published to 10.64898/2026.08.31.26361869 on medRxiv