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.
Yongmeng Yan, Qiong Wang, Yi Liu et al.
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In 30 seconds
This prespecified subgroup analysis of the multicentre randomised REC-CAGEFREE II trial compared stepwise dual antiplatelet therapy (DAPT) de-escalation with 12-month standard DAPT in patients with acute coronary syndrome undergoing drug-coated balloon-only angioplasty. Of 1948 participants, 884 had bifurcation lesions. At 12 months, net adverse clinical events occurred in 11.5% with de-escalation and 9.4% with standard DAPT in the bifurcation subgroup (IPTW HR 1.15, 95% CI 0.75-1.77; P = 0.509). Severe bleeding was less frequent with de-escalation, while the primary composite did not differ significantly.
Key findings
- In the bifurcation subgroup, 12-month NACE was 11.5% with stepwise de-escalation versus 9.4% with standard DAPT (IPTW HR 1.15, 95% CI 0.75-1.77; P = 0.509).
- PoCE was 11.0% versus 8.0%, respectively (IPTW HR 1.39, 95% CI 0.89-2.16; P = 0.153).
- BARC type 3 or 5 bleeding occurred in 0.5% with de-escalation versus 1.8% with standard DAPT (IPTW HR 0.15, 95% CI 0.03-0.72; P = 0.048).
- There was no significant interaction between bifurcation status and treatment strategy for NACE (P interaction = 0.221).
Why it matters
The findings address antiplatelet treatment after DCB-only angioplasty in ACS patients with bifurcation lesions, a setting where the optimal strategy is uncertain. The lower observed rate of severe bleeding with stepwise de-escalation may be clinically relevant, but the subgroup analysis did not establish a significant difference in the primary composite or PoCE.
What to keep in mind
This was a prespecified subgroup analysis, and the bifurcation subgroup comparisons were not statistically significant for NACE or PoCE; estimates therefore remain uncertain.