Coronary disease & ACS

Drug-Coated Balloon Angioplasty vs Drug-Eluting Stents in Noncomplex Coronary Bifurcation Lesions: The REC-CAGEFREE I Trial

JACC Cardiovasc IntervPublished Secondary analysis of the REC-CAGEFREE I randomised trial

Authors' conclusion

DCBs were associated with a numerically comparable risk for DoCE compared with DES in noncomplex bifurcations at 2 years.

Study context

Population
Patients with de novo noncomplex coronary lesions, stratified by bifurcation vs nonbifurcation2,257 analysed
Participants
2,272 patients
Comparison
DCB vs drug-eluting stents (DES) in bifurcation and nonbifurcation lesions
Primary endpoint
Device-oriented composite endpoint (DoCE)
Follow-up
24 months
Methodological detailsprespecified subgroup analysis, investigator-initiated, non-inferiority, multicentre (43 sites in China), inverse probability of treatment weighting (IPTW)-adjusted
  • Prespecified subgroup analysis
  • Investigator-initiated
  • Non-inferiority
  • Multicentre (43 sites in China)
  • IPTW-adjusted

Primary result

As reported in the abstract

DoCE by bifurcation status (subgroups)

HRIPTW

2.67

95% CI 1.64–4.33P < 0.001

nonbifurcation: 46 of 735 (6.3%) vs 18 of 749 (2.4%)

HRIPTW

1.03

95% CI 0.53–2.01P = 0.934

bifurcation: 26 of 394 (6.7%) vs 20 of 379 (5.3%)

Further findings

OutcomeHRIPTW (95% CI)P value
DoCE, bifurcation vs nonbifurcation · 24 months46 of 773 (6.0%) vs 64 of 1,484 (4.3%)1.39 (0.87–2.21)P = 0.164

Original publication

Drug-Coated Balloon Angioplasty vs Drug-Eluting Stents in Noncomplex Coronary Bifurcation Lesions: The REC-CAGEFREE I Trial. JACC Cardiovasc Interv. Published 26 March 2026. doi:10.1016/j.jcin.2026.02.009

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