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Coronary disease & ACSRandomised controlled trial

Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial

LancetPublished

  • Randomised controlled trial
  • open-label
  • non-inferiority
  • 43 sites in China
  • Median follow-up 734 days (IQR 731-739)
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Authors' conclusion

In patients with de novo, non-complex coronary artery disease, irrespective of vessel diameter, a strategy of DCB angioplasty with rescue stenting did not achieve non-inferiority compared with the intended DES implantation in terms of the DoCE at 2 years

Study context

Population
Adults with de novo, non-complex CAD (irrespective of vessel diameter) and an indication for PCI
Participants
2,272 adults
Comparison
Drug-coated balloon (DCB) angioplasty with rescue stenting vs intended drug-eluting stent (DES) deployment
  • DCBn = 1,133
  • DESn = 1,139reference
Primary endpoint
Device-oriented composite endpoint (DoCE:
  • CV death
  • Target vessel MI
  • Clinically
  • Physiologically indicated target lesion revascularisation)
Follow-up
24 months

Primary result

DoCE

Risk difference

3.04%

95% one-sided CI 1.27–4.81

P = 0.0008

Events by treatment group

DCB vs DES
risk difference 3.04% (95% one-sided CI 1.27–4.81); P = 0.0008

Non-inferiority margin 2.68 as printed, not drawn

As reported in the abstract

Further findings

OutcomeDCBDES
Rescue DES after unsatisfactory DCB angioplasty9.4%Not reported in the abstract

Safety

Periprocedural MI

OutcomeDCBDES
Acute vessel closure during interventionNot reported in the abstract0.1%

Acute vessel closure during intervention

No acute vessel closures in DCB

Original publication

Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial. Lancet. Published 2 September 2024. doi:10.1016/s0140-6736(24)01594-0
Read the original article ↗PubMedCite RIS · BibTeX

Summarised from the published abstract; every number is checked against it