Coronary disease & ACSSecondary analysis
Drug-Coated Balloon Angioplasty vs Up-Front Stenting for De Novo CAD
- Secondary analysis of the REC-CAGEFREE I randomised trial
- open-label
- non-inferiority
- multicentre
- 43 sites in China
- 3-year extended follow-up
Authors' conclusion
In patients with de novo coronary artery disease, DCB angioplasty with rescue stenting was associated with a higher rate of the DOCE compared with up-front DES implantation regarding the DOCE at 3 years.
Study context
- Population
- Patients with de novo CAD (regardless of target vessel diameter) after successful lesion predilation
- Participants
- 2,272 patients
- Comparison
- DCB angioplasty with rescue stenting vs up-front drug-eluting stents (DES)
- DCBn = 1,133
- DESn = 1,139reference
- Primary endpoint
- DOCE (CV death, target vessel MI, clinically and physiologically indicated target lesion revascularization)
- Follow-up
- 3 years
Primary result
DOCE
Difference
3.21%
95% CI 1.17%–5.26%
P = 0.002
Events by treatment group
DCB vs DES
difference 3.21% (95% CI 1.17%–5.26%); P = 0.002
As reported in the abstract
Further findings
| Outcome | difference (95% CI) | |
|---|---|---|
| DOCE, landmark analyses (difference DCB vs DES) · 0–1, 1–2, 2–3 years · 0 to 1 year | 1.69% (0.32%–3.06%) | |
| DOCE, landmark analyses (difference DCB vs DES) · 0–1, 1–2, 2–3 years · 1 to 2 years | 1.10% (−0.13% to 2.32%) | |
| DOCE, landmark analyses (difference DCB vs DES) · 0–1, 1–2, 2–3 years | 0.58% (−0.51% to 1.66%) | |
| −2024Difference (linear scale) |
| Outcome | DCB | DES | Estimate |
|---|---|---|---|
| Rescue DES after unsatisfactory DCB angioplasty | 9.4% | Not reported in the abstract |
- Device-oriented composite endpoint (DOCE), landmark analyses (difference DCB vs DES): Ptrend = 0.023
Original publication
Drug-Coated Balloon Angioplasty vs Up-Front Stenting for De Novo CAD. J Am Coll Cardiol. Published 27 October 2025. doi:10.1016/j.jacc.2025.10.027
Summarised from the published abstract; every number is checked against it