Coronary disease & ACSRandomised controlled trial
Sirolimus-Eluting Balloon With Provisional Stenting Versus Systematic Drug-Eluting Stent Implantation to Treat De Novo Coronary Lesions: A Randomized, Open-Label, Noninferiority Trial
- Randomised controlled trial
- multicentre
- open-label
- non-inferiority
Authors' conclusion
At 1 year, in the primary intention-to-treat analysis population, a strategy of percutaneous coronary intervention with SEB and provisional DES was noninferior to the systematic use of DES for the primary end point of target vessel failure.
Study context
- Population
- De novo lesions in coronary arteries 2–5 mm in diameter undergoing PCI
- Participants
- 3,323 lesions · 62 sites
- Comparison
- Sirolimus-eluting balloon (SEB) with provisional DES vs systematic DES
- SEBn = 1,661
- Primary endpoint
- Target vessel failure:
- Cardiac death
- Target vessel-related MI
- Clinically driven target vessel revascularization
- Follow-up
- 1 year
Primary result
Target vessel failure · 365 days
Risk difference
0.91%
95% CI −0.55% to 2.38%
1-sided P=0.02
Events by treatment group
SEB vs Systematic DES
risk difference 0.91% (95% CI −0.55% to 2.38%); 1-sided P=0.02
Non-inferiority margin 2.44 as printed, not drawn
As reported in the abstract
Further findings
| Outcome | SEB | Systematic DES | risk difference (95% CI) | |
|---|---|---|---|---|
| Clinically driven target vessel revascularization | 3.3% | 2.1% | 1.22% (0.11%–2.33%) | |
| −10123Difference (linear scale) |
- Bailout stenting (SEB)
- 20.7% · 343 of 1661
Target vessel failure, per-protocol population
- Noninferiority not confirmed; upper boundary of 95% CI
- 2.63
- P
- P = 0.04
- per-protocol n = 3194 (96%)
Safety
Safety events, including lesion thrombosis
- Low and similar in both groups
Original publication
Sirolimus-Eluting Balloon With Provisional Stenting Versus Systematic Drug-Eluting Stent Implantation to Treat De Novo Coronary Lesions: A Randomized, Open-Label, Noninferiority Trial. Circulation. Published 15 June 2026. doi:10.1161/circulationaha.126.079033
Summarised from the published abstract; every number is checked against it