Coronary disease & ACSRandomised controlled trial
Sirolimus-Eluting Balloon vs Repeat Drug-Eluting Stent or Balloon Angioplasty for Coronary In-Stent Restenosis
- Randomised controlled trial
- non-inferiority
- Bayesian
- July 2020 to July 2024
Authors' conclusion
The sirolimus DEB was noninferior to a usual care control strategy including 80% repeat DES but not noninferior to DES for single-layer ISR for TLF at 12 months. There was significant interaction on the basis of operator selection of DES vs BA.
Study context
- Population
- Patients with coronary in-stent restenosis after successful lesion predilation390 per protocol
- Participants
- 418 patients
- Comparison
- Sirolimus drug-eluting balloon (DEB) vs usual care
- DEBn = 210
- Controln = 208reference
- Primary endpoint
- TLF (cardiac death, target vessel MI, or clinically driven target lesion revascularization), per protocol
- Follow-up
- 1 year
Primary result
TLF
Difference
1.7%
95% CrI −5.5% to 8.9%
Events by treatment group
DEB vs Control
difference 1.7% (95% CrI −5.5% to 8.9%)
Non-inferiority margin 10 as printed, not drawn
As reported in the abstract
Further findings
| Outcome | DEB | Control | difference (95% CrI) | |
|---|---|---|---|---|
| TLF, DEB vs DES in single-layer ISR (sequential secondary hypothesis test) · CrI; posterior probability for noninferiority 76.07% | 14.2% | Not reported in the abstract | 7.7% (0.6%–14.6%) | |
| TLF by operator-selected control (subgroup) — DEB vs DES · CrI; 15.3% vs 7.1% | 8.1% (1.4%–15.0%) | |||
| −1001020Difference (linear scale) |
| Outcome | difference (95% CrI) |
|---|---|
| TLF by operator-selected control (subgroup) — DEB vs BA · CrI; 23.6% vs 43.6% | 23.7% (−41.4% to −1.5%) |
- Target lesion failure (TLF), DEB vs DES in single-layer in-stent restenosis (ISR) (sequential secondary hypothesis test): DES 6.5%
- TLF by operator-selected control (subgroup): interaction P = 0.0026
Original publication
Sirolimus-Eluting Balloon vs Repeat Drug-Eluting Stent or Balloon Angioplasty for Coronary In-Stent Restenosis. J Am Coll Cardiol. Published 15 April 2026. doi:10.1016/j.jacc.2026.03.021
Summarised from the published abstract; every number is checked against it