Sirolimus-Eluting Balloon vs Repeat Drug-Eluting Stent or Balloon Angioplasty for Coronary In-Stent Restenosis
Primary result · TLFResult — go to the resultDifference 1.7% 95% CrI −5.5% to 8.9%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
Methodological detailsnon-inferiority, Bayesian, July 2020 to July 2024
- Non-inferiority
- Bayesian
- July 2020 to July 2024
Primary result
TLF
Difference
1.7%
95% CrI −5.5% to 8.9%
Events by treatment group
DEBvs 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 | Difference (95% CrI) | |
|---|---|---|---|
| TLF, DEBvs DES in single-layer ISR (sequential secondary hypothesis test)CrI; posterior probability for noninferiority 76.07% | 14.2% | 7.7% (0.6%–14.6%) | |
| TLF by operator-selected control (subgroup)DEBvs DESCrI; 15.3% vs 7.1% | 8.1% (1.4%–15.0%) | ||
| −1001020Difference (linear scale) |
| Outcome | Difference (95% CrI) |
|---|---|
| TLF by operator-selected control (subgroup)Between DEB and 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.
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