Sirolimus-Coated Balloon in an All-Comer Population of Coronary Artery Disease Patients: The EASTBOURNE Prospective Registry
Authors' conclusion
EASTBOURNE, the largest DCB study in the coronary field, shows the safety and efficacy of a novel SCB in a broad population of coronary artery disease including small vessels and ISR patients at mid-term follow-up.
Study context
- Population
- Real-world all-comer patients with CAD treated with a sirolimus-coated balloon (de novo small-vessel lesions and in-stent restenosis (ISR)), 38 centres in Europe and Asia
- Participants
- 2,123 patients2,440 lesions
- Outcome
- Target lesion revascularization (TLR)
- Follow-up
- 12 months
Methodological detailsmulticentre, investigator-driven, independent clinical events committee
- Multicentre
- Investigator-driven
- Independent clinical events committee
Main finding
As reported in the abstract
TLR (per lesion)
Target lesion revascularization (TLR)
5.9%
Observational data: associations, not effects.
Secondary outcomes
| Outcome | ISR | De novo | Risk ratio (95% CI) | |
|---|---|---|---|---|
| TLR, ISRvs de novo lesions (subgroup) · 12 months | 10.5% | 2.0% | 1.90 (1.13–3.19) | |
| 0.20.5125Risk ratio (log scale) |
Determinant of TLR (multivariate Cox regression)
| OR (95% CI) | ||
|---|---|---|
| ISRMain determinant | 5.5 (3.382–8.881) | |
| 0.10.31310Odds ratio (log scale) |
MACE (death, myocardial infarction (MI), TLR), spontaneous MI, cardiac and all-cause death · 12 months
- Major adverse clinical events
- 9.9%
- Spontaneous MI
- 2.4%
- Cardiac death
- 1.5%
- All-cause death
- 2.5%
Bailout stenting
- Bailout stenting
- 7.7%
Original publication
Sirolimus-Coated Balloon in an All-Comer Population of Coronary Artery Disease Patients: The EASTBOURNE Prospective Registry. JACC Cardiovasc Interv. Published 24 July 2023. doi:10.
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