Coronary disease & ACSCohort study
Sirolimus-Coated Balloon in an All-Comer Population of Coronary Artery Disease Patients
- Prospective registry study
- multicentre
- investigator-driven
- independent clinical events committee
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 patients · 2,440 lesions
- Outcome
- Target lesion revascularization (TLR)
- Follow-up
- 12 months
Main finding
As reported in the abstract
TLR (per lesion)
Target lesion revascularization (TLR)
5.9%
Observational data: associations, not effects.
Secondary outcomes
| Outcome | Values | risk ratio (95% CI) | |
|---|---|---|---|
| TLR, ISR vs de novo lesions (subgroup) · 12 months | ISR 10.5% · De novo 2.0% | 1.90 (1.13–3.19) | |
| 0.20.5125Risk ratio (log scale) |
Determinant of TLR (multivariate Cox regression)
| Comparison | OR (95% CI) | |
|---|---|---|
| ISR · main 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. JACC Cardiovasc Interv. Published 24 July 2023. doi:10.1016/j.jcin.2023.05.005
Summarised from the published abstract; every number is checked against it