Coronary disease & ACSCohort study
Clinical Outcomes of Bail-Out Stenting After Drug-Coated Balloon Angioplasty: The International Multicenter BAILOUT Registry
- registry
- international
- multicenter
- consecutive patients
- 17 European centers
Authors' conclusion
In cases of suboptimal angiographic results after DCB angioplasty, bail-out DES implantation is safe, with no increased risk of TLF at 1 year compared with the expected performance goal for an upfront DES-only strategy.
Study context
- Population
- Consecutive patients undergoing bail-out drug-eluting stent (DES) implantation after DCB angioplasty, 2011–2024accounting for 5.5% of all DCB-based percutaneous coronary interventions
- Participants
- 733 patients
- Exposure
- The target lesion failure (TLF) rate was compared with a performance goal of 7.0% for an upfront DES-only strategy, derived from a meta-analysis of contemporary randomized controlled trials.
- Bail-out DES after DCB angioplastyn = 733
- Outcome
- target lesion failure (TLF), defined as the composite of target lesion revascularization, target vessel myocardial infarction, and cardiac death
- Follow-up
- 1 year
Main finding
As reported in the abstract
Bail-out DES after DCB angioplasty
7.0%
cumulative TLF incidence · 95% CI 5.2%–9.3%
- comparable to the performance goal of 7.0%
- P = 0.916
Observational data: associations, not effects.
Further findings
| Outcome | Estimate | P value | |
|---|---|---|---|
| Independent predictors of 1-year TLF — lesion length | hazard ratio 1.02 per mm increase (95% CI 1.01–1.03) | P < 0.001 | |
| Independent predictors of 1-year TLF — paclitaxel-coated balloons vs sirolimus-coated balloons | hazard ratio 1.99 (95% CI 1.01–4.05) | P = 0.048 | |
| 0.20.5125Hazard ratio (log scale) |
Independent predictors of 1-year TLF
| Comparison | hazard ratio (95% CI) | P value | |
|---|---|---|---|
| moderate-to-severe calcification | 2.82 (1.48–5.40) | P = 0.002 | |
| 0.20.5125Hazard ratio (log scale) |
Components of TLF · 1 year
- target lesion revascularization
- 4.1%
- cardiac death
- 1.9%
- target vessel myocardial infarction
- 1.9%
Safety
stent thrombosis
- incidence of stent thrombosis
- 0.6%
Original publication
Clinical Outcomes of Bail-Out Stenting After Drug-Coated Balloon Angioplasty: The International Multicenter BAILOUT Registry. Circ Cardiovasc Interv. Published 30 April 2026. doi:10.1161/circinterventions.125.016461
Summarised from the published abstract; every number is checked against it