Clinical Outcomes of Bail-Out Stenting After Drug-Coated Balloon Angioplasty: The International Multicenter BAILOUT Registry

Background: Drug-coated balloons (DCBs) are increasingly adopted in percutaneous coronary intervention. Bail-out drug-eluting stent (DES) implantation due to suboptimal immediate results after DCB angioplasty is not infrequent, and the clinical outcomes of percutaneous coronary intervention with DCB angioplasty followed by bail-out DES implantation remain unexplored. The aim of this study was to evaluate the safety of bail-out DES implantation following DCB angioplasty in percutaneous coronary intervention. Methods: The BAILOUT registry included consecutive patients undergoing bail-out DES implantation after DCB angioplasty at 17 European centers between 2011 and 2024. The primary end point was target lesion failure (TLF) at 1 year, defined as the composite of target lesion revascularization, target vessel myocardial infarction, and cardiac death. The 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. Results: A total of 733 patients were included, accounting for 5.5% of all DCB-based percutaneous coronary interventions. At 1 year, the cumulative TLF incidence in the overall population was 7.0% (95% CI, 5.2%-9.3%), which was comparable to the performance goal (P=0.916). This was mainly driven by target lesion revascularization (4.1%), while cardiac death and target vessel myocardial infarction occurred both in 1.9% of patients. The incidence of stent thrombosis was 0.6%. Independent predictors of 1-year TLF included lesion length (hazard ratio, 1.02 per mm increase [95% CI, 1.01-1.03]; P<0.001), moderate-to-severe calcification (hazard ratio, 2.82 [95% CI, 1.48-5.40]; P=0.002), and the use of paclitaxel- versus sirolimus-coated balloons (hazard ratio, 1.99 [95% CI, 1.01-4.05]; P=0.048). Conclusions: 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.