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. 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.