Mid-term clinical outcomes after bailout drug-eluting stenting for suboptimal drug-coated balloon results: Insights from a Milan registry

Background: Drug-coated balloon (DCB) is an alternative to drug-eluting stent (DES) for the treatment of small vessel or in-stent restenosis (ISR) lesions, with bailout stenting reserved for poor results after DCB inflation (residual stenosis or dissection). Data regarding bailout stenting with DES are limited. The aim of this study was to evaluate clinical outcomes after bailout stenting with DES for suboptimal DCB results. Methods: From June 2009 to December 2015, patients who underwent bailout DES implantation for suboptimal results after DCB (residual stenosis > 30% or type C–F dissection) in 2 high-volume centers in Italy were analyzed. The primary endpoint was target lesion failure (TLF) defined as composite of cardiac mortality, target vessel myocardial infarction (MI) and target lesion revascularization (TLR). Results: A total of 103 patients (125 lesions) were analyzed. Mean age was 68.8 ± 9.5 years, 21.4% were diabetic, and 92.2% underwent PCI for stable angina. The left anterior descending artery was most commonly treated (35.2%), followed by right coronary artery (17.6%) and left circumflex artery (17.6%). Lesion complexity was high (type B2/C: 88.8%) and 24.8% were ISR lesions. During the follow-up period (median: 858 days [interquartile range: 467–1665]), the TLF rate was 4.3% at 1 year and 15.4% at 2 years, and mainly driven by TLR (3.3% at 1 year, 14.5% at 2 years, respectively). There were no target vessel MI or definite/probable stent thrombosis events. Conclusions: Bailout stenting with DES for suboptimal DCB results is a feasible and safe strategy at mid-term follow-up.