Abstract / Summary
Background and Objectives: Drug-coated balloon (DCB) angioplasty represents an established stentless strategy in percutaneous coronary intervention (PCI), although bailout stenting (BOS) is frequently required in the presence of suboptimal angiographic results. The clinical impact of BOS following DCB remains incompletely defined. Materials and Methods: We performed a systematic review and single-arm meta-analysis of studies reporting clinical outcomes after BOS following DCB angioplasty, with quantitative synthesis restricted to studies reporting BOS-specific clinical outcomes. Pooled event rates for cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and target lesion revascularization (TLR) were estimated using random-effects models. Heterogeneity was assessed using standard heterogeneity statistics. Results: Five studies were included in the systematic review; four studies reporting BOS-specific clinical outcomes contributed to the quantitative synthesis, whereas REC-CAGEFREE I was retained as strategy-level supportive evidence. BOS after DCB angioplasty was associated with low pooled rates of cardiac death (1%), MI (3%), TLR (5%) and TVR (5%), with minimal or moderate heterogeneity across analyses. Overall, pooled outcomes were within the range reported in contemporary drug-eluting stent (DES) trials. Conclusions: BOS following DCB angioplasty was associated with generally low short- to mid-term event rates that were broadly consistent with selected historical DES benchmarks. However, because these comparisons are indirect, comparable safety or efficacy cannot be inferred. BOS may therefore be considered a pragmatic contingency within DCB-based strategies rather than necessarily representing procedural failure.