Percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) has been expanding progressively in recent years. Convincing evidence demonstrated the ability of some DCB to promote positive vessel remodeling, with potential clinical benefits at follow-up. When PCI with DCB results in suboptimal angiographic results (residual stenosis >30% or type C to F dissection), bailout stenting (BS) implantation is recommended to mitigate the risk of abrupt vessel occlusion or restenosis. However, clinical studies focusing on BS during PCI with DCB are scarce. This study aimed to compare the 2-year clinical outcomes of patients requiring BS with those who underwent sirolimus-coated balloon (SCB)–only PCI and investigate clinical and angiographic predictors of BS.

We conducted a post hoc analysis of the prospective, multicenter, thE All-comers Sirolimus-coaTed BallOon eURopeaN rEgistry (EASTBOURNE) study. The overall cohort was stratified into 2 study groups: patients requiring BS versus those who underwent SCB-only PCI.

The primary end point was target lesion revascularization (TLR) at the 24-month follow-up. Propensity score matching was used to balance clinical and procedural characteristics between the 2 study groups.

The study population included 2,084 patients for a total of 2,318 treated lesions. Of them, 181 (7.8%) required BS for suboptimal results during PCI with SCB. Coronary lesions requiring BS were more frequently de novo stenoses (p = 0.016), longer (p = 0.012), and had a smaller median reference vessel diameter (p <0.001). At 24 months, TLR occurred in 133 (6.4%) patients. The 2 study groups experienced a similar rate of TLR in the unmatched cohort (6.3% in the SCB-only group vs 7.3% in the BS group, p = 0.683) and after propensity score matching analysis (4.2% in the SCB-only group vs 8.5% in the BS group, p = 0.223). These results were consistent when considering subpopulations with de novo lesions, in-stent restenosis, and large and small vessel disease. Revascularization of de novo lesions and smoking habit were independent positive predictors of BS, whereas the SCB inflation time was an independent negative predictor of BS by multivariable logistic analysis in the overall population. In contrast, we did not record any case of vessel thrombosis during follow-up.

In conclusion, BS was associated with similar 2-year outcomes compared with SCB-only PCI and, thus, appear to be a safe bailout strategy for suboptimal angiographic results after DCB angioplasty.