Predictors and long-term prognostic significance of bailout stenting during percutaneous coronary interventions with sirolimus-coated balloon: a subanalysis of the EASTBOURNE study.

Abstract

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-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. The aim of this study was to compare the 2-year clinical outcomes of patients requiring BS with those who underwent sirolimus-coated balloon (SCB)-only PCI and to investigate clinical and angiographic predictors of BS. We conducted a post-hoc analysis of the prospective, multicenter, EASTBOURNE study. The overall cohort was stratified into two study groups: patients requiring BS versus those who underwent SCB-only PCI. The primary endpoint was target lesion revascularization (TLR) at 24-month follow-up. Propensity Score Matching (PSM) was utilized to balance clinical and procedural characteristics between the two study groups. The study population included 2084 patients for a total of 2318 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) and were longer (p = 0.012) and with a smaller median reference vessel diameter (p < 0.001). At 24 months, TLR occurred in 133 [6.4%] patients. The two study groups experienced a similar rate of TLR both in the unmatched cohort (6.3% in the SCB-only group vs. 7.3% in the BS group, p=0.683) and after PSM 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, ISR, large and small vessel disease. Revascularization of de-novo lesions and smoking habit were independent positive predictors of BS, while the SCB inflation time was an independent negative predictor of BS by multivariable logistic analysis in the overall population. On the other hand, we did not record any case of vessel thrombosis during follow up. In conclusion, bailout stenting was associated with similar 2-year outcomes compared to SCB-only PCI and thus appear to be a safe bailout strategy for suboptimal angiographic results after DCB angioplasty.