Drug-coated balloon versus drug-eluting stent for isolated ostial side-branch bifurcation (Medina 0.0.1) lesions

Abstract

Background: Medina 0.0.1 bifurcation lesions show high target lesion failure (TLF) after drug-eluting stent (DES) percutaneous coronary intervention (PCI), highlighting an unmet need for alternative treatment strategies. Methods and results: We analyzed 101 patients with Medina 0.0.1 lesions treated with DCB-based PCI from the REAL-DCB registry and 95 DES-treated controls from the COBIS III registry. Primary endpoint was 2-year target lesion failure (TLF): cardiac death, target-vessel myocardial infarction, and clinically-driven target-lesion revascularization (TLR). Inverse probability of treatment weighting (IPTW) was applied to account for inter-group imbalance. DCB group, albeit slightly younger, had more complex risk profile compared to DES group. DCB-based PCI enabled one-device strategy in 96.0% of cases, requiring significantly fewer devices and shorter device lengths than DES-only PCI, in which 52.6% of lesions were treated with a two-stent strategy. Two-year TLF was lower with DCB than with DES (2.2% vs. 12.1%), and this difference remained significant after IPTW adjustment (IPTW-HR: 0.10; 95% CI: 0.02–0.46; P = 0.003), mainly due to lower TLR (IPTW-HR: 0.13; 95% CI: 0.03–0.59; P = 0.009). Target-vessel revascularization was also less frequent with DCB (IPTW-HR: 0.10; 95% CI: 0.02–0.48; P = 0.004). No target-lesion thrombosis occurred in DCB group, whereas one stent thrombosis was reported in DES group. Between-group difference was driven predominantly by TLR, whereas hard ischemic events were infrequent in both groups. Conclusions: In Medina 0.0.1 lesions, DCB-based PCI strategy was associated with lower TLF than DES-only PCI while enabling a simplified device-sparing approach. Given the observational design and limited event count, these findings should be considered hypothesis-generating.