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

초록

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 intergroup 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.

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