Efficacy and Safety of Drug-Coated Balloons Alone Versus Combined with Provisional Stenting for Complex Femoropopliteal Artery Lesions.

Abstract

Complex femoropopliteal artery (FPA) lesions often require provisional stenting after suboptimal drug-coated balloon (DCB) angioplasty. This study compared midterm efficacy and safety of DCB alone versus DCB with provisional bare-metal stenting (BMS) in such lesions. In this retrospective cohort study, 326 propensity score-matched patients (163 per group) treated for FPA disease (2018-2022) were analyzed. Primary effectiveness endpoints were 24-month primary patency (PP) and freedom from clinically driven target lesion revascularization (FCD-TLR). Primary safety endpoints included amputation-free survival (AFS) and all-cause mortality. The stented group had longer lesions (21.2 vs. 17.6 cm, P=0.003), lower ankle-brachial index (0.32 vs. 0.48, P<0.001), and more severe calcification (29.8% vs. 20.6%, P=0.009). At 24 months, PP (83.9% vs. 83.5%, log-rank P=0.873) and FCD-TLR (86.3% vs. 85.9%, P=0.853) were comparable. AFS (92.3% vs. 94.1%, P=0.508) and mortality (1.8% vs. 2.4%, P=0.715) also showed no significant differences. Secondary outcomes were similar. In conclusion, DCB with provisional BMS demonstrates comparable midterm efficacy and safety to DCB alone for complex FPA lesions, supporting provisional BMS use when suboptimal results occur.