Drug-Eluting Stents versus Drug-Coated Balloons Plus Bare-Metal Stents for the Treatment of Femoropopliteal Artery Lesions: 2-Year Outcomes from the TALENT Study.

PURPOSE: To compare the 2-year outcomes of drug-eluting stents (DES) versus drug-coated balloons (DCB) plus bare-metal stents (BMS) in patients with femoropopliteal artery disease.

MATERIALS AND METHODS: Data were analyzed from The Impact of Tibial Runoff on Clinical Outcome of Endovascular Therapy in Femoropopliteal Lesions (TALENT) study, a multicenter, prospective study. Inverse probability of treatment weighting was applied to balance baseline characteristics. The primary outcomes were freedom of all-cause mortality, freedom of major adverse events, clinically driven target lesion revascularization (CD-TLR), and major adverse limb events (MALEs), and the secondary outcomes were the improvement in Rutherford classification and changes in quality of life assessed by the 25-item Vascular Quality of Life questionnaire.

RESULTS: A total of 429 patients were included (81 in DES group; 348 in DCB plus BMS group). During a median (Q1-Q3) follow-up of 20.2 months (11.6-27.1 months), no significant differences were observed between the 2 groups in 2-year freedom of all-cause mortality (91.4% vs 85.1%; P = .096), freedom of major adverse events (79.6% vs 73.9%; P = .330), CD-TLR (9.6% vs 12.6%; P = .737), and MALEs (10.1% vs 12.3%; P = .612). Both treatment modalities significantly improved in VascuQol score and Rutherford classification, with improvement rates of 76.1% and 71.3% at 24 months, respectively. An interaction effect (P = .014 and .005, respectively) was observed for patients with intermittent claudication (R2-R3), suggesting that DES may be associated with lower risks of CD-TLR and MALEs.

CONCLUSIONS: Over the 2-year follow-up, DES and DCB plus BMS demonstrated favorable and comparable overall effectiveness in real-world patients with complex femoropopliteal lesions.