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.