3-Year Outcomes of Drug-Eluting Stent vs Drug-Coated Balloon for Femoropopliteal Artery Lesions: Propensity Score-Matched Real-World Study.

BACKGROUND: Long-term comparative data on drug-eluting stents (DES) and drug-coated balloons (DCB) for femoropopliteal artery (FPA) disease remain limited.

OBJECTIVES: The authors sought to compare 3-year outcomes of DES vs DCB without bailout stenting in FPA disease.

METHODS: We retrospectively analyzed 1,406 patients from a multicenter registry who underwent endovascular therapy for FPA using DES (n = 342) or DCB (n = 1,064) after the successful lesion preparation. Successful lesion preparation was defined as <50% residual stenosis and absence of Grade D or higher dissection. The primary outcomes were 3-year primary patency and freedom from clinically driven target lesion revascularization (CD-TLR), analyzed using propensity score matching.

RESULTS: During a median follow-up period (Q1-Q3) of 22.5 months (8.8-37.1 months), 484 cases of patency loss were observed. Propensity score matching resulted in 314 matched pairs: 314 in the DES (Eluvia: 73.9% [232/314], Zilver PTX: 26.1% [82/314]), and 981 in the DCB (IN.PACT: 64.3% [201.8/314], Lutonix: 35.7% [112.2/314]). After matching, the 3-year primary patency was significantly higher in the DES than in the DCB group (65.3% [95% CI: 58.9%-72.4%] vs 59.5% [54.8%-64.5%]; P = 0.042). However, freedom from CD-TLR was similar (73.2% [67.5%-79.4%] vs 72.2% [68.0-%76.7%]; P = 0.27). Lesion length >150 mm and dissection Grade C showed significant interaction effects (P = 0.007 and 0.013, respectively), indicating greater benefit from DES in reducing the restenosis risk.

CONCLUSIONS: Despite successful lesion preparation, DES demonstrated significantly higher primary patency over 3 years. However, this did not translate into a clinical benefit, as freedom from CD-TLR rates remained comparable between groups.