Drug-coated balloons versus drug-eluting stents for superficial femoral artery endovascular therapy.

Abstract

To evaluate whether drug-coated balloon angioplasty is noninferior to drug-eluting stent implantation for real-world femoral artery lesions, defined as superficial femoral artery disease with optional proximal popliteal involvement, using a prespecified propensity score-matching framework. A total of 722 patients from 17 Japanese centers were prospectively enrolled. The primary composite end point at 12 months included restenosis, all-cause death, clinically driven target vessel revascularization, major amputation, or acute limb ischemia. Propensity score matching (1:1, caliper 0.2) was performed using predefined clinical and lesion variables to reduce confounding. Secondary analyses assessed time-to-event outcomes excluding restenosis. After matching, 170 pairs (n = 340) were analyzed. The 12-month follow-up rate was 84.1% with 15.9% loss to follow-up. The primary composite outcome occurred in 32.4% of patients treated with drug-coated balloon angioplasty and 32.9% of those treated with drug-eluting stents, meeting the prespecified 10% noninferiority margin (one-sided P = .02). Sensitivity analyses did not yield fully consistent results, suggesting limited robustness of the noninferiority finding. The secondary composite outcome excluding restenosis showed comparable event-free survival between treatment groups before and after matching. In this multicenter, propensity score-matched analysis, drug-coated balloon angioplasty showed outcomes that were broadly similar to drug-eluting stents for femoral artery endovascular therapy within the prespecified 10% noninferiority margin. However, because sensitivity analyses yielded inconsistent results, a definitive noninferiority conclusion cannot be established. These findings support cautious interpretation and highlight the need for confirmatory randomized trials to define lesion-specific treatment strategies.