Sirolimus-Coated Balloon Angioplasty for Femoropopliteal Artery Disease Without Tissue Loss: A Secondary Analysis of the SirPAD Trial.

BACKGROUND

Whether sirolimus-coated balloon angioplasty performs better than uncoated balloon angioplasty among patients with exertional symptoms due to femoropopliteal artery disease remains uncertain.

OBJECTIVES

This study sought to describe 1-year outcomes after sirolimus-coated balloon angioplasty among participants in the SirPAD (Sirolimus-Coated Balloon for Peripheral Artery Disease) trial with femoropopliteal artery disease.

METHODS

In this analysis of the multicenter, randomized, blinded-endpoint SirPAD trial, we evaluated outcomes for patients with femoropopliteal target lesions and without tissue loss (Rutherford category ≤4, Fontaine stage ≤III). A secondary subgroup was restricted to patients with a lower disease burden, excluding ischemic rest pain, prior major amputation, or below-the-knee revascularization. We compared the 1-year rate of: 1) target-lesion revascularization (TLR); 2) the composite of TLR and any unplanned amputation; 3) major adverse limb events; and 4) all-cause death.

RESULTS

Among 597 patients, median age was 71 years, 34.7% were women, and median target-lesion length was 150 mm; 53.8% had total occlusion. After 1 year, 50 patients (17.0%) had undergone TLR in the sirolimus-coated balloon group vs 82 (27.1%) among control subjects (absolute risk difference [ARD]: -10.1%; 95% CI: -16.6 to -3.0). Any amputation or any TLR occurred in 17.7% and 27.1% of patients respectively (ARD: -9.4%; 95% CI: -16.0 to -2.7). Major adverse limb events occurred in 4.1% vs 8.9% of patients, respectively (ARD: -4.8%; 95% CI: -9.0 to -0.8). One-year all-cause death was similar (3.7% vs 5.3%).

CONCLUSIONS

Among patients with femoropopliteal artery disease and no tissue loss, sirolimus-coated balloon angioplasty was associated with a lower 1-year rate of TLR compared with uncoated balloon angioplasty. These findings are descriptive rather than confirmatory. (Sirolimus-Coated Balloon for Peripheral Artery Disease; NCT04238546).