Abstract

Background: Stent use in the below-the-knee (BTK) peripheral arteries remains controversial, with scarce data on real world outcomes. Methods: We examined 1572 patients from the XLPAD Registry (NCT01904851) from 2006-2021 that underwent BTK endovascular intervention and stratified them based on stent vs non-stent interventions. The primary outcome was the incidence of major adverse limb events (MALE), which includes death, clinically driven revascularization, amputation, non-fatal myocardial infarction, and stroke. Results: 517 (33%) patients received a stent and 1055 did not. Mean age 68 years, predominantly male (72%). White race was more frequent in stent group (64% vs. 55%, p<0.0001), whereas Hispanic were more prevalent in the non-stent group (19% vs. 9%, p<0.0001). Higher proportion of stented patients were smokers (53% vs. 26%, p<0.0001), fewer were diabetic (63% vs. 72%, p=0.0003) and had chronic kidney disease (17% vs. 28%, p<0.0001). Multivessel treatment was more common in stented patients (1.8 vs 2.8 lesions per case, p<0.0001) and involved SFA (70% vs. 32%, p<0.0001) and popliteal arteries (36% vs. 24%, p<0.0001). Stented patients had more diffuse disease (60% vs. 48%, p<0.0001), in-stent restenosis (10% vs. 4%, p<0.0001) and CTOs (67% vs 46%, p<0.0001). Fluoroscopy time was longer (33 min vs. 30 min, p=0.005) with higher procedural (95% vs. 91%, p=0.008) and technical success rates (98% vs. 94%, p=0.0009). MALE (22 vs. 22%, p=NS) events at 12- months follow-up were similar in both groups. Only surgical revascularization after 12-months was more frequent in stent group (3% vs. 1%, p=0.02). Conclusion: A third of patients undergoing BTK artery intervention received stents in the XLPAD registry with higher rates of procedural and technical success and similar 12-month MALE events.

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