Paclitaxel-Coated Devices in Patients With Chronic Limb-Threatening Ischemia and Tissue Loss Undergoing Infrainguinal Endovascular Revascularization: Insights From the SWEDEPAD-1 Trial

BACKGROUND: Patients with chronic limb-threatening ischemia and tissue loss (Rutherford 5-6) are at high risk of major amputation. Drug-coated technologies are effective in coronary interventions, but their impact on limb outcomes in advanced ischemia remains uncertain. We evaluated whether drug-coated devices improve limb salvage in this high-risk population. METHODS: This post hoc subgroup analysis used data from SWEDEPAD-1 (Swedish Drug-Elution Trial in Peripheral Arterial Disease), a multicenter registry-based randomized controlled trial of endovascular treatment for infrainguinal arterial disease. Adults with chronic limb-threatening ischemia were randomized 1:1 to treatment with paclitaxel-coated or uncoated endovascular devices. Only patients with tissue loss (Rutherford 5 or 6) were included. The primary end point was time to ipsilateral major amputation. Secondary end points were target vessel reintervention and a composite of major amputation or target vessel reintervention. Outcomes were assessed at 3 months, 1 year, and 5 years using intention-to-treat analyses and adjusted Cox proportional hazards models. RESULTS: Among 1761 patients (median age, 77 years; 60.1% male; 58.4% diabetes), ipsilateral major amputation within 3 months was more frequent in the paclitaxel-coated group than in the uncoated group (10.4% versus 7.5%; adjusted hazard ratio, 1.43 [95% CI, 1.04-1.96]). Amputation rates were similar at 1 year (16.3% versus 14.6%) and remained comparable through 5 years. Target vessel reintervention at 1 year was lower with paclitaxel-coated devices (13.6% versus 18.0%; adjusted hazard ratio, 0.77 [95% CI, 0.61-0.97]), but this difference was attenuated when early limb loss was included in a composite end point. No significant between-group differences were observed at 5 years. CONCLUSIONS: In patients with chronic limb-threatening ischemia and tissue loss, paclitaxel-coated devices did not improve limb salvage and were associated with a higher early risk of major amputation. Although target vessel reintervention was reduced at 1 year, this apparent benefit was not maintained when accounting for the competing risk of limb loss in a composite end point. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02051088.