Fredrik Sellgren, Mårten Falkenberg, Manne Andersson, Mattias Andersson, Tom Le Corvec, Martin Delle, Jan Engström, Torbjörn Fransson, Anna Hilbertson, Tal M Hörer, Eva Jacobsson, Stefan James, Björn Kragsterman, Johan Lindbäck, Hans Lindgren, Stefan Mellander, Robert Olin, Birgitta Sigvant, Per Skoog, Christian Smedberg, Joachim Starck, Gustaf Tegler, Knut Thorbjørnsen, Maria Truedson, Per Törnqvist, Carl-Magnus Wahlgren, Jonas Wallinder, Andreas Öjersjö, Joakim Nordanstig
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.
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.