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Background: Drug-coated devices are frequently used in coronary and peripheral interventions, but their effect on amputation risk in peripheral artery disease is unclear. We assessed whether drug-coated devices affect the rate of above-ankle amputation in patients with chronic limb-threatening ischaemia undergoing infrainguinal endovascular revascularisation.

Methods: The Swedish Drug-Elution Trial in Peripheral Arterial Disease 1 (SWEDEPAD 1) was a pragmatic, nationwide, multicentre, participant-masked, registry-based, randomised controlled trial at 22 Swedish centres. Adult patients with Rutherford category 4–6 peripheral artery disease scheduled for infrainguinal endovascular treatment were eligible for inclusion. Participants were randomly allocated in a 1:1 ratio after successful guidewire crossing to receive either paclitaxel-coated or uncoated balloons or stents. Randomisation was stratified by centre and performed using a computer-generated sequence with allocation concealment via a secure, registry-embedded web system. The primary efficacy endpoint was ipsilateral major amputation (above the ankle) during follow-up. All analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02051088) and the primary analysis is complete; further analyses are ongoing.

Findings: From Nov 5, 2014, to Sept 29, 2023, 2400 patients were randomly assigned to treatment with paclitaxel-coated devices (n=1206) or with uncoated devices (n=1194). 2355 patients were included in the intention-to-treat analysis (1180 in the paclitaxel-coated group and 1175 in the uncoated group). The median age was 77 years (IQR 71–83), 1317 (55·9%) of 2355 patients were male and 1038 (44·1%) were female, and 1237 (52·6%) patients had preoperative diabetes. Median follow-up was 2·67 years (IQR 1·08–4·78). Most patients (1761 [74·9%] of 2351) had wounds or tissue loss (Rutherford stage 5 or 6). Treated lesions were located in the femoropopliteal vascular segment in 1241 (52·7%) of 2355 patients, in the infrapopliteal segment in 537 (22·8%) patients, and in both segments in 561 (23·8%) patients. Nearly all paclitaxel-coated devices (>99%) used paclitaxel as the coating agent (>99%). There was no significant difference in the rate of ipsilateral major amputation between using paclitaxel-coated or uncoated devices (hazard ratio [HR] 1·05 [95% CI 0·87–1·27]; p=0·61) with maximum of 5 years of follow-up. There was no difference in all-cause mortality (HR 1·04 [95% CI 0·92–1·17]; p=0·54).

Interpretation: In patients with chronic limb-threatening ischaemia undergoing infrainguinal endovascular revascularisation, paclitaxel-coated devices did not reduce major ipsilateral amputations.