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BACKGROUND: Drug-coated devices are widely used to reduce restenosis after lower limb revascularisation in patients with peripheral artery disease, but their effect on patient-centred outcomes remains unclear. We assessed the effect of paclitaxel-coated devices on clinically important outcomes in patients with intermittent claudication undergoing infrainguinal endovascular revascularisation.

METHODS: The Swedish Drug-Elution Trial in Peripheral Arterial Disease 2 (SWEDEPAD 2) was a pragmatic, nationwide, multicentre, participant-masked, registry-based, randomised controlled trial conducted at 22 Swedish vascular centres. Adults 18 years or older with intermittent claudication (Rutherford categories 1-3) undergoing infrainguinal endovascular treatment and with no acute thromboembolic disease of the lower limb or infrainguinal aneurysmal disease were eligible for inclusion. Participants were randomly assigned in a 1:1 ratio after successful guidewire crossing to receive either paclitaxel-coated devices 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 the between-group difference in quality of life at 1 year, assessed with the six-item Vascular Quality of Life Questionnaire (VascuQoL-6), a peripheral artery disease-specific quality of life instrument. The trial is registered at ClinicalTrials.gov (NCT02051088) and the primary analysis is complete; further analyses are ongoing.

FINDINGS: Between Nov 5, 2014, and Sept 27, 2023, a total of 1155 patients were enrolled and randomly assigned across 22 vascular centres in Sweden, of whom 1136 (98·3%) had follow-up data available for analysis. 577 patients were randomly assigned to paclitaxel-coated devices and 578 to uncoated devices, of whom 565 (97·9%) and 571 (98·7%) were included in the intention-to-treat population, respectively. The median age in the analysed cohort was 73·0 years (IQR 68·0-78·0). Of the 1136 patients, 612 (53·9%) were male and 524 (46·1%) were female; and 382 (33·7%) of 1135 had preoperative diabetes (one participant in the paclitaxel-coated device group was missing data). Most patients (677 [59·6%] of 1135) presented with severe claudication (Rutherford category 3). Femoropopliteal interventions were performed in 1092 patients (96·1%). At 1 year, VascuQoL-6 scores did not differ between groups (mean difference -0·02 [95% CI -0·66 to 0·62]; p=0·96). All-cause mortality did not differ over a median 7·1 years (IQR 3·9-8·2); hazard ratio (HR) 1·18 (95% CI 0·94-1·48); p=0·16, although 5-year mortality incidence was higher in patients randomly assigned to the paclitaxel-coated devices group (4·57 vs 3·28 per 100 person-years; HR 1·47 [95% CI 1·09-1·98]; p=0·010).

INTERPRETATION: In patients with Rutherford stage 1-3 peripheral artery disease undergoing infrainguinal endovascular revascularisation, paclitaxel-coated devices did not improve disease-specific quality of life at 1 year compared with uncoated devices. All-cause mortality was not different over the total follow-up time, but significantly higher over 5 years. These findings do not support routine use of paclitaxel-coated devices in this patient population.