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Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in patients with intermittent claudication (SWEDEPAD 2) : a multicentre, participant-masked, registry-based, randomised controlled trial

Nordanstig, Joakim ; James, Stefan ; Andersson, Manne ; Andersson, Mattias ; Delle, Martin ; Engström, Jan ; Fransson, Torbjörn LU orcid ; Gillgren, Peter ; Hilbertson, Anna and Hörer, Tal M , et al. (2025) In The Lancet 406(10508). p.1115-1127
Abstract

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... (More)

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.

FUNDING: The Swedish Research Council, the Swedish Heart Lung Foundation, the Swedish state under the agreement between the Swedish Government and the county councils.

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keywords
Aged, Female, Humans, Male, Angioplasty, Balloon, Coated Materials, Biocompatible, Drug-Eluting Stents, Endovascular Procedures/methods, Intermittent Claudication/surgery, Paclitaxel/administration & dosage, Peripheral Arterial Disease/surgery, Quality of Life, Registries, Sweden, Treatment Outcome
in
The Lancet
volume
406
issue
10508
pages
1115 - 1127
publisher
Elsevier
external identifiers
  • pmid:40902614
  • scopus:105014755351
ISSN
0140-6736
DOI
10.1016/S0140-6736(25)01584-3
language
English
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yes
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Copyright © 2025 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.
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681f9ddf-cb61-499f-baac-4d234d5dee5f
date added to LUP
2025-10-11 17:11:28
date last changed
2025-11-23 07:49:49
@article{681f9ddf-cb61-499f-baac-4d234d5dee5f,
  abstract     = {{<p>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.</p><p>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.</p><p>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).</p><p>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.</p><p>FUNDING: The Swedish Research Council, the Swedish Heart Lung Foundation, the Swedish state under the agreement between the Swedish Government and the county councils.</p>}},
  author       = {{Nordanstig, Joakim and James, Stefan and Andersson, Manne and Andersson, Mattias and Delle, Martin and Engström, Jan and Fransson, Torbjörn and Gillgren, Peter and Hilbertson, Anna and Hörer, Tal M and Jacobsson, Eva and Kragsterman, Björn and Lindbäck, Johan and Lindgren, Hans and Ludwigs, Karin and Mellander, Stefan and Nelzén, Olle and Olin, Robert and Sigvant, Birgitta and Skoog, Per and Starck, Joachim and Tegler, Gustaf and Thorbjørnsen, Knut and Truedson, Maria and Wahlgren, Carl-Magnus and Wallinder, Jonas and Öjersjö, Andreas and Falkenberg, Mårten}},
  issn         = {{0140-6736}},
  keywords     = {{Aged; Female; Humans; Male; Angioplasty, Balloon; Coated Materials, Biocompatible; Drug-Eluting Stents; Endovascular Procedures/methods; Intermittent Claudication/surgery; Paclitaxel/administration & dosage; Peripheral Arterial Disease/surgery; Quality of Life; Registries; Sweden; Treatment Outcome}},
  language     = {{eng}},
  month        = {{09}},
  number       = {{10508}},
  pages        = {{1115--1127}},
  publisher    = {{Elsevier}},
  series       = {{The Lancet}},
  title        = {{Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in patients with intermittent claudication (SWEDEPAD 2) : a multicentre, participant-masked, registry-based, randomised controlled trial}},
  url          = {{http://dx.doi.org/10.1016/S0140-6736(25)01584-3}},
  doi          = {{10.1016/S0140-6736(25)01584-3}},
  volume       = {{406}},
  year         = {{2025}},
}