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Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic limb-threatening ischaemia (SWEDEPAD 1) : a multicentre, participant-masked, registry-based, randomised controlled trial

Falkenberg, Mårten ; 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.1103-1114
Abstract

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... (More)

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.

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

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keywords
Aged, Aged, 80 and over, Female, Humans, Male, Amputation, Surgical/statistics & numerical data, Angioplasty, Balloon, Chronic Disease, Chronic Limb-Threatening Ischemia/surgery, Coated Materials, Biocompatible, Drug-Eluting Stents, Endovascular Procedures/methods, Ischemia/surgery, Paclitaxel/administration & dosage, Peripheral Arterial Disease/surgery, Registries, Sweden, Treatment Outcome
in
The Lancet
volume
406
issue
10508
pages
1103 - 1114
publisher
Elsevier
external identifiers
  • pmid:40902617
  • scopus:105015515915
ISSN
0140-6736
DOI
10.1016/S0140-6736(25)01585-5
language
English
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yes
additional info
Copyright © 2025 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.
id
931b1a31-e9f8-4840-9f65-5066d7f5fb3a
date added to LUP
2025-10-11 17:14:18
date last changed
2025-10-28 09:49:11
@article{931b1a31-e9f8-4840-9f65-5066d7f5fb3a,
  abstract     = {{<p>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.</p><p>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.</p><p>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 (&gt;99%) used paclitaxel as the coating agent (&gt;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).</p><p>INTERPRETATION: In patients with chronic limb-threatening ischaemia undergoing infrainguinal endovascular revascularisation, paclitaxel-coated devices did not reduce major ipsilateral amputations.</p><p>FUNDING: Swedish Research Council, Swedish Heart Lung Foundation, and the Swedish state under the agreement between the Swedish Government and county councils.</p>}},
  author       = {{Falkenberg, Mårten 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 Nordanstig, Joakim}},
  issn         = {{0140-6736}},
  keywords     = {{Aged; Aged, 80 and over; Female; Humans; Male; Amputation, Surgical/statistics & numerical data; Angioplasty, Balloon; Chronic Disease; Chronic Limb-Threatening Ischemia/surgery; Coated Materials, Biocompatible; Drug-Eluting Stents; Endovascular Procedures/methods; Ischemia/surgery; Paclitaxel/administration & dosage; Peripheral Arterial Disease/surgery; Registries; Sweden; Treatment Outcome}},
  language     = {{eng}},
  month        = {{09}},
  number       = {{10508}},
  pages        = {{1103--1114}},
  publisher    = {{Elsevier}},
  series       = {{The Lancet}},
  title        = {{Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic limb-threatening ischaemia (SWEDEPAD 1) : a multicentre, participant-masked, registry-based, randomised controlled trial}},
  url          = {{http://dx.doi.org/10.1016/S0140-6736(25)01585-5}},
  doi          = {{10.1016/S0140-6736(25)01585-5}},
  volume       = {{406}},
  year         = {{2025}},
}