Open this publication in new window or tab >> Department of Radiology, Karolinska University Hospital, Stockholm, Sweden; Department of Clinical Science, Intervention and Technology, Karolinska University, Stockholm, Sweden.
Department of Radiology, Karolinska University Hospital, Stockholm, Sweden.
Department of Thoracic and Vascular Surgery, Vascular Centre, Skåne University Hospital, Malmö, Sweden.
Department of Clinical Science and Education, Karolinska Institutet, Stockholm, Sweden; Department of Surgery, Södersjukhuset, Stockholm, Sweden.
Department of Surgery, Kristianstad Hospital, Kristianstad, Sweden.
Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Cardiothoracic and Vascular Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden; Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala, Sweden; Department of Vascular Surgery, Västmanland Hospital, Västerås, Sweden.
Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
Department of Clinical Sciences, Faculty of Medicine, Lund University, Lund, Sweden; Department of Surgery, Vascular Unit, Helsingborg Hospital, Helsingborg, Sweden.
Department of Radiology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Section of Vascular Surgery, Surgical Clinic, Hallands Hospital, Halmstad, Sweden.
Department of Surgery, Vascular Unit, NU Hospital Group, Trollhättan, Sweden.
Vascular Surgery Unit, Skaraborg Hospital, Skövde, Sweden.
Department of Vascular Surgery, Södra Älvsborg Hospital, Borås, Sweden.
Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala, Sweden; Centre for Clinical Research and Education, Karlstad, Sweden.
Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Department of Surgery, Västervik Hospital, Västervik, Sweden; Department of Clinical Sciences, Unit of Vascular Medicine, Lund University, Malmö, Sweden.
Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala, Sweden.
Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala, Sweden; Centre for Research and Development, Uppsala University, Gävle, Sweden; Department of Surgery, Gävle County Hospital, Gävle, Sweden.
Department of Radiation Sciences, Radiology, Umeå University, Umeå, Sweden.
Department of Vascular Surgery, Karolinska University Hospital, Stockholm, Sweden; Department of Molecular Medicine and Surgery, Vascular Surgery, Karolinska Institutet, Stockholm, Sweden.
Department of Surgery, Sundsvall District Hospital, Sundsvall, Sweden.
Department of Vascular Surgery, Kalmar Hospital, Kalmar, Sweden.
Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
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2025 (English) In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 406, no 10508, p. 1103-1114Article in journal (Refereed) Published
Abstract [en] 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.
Place, publisher, year, edition, pages
Elsevier, 2025
National Category
Cardiology and Cardiovascular Disease Public Health, Global Health and Social Medicine
Identifiers urn:nbn:se:oru:diva-123358 (URN) 10.1016/S0140-6736(25)01585-5 (DOI) 001575231200006 () 40902617 (PubMedID)
Funder Swedish Research CouncilSwedish Heart Lung Foundation
Note Funding Agencies:
Swedish Research Council, Swedish Heart Lung Foundation, and the Swedish state under the agreement between the Swedish Government and county councils.
2025-09-042025-09-042025-10-07 Bibliographically approved