Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic
Mårten Falkenberg1, Stefan James2, Manne Andersson3
1Department of Radiology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Radiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
Insights
Paclitaxel-coated devices did not reduce major amputations in peripheral artery disease patients undergoing endovascular revascularisation. This study found no significant difference in amputation rates between coated and uncoated devices.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Drug-Eluting Technologies
Background:
- Drug-coated devices are common in interventions but their impact on amputation risk in peripheral artery disease (PAD) is not well-defined.
- This study investigates the effect of drug-coated devices on amputation rates in patients with chronic limb-threatening ischemia (CLTI).
Purpose of the Study:
- To assess if paclitaxel-coated devices reduce the rate of above-ankle amputation in patients with CLTI undergoing infrainguinal endovascular revascularisation.
Main Methods:
- A pragmatic, nationwide, randomized controlled trial (SWEDEPAD 1) involving 2400 patients across 22 Swedish centers.
- Patients with Rutherford category 4-6 PAD received either paclitaxel-coated or uncoated balloons/stents after successful guidewire crossing.
- The primary endpoint was ipsilateral major amputation (above the ankle), analyzed in the intention-to-treat population.
Main Results:
- No significant difference in major ipsilateral amputation rates was observed between paclitaxel-coated and uncoated devices (HR 1.05 [95% CI 0.87-1.27]; p=0.61).
- All-cause mortality also showed no significant difference between the groups (HR 1.04 [95% CI 0.92-1.17]; p=0.54).
- The study included 2355 patients with a median follow-up of 2.67 years, with most patients presenting with tissue loss.
Conclusions:
- Paclitaxel-coated devices did not demonstrate a reduction in major ipsilateral amputations for patients with CLTI undergoing infrainguinal endovascular revascularisation.
- The findings suggest that current drug-coated devices may not offer an advantage in preventing amputations in this high-risk patient population.
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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