The use of paclitaxel-coated devices did not reduce the rate of major amputations or death in patients with chronic limb-threatening ischaemia (CLTI) undergoing infrainguinal endovascular revascularisation, according to the results of a large registry-based trial.¹ While drug-coated devices are commonly used in peripheral interventions, their effect on amputation risk has been uncertain.²

The Swedish Drug-Elution Trial in Peripheral Arterial Disease 1 (SWEDEPAD 1) was a pragmatic, nationwide, multicentre, participant-masked, randomised controlled trial conducted at 22 centres in Sweden. The study enrolled adult patients with Rutherford category 4–6 peripheral artery disease scheduled for infrainguinal endovascular treatment.

Following successful guidewire crossing, 2,355 patients were included in the intention-to-treat analysis and randomly assigned in a 1:1 ratio to receive either paclitaxel-coated balloons or stents (n=1,180) or uncoated devices (n=1,175). The primary efficacy endpoint was ipsilateral major amputation (above the ankle) during follow-up. All-cause mortality was a key secondary endpoint.

The median patient age was 77 years, and 52.6% had preoperative diabetes. The majority of patients (74.9%) presented with wounds or tissue loss (Rutherford stage 5 or 6). Lesions were located in the femoropopliteal segment (52.7%), the infrapopliteal segment (22.8%), or both (23.8%).

Over a median follow-up of 2.67 years (maximum 5 years), the trial found no significant difference in the rate of ipsilateral major amputation between the two groups. The hazard ratio (HR) for amputation in the paclitaxel-coated device group versus the uncoated device group was 1.05 (95% CI 0.87–1.27; p=0.61).

Similarly, there was no significant difference in all-cause mortality between the groups (HR 1.04 [95% CI 0.92–1.17]; p=0.54).

The findings from this large, randomised trial suggest that the use of paclitaxel-coated devices does not offer a benefit in terms of limb salvage or survival for patients with CLTI undergoing endovascular revascularisation. The investigators concluded, "In patients with chronic limb-threatening ischaemia undergoing infrainguinal endovascular revascularisation, paclitaxel-coated devices did not reduce major ipsilateral amputations."¹ Further analyses of the trial data are currently ongoing.

This study was funded by the Swedish Research Council, Swedish Heart Lung Foundation, and the Swedish state under the agreement between the Swedish Government and county councils.

References

1. Falkenberg M, James S, Andersson M, et al. 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. Lancet. 2025. https://doi.org/10.1016/S0140-6736(25)01585-5.

2. Conte MS, Bradbury AW, Kolh P, et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. Eur J Vasc Endovasc Surg. 2019;58:S1-109. https://doi.org/10.1016/j.ejvs.2019.05.006.

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