The use of paclitaxel-coated devices for infrainguinal endovascular revascularisation does not reduce the rate of major amputation or all-cause mortality in patients with chronic limb-threatening ischaemia (CLTI), according to findings from a large registry-based trial in Sweden.¹ Peripheral artery disease (PAD) is a significant global health issue, and for patients with its most severe form, CLTI, preventing amputation is a primary treatment goal.²

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

After successful guidewire crossing, 2,400 participants were randomly assigned in a 1:1 ratio to receive either paclitaxel-coated devices (balloons or stents) or uncoated devices. The intention-to-treat analysis included 2,355 patients (1,180 in the paclitaxel-coated group and 1,175 in the uncoated group). The primary efficacy endpoint was ipsilateral major amputation, defined as amputation above the ankle, during follow-up.

The patient cohort had a median age of 77 years, and over half (52.6%) had diabetes. The majority of patients (74.9%) presented with wounds or tissue loss (Rutherford stage 5 or 6).

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).

Furthermore, there was no significant difference in the key safety outcome of all-cause mortality between the groups (HR 1.04; 95% CI 0.92–1.17; p=0.54).

These findings from a large, real-world setting suggest that the routine use of more expensive paclitaxel-coated devices does not confer a benefit in terms of limb salvage for patients with CLTI. The study authors concluded that, “In patients with chronic limb-threatening ischaemia undergoing infrainguinal endovascular revascularisation, paclitaxel-coated devices did not reduce major ipsilateral amputations.”¹ Further analyses from the trial 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. Fowkes FG, Aboyans V, Fowkes FJ, et al. Peripheral artery disease: epidemiology and global perspectives. Nat Rev Cardiol. 2017;14:156-170. https://doi.org/10.1038/nrcardio.2016.179.

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