Aortic & peripheral vascular diseaseRandomised controlled trial
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
- Randomised controlled trial
- pragmatic
- nationwide
- multicentre
- participant-masked
- registry-based
- 22 Swedish centres
- Median follow-up 2.67 years (IQR 1.08-4.78)
Authors' conclusion
In patients with chronic limb-threatening ischaemia undergoing infrainguinal endovascular revascularisation, paclitaxel-coated devices did not reduce major ipsilateral amputations.
Study context
- Population
- Adults with chronic limb-threatening ischaemia (Rutherford 4–6 PAD) scheduled for infrainguinal endovascular treatment2,355 in ITT analysis
- Participants
- 2,400 adults
- Comparison
- Paclitaxel-coated vs uncoated balloons or stents
- Paclitaxel-coatedn = 1,206
- Uncoatedn = 1,194reference
- Primary endpoint
- Ipsilateral major amputation (above the ankle)
- Follow-up
- During (maximum 5 years)
Primary result
Ipsilateral major amputation · maximum of 5 years of follow-up
Hazard ratio
1.05
95% CI 0.87–1.27
P = 0.61
Paclitaxel-coated vs Uncoated
HR 1.05 (95% CI 0.87–1.27); P = 0.61
As reported in the abstract
Further findings
All-cause mortality
- No difference in all-cause mortality: HR 1.04 (95% CI 0.92-1.17)
- P = 0.54
- intention-to-treat
Original publication
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. Published 31 August 2025. doi:10.1016/s0140-6736(25)01585-5
Summarised from the published abstract; every number is checked against it