Aortic & peripheral vascular disease
Paclitaxel-Coated Devices in Patients With Chronic Limb-Threatening Ischemia and Tissue Loss Undergoing Infrainguinal Endovascular Revascularization: Insights From the SWEDEPAD-1 Trial
Primary result · Time to ipsilateral major amputationResult — go to the resultAdjusted hazard ratio 1.43 95% CI 1.04–1.96Authors' conclusion
In patients with chronic limb-threatening ischemia and tissue loss, paclitaxel-coated devices did not improve limb salvage and were associated with a higher early risk of major amputation. Although target vessel reintervention was reduced at 1 year, this apparent benefit was not maintained when accounting for the competing risk of limb loss in a composite end point.
Study context
- Population
- Adults with chronic limb-threatening ischemia and tissue loss (Rutherford 5 or 6) undergoing infrainguinal endovascular treatment in SWEDEPAD-1patients with tissue loss (median age, 77 years, 60.1% male, 58.4% diabetes)
- Participants
- 1,761 adults
- Comparison
- paclitaxel-coated or uncoated endovascular devices
- Primary endpoint
- Time to ipsilateral major amputation
- Follow-up
- 3 months, 1 year, and 5 years
Methodological detailsmulticenter registry-based randomized controlled trial, randomized 1:1, intention-to-treat analyses, adjusted Cox proportional hazards models
- Multicenter registry-based randomized controlled trial
- Randomized 1:1
- Intention-to-treat analyses
- Adjusted Cox proportional hazards models
Primary result
Time to ipsilateral major amputation
Adjusted hazard ratio
1.43
95% CI 1.04–1.96
By group
Paclitaxel-coated group
- Within 3 months
- 10.4%
- 1 year
- 16.3%
Uncoated group
- Within 3 months
- 7.5%
- 1 year
- 14.6%
Within 3 months
Paclitaxel-coated group10.4%
Uncoated group7.5%
1 year
Paclitaxel-coated group16.3%
Uncoated group14.6%
Paclitaxel-coated group vs uncoated group
adjusted hazard ratio 1.43 (95% CI 1.04–1.96)
As reported in the abstract
Secondary outcomes
| Outcome | Paclitaxel-coated group | Uncoated group | Adjusted hazard ratio (95% CI) | |
|---|---|---|---|---|
| Target vessel reintervention · 1 year · lower with paclitaxel-coated devices · secondary end point | 13.6% | 18.0% | 0.77 (0.61–0.97) | |
| 0.512Adjusted hazard ratio (log scale) |
Composite of major amputation or target vessel reintervention
- Difference attenuated when early limb loss was included in a composite end point
- No significant between-group differences at 5 years
- Secondary end point
Original publication
Paclitaxel-Coated Devices in Patients With Chronic Limb-Threatening Ischemia and Tissue Loss Undergoing Infrainguinal Endovascular Revascularization: Insights From the SWEDEPAD-1 Trial. Circ Cardiovasc Interv. Published 24 September 2026. doi:10.
Summarised from the published abstract; every number is checked against it