Aortic & peripheral vascular diseaseSecondary analysis
Paclitaxel-Coated Devices in Patients With Chronic Limb-Threatening Ischemia and Tissue Loss Undergoing Infrainguinal Endovascular Revascularization: Insights From the SWEDEPAD-1 Trial
- post hoc subgroup analysis
- multicenter registry-based randomized controlled trial
- randomized 1:1
- intention-to-treat analyses
- adjusted Cox proportional hazards models
Authors' 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
Primary result
As reported in the abstract
Adjusted hazard ratio
1.43
95% CI 1.04–1.96
By group
paclitaxel-coated group
10.4%
within 3 months · 1 year 16.3%
uncoated group
7.5%
within 3 months · 1 year 14.6%
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
Summarised from the published abstract; every number is checked against it