Aortic & peripheral vascular diseaseRandomised controlled trial
Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in patients with intermittent claudication (SWEDEPAD 2): a multicentre, participant-masked, registry-based, randomised controlled trial
- Randomised controlled trial
- pragmatic
- nationwide
- multicentre
- participant-masked
- registry-based
- 22 Swedish vascular centres
Authors' conclusion
In patients with Rutherford stage 1-3 peripheral artery disease undergoing infrainguinal endovascular revascularisation, paclitaxel-coated devices did not improve disease-specific quality of life at 1 year compared with uncoated devices. All-cause mortality was not different over the total follow-up time, but significantly higher over 5 years.
Study context
- Population
- Adults with intermittent claudication (Rutherford 1–3) undergoing infrainguinal endovascular treatment1,136 analysed
- Participants
- 1,155 adults
- Comparison
- Paclitaxel-coated devices vs uncoated balloons or stents
- Paclitaxel-coated devicesn = 577
- Uncoated devicesn = 578reference
- Primary endpoint
- Quality of life (VascuQoL-6)
- Follow-up
- 1 year
Primary result
As reported in the abstract
VascuQoL-6 quality of life
VascuQoL-6 scores did not differ between groups
mean difference −0.02 (95% CI −0.66 to 0.62); p=0.96
Further findings
per 100 person-years
| Outcome | Paclitaxel-coated devices | Uncoated devices | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| 5-year mortality incidence | 4.57 | 3.28 | 1.47 (1.09–1.98) | P = 0.010 | |
| All-cause mortality · median 7.1 years (IQR 3.9-8.2) | 1.18 (0.94–1.48) | P = 0.16 | |||
| 0.512Hazard ratio (log scale) |
Original publication
Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in patients with intermittent claudication (SWEDEPAD 2): a multicentre, participant-masked, registry-based, randomised controlled trial. Lancet. Published 31 August 2025. doi:10.1016/s0140-6736(25)01584-3
Summarised from the published abstract; every number is checked against it