Aortic & peripheral vascular diseaseRandomised controlled trial
Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease
- Randomised controlled trial
- multicentre
- 2:1 randomisation
Authors' conclusion
Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point.
Study context
- Population
- Patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease
- Participants
- 261 patients
- Comparison
- Everolimus-eluting resorbable scaffold vs angioplasty
- Primary endpoint
- Primary efficacy: freedom from amputation above the ankle of the target limb, target vessel occlusion, clinically driven target lesion revascularization and binary target lesion restenosis
- Follow-up
- 1 year
Primary result
Freedom from primary efficacy end point events
Absolute difference
30 percentage points
95% CI 15–46
P < 0.001 for superiority
Events by treatment group
Scaffold vs Angioplasty
absolute difference 30 percentage points (95% CI 15–46); P for superiority < 0.001
As reported in the abstract
Safety
| Outcome | Scaffold | Angioplasty | absolute difference (percentage points) (95% CI) | P value | |
|---|---|---|---|---|---|
| Primary safety end point: freedom from major adverse limb events at 6 months and from perioperative death · one-sided | −3 (−6 to 0) | P for non-inferiority < 0.001 | |||
| Patients analysed | 170 | 90 | |||
| −10−505Difference, percentage points (linear scale) |
Serious adverse events related to the index procedure
- Primary safety end point: freedom from major adverse limb events at 6 months and from perioperative death: non-inferiority met (one-sided P<0.001)
Original publication
Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease. N Engl J Med. Published 25 October 2023. doi:10.1056/nejmoa2305637
Summarised from the published abstract; every number is checked against it