Aortic & peripheral vascular diseaseRandomised controlled trial
Long-Term Outcomes of a Drug-Eluting Resorbable Scaffold vs Angioplasty in Infrapopliteal Chronic Limb-Threatening Ischemia
- Randomised controlled trial
- 2:1 randomisation
- 3-year follow-up report
Authors' conclusion
At 3 years, DRS demonstrated sustained advantages over PTA in preserving vessel patency, with lower restenosis and fewer reinterventions while maintaining a comparable safety profile.
Study context
- Population
- Patients with chronic limb-threatening ischemia and infrapopliteal artery disease57% completed 3-year follow-up
- Participants
- 261 patients
- Comparison
- Drug-eluting resorbable scaffold vs angioplasty
- Primary endpoint
- Freedom from above-ankle amputation in the target limb, target vessel occlusion, clinically driven target lesion revascularization (CD-TLR) and binary restenosis of the target lesion
- Follow-up
- 3 years
Primary result
As reported in the abstract
Primary efficacy endpoint (Kaplan-Meier)
P = 0.0025
Further findings
Binary restenosis · 3 years
Limb salvage · 3 years
| Outcome | DRS | PTA | HR (95% CI) | |
|---|---|---|---|---|
| CD-TLR · 3 years · multivariable Cox regression · numerically lower with DRS | 10.2% | 18.4% | 0.46 (0.22–0.97) | |
| 0.20.5125Hazard ratio (log scale) |
Limb salvage · 3 years
- High and comparable
Safety
Primary safety endpoint (freedom from major adverse limb events and perioperative death) · 3 years
Primary safety endpoint (freedom from major adverse limb events and perioperative death) · 3 years
- Comparable
Original publication
Long-Term Outcomes of a Drug-Eluting Resorbable Scaffold vs Angioplasty in Infrapopliteal Chronic Limb-Threatening Ischemia. J Am Coll Cardiol. Published 13 May 2026. doi:10.1016/j.jacc.2026.04.008
Summarised from the published abstract; every number is checked against it