Aortic & peripheral vascular diseaseSecondary analysis
Drug-Eluting Resorbable Scaffold Versus Balloon Angioplasty for Below-the-Knee Peripheral Artery Disease: 2-Year Results From the LIFE-BTK Trial
- Secondary analysis of the LIFE-BTK randomised trial
- multicentre
- subject-blinded
- 2:1 randomisation
- 2-year follow-up
Authors' conclusion
At 2 years, the Esprit BTK DRS demonstrated improved efficacy compared with PTA in maintaining arterial patency, preventing restenosis, and reducing revascularization rates while maintaining a comparable safety profile.
Study context
- Population
- Patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal disease
- Participants
- 261 patients
- Comparison
- DRS vs percutaneous transluminal angioplasty (PTA)
- Primary endpoint
- Freedom from target limb amputation, target vessel occlusion, clinically driven target lesion revascularization or binary restenosis (revised primary efficacy end point)
- Follow-up
- 2 years
Primary result
As reported in the abstract
Primary efficacy end point
P = 0.0004
Further findings
Limb salvage · 2 years
P = 0.34
Binary restenosis · 2 years
P = 0.005
Clinically driven target lesion revascularization · 2 years
P = 0.034
| Outcome | OR | P value |
|---|---|---|
| Scaffold treatment as predictor of efficacy · independent predictor | 0.27 | P = 0.0003 |
Subgroups
- Consistent efficacy across various patient populations
Safety
Primary safety end point: freedom from major adverse limb events and perioperative death · 2 years
P = 0.16
Original publication
Drug-Eluting Resorbable Scaffold Versus Balloon Angioplasty for Below-the-Knee Peripheral Artery Disease: 2-Year Results From the LIFE-BTK Trial. Circulation. Published 10 September 2025. doi:10.1161/circulationaha.125.075080
Summarised from the published abstract; every number is checked against it