- Question
- In patients with chronic limb-threatening ischaemia needing an infra-popliteal revascularisation, is starting with vein bypass or with best endovascular treatment better for avoiding major amputation and death?
- Design
- Pragmatic, open-label, multicentre, phase 3 trial with 1:1 randomisation, conducted at 41 vascular surgery units in the UK (39), Sweden (1) and Denmark (1). A total of 345 patients were randomised and followed for a minimum of 2 years.
- Population
- Patients with atherosclerotic chronic limb-threatening ischaemia (rest pain, tissue loss, or both) requiring an infra-popliteal revascularisation with or without an additional more proximal infra-inguinal procedure. Patients whose pain or tissue loss was not primarily due to atherosclerotic peripheral artery disease were excluded.
- Intervention
- Vein bypass as the first revascularisation procedure, mostly using the great saphenous vein and originating from the common or superficial femoral artery.
- Control
- Best endovascular treatment as the first procedure, mostly plain balloon angioplasty with selective use of plain or drug-eluting stents.
- Primary outcome
- Amputation-free survival, defined as time to first major (above-the-ankle) amputation or death from any cause, in the intention-to-treat population.
- Results
- Major amputation or death occurred in 108 of 172 patients (63%) in the bypass group and 92 of 173 (53%) in the endovascular group (adjusted HR 1.35; 95% CI 1.02-1.80; P=0.037). Death occurred in 91 patients (53%) with bypass and 77 (45%) with endovascular treatment (adjusted HR 1.37; 95% CI 1.00-1.87).
- Safety
- The most common causes of morbidity and death in both groups, including within 30 days of first revascularisation, were cardiovascular (61 deaths with bypass and 49 with endovascular) and respiratory (25 and 23 deaths, respectively).
- Conclusion
- A best-endovascular-treatment-first strategy was associated with better amputation-free survival, largely driven by fewer deaths in that group.
- Why it matters
- It supported considering an endovascular-first strategy in more patients with chronic limb-threatening ischaemia and infra-popliteal disease, without excluding bypass in selected cases.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026