Aortic & peripheral vascular disease
A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial
Primary result · Major amputation or deathResult — go to the resultAdjusted hazard ratio 1.35 95% CI 1.02–1.80Authors' conclusion
In the BASIL-2 trial, a best endovascular treatment first revascularisation strategy was associated with a better amputation-free survival, which was largely driven by fewer deaths in the best endovascular treatment group.
Study context
- Population
- Patients with chronic limb-threatening ischaemia due to atherosclerotic disease requiring an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation
- Participants
- 345 patients
- Comparison
- Vein bypass first vs best endovascular treatment first
- Vein bypassn = 172
- Best endovascular treatmentn = 173reference
- Primary endpoint
- Amputation-free survival (time to first major [above the ankle] amputation or death from any cause)
Methodological detailsopen-label, pragmatic, multicentre, phase 3, 41 vascular surgery units in the UK, Sweden and Denmark, Minimum follow-up 2 years
- Open-label
- Pragmatic
- Multicentre
- Phase 3
- 41 vascular surgery units in the UK, Sweden and Denmark
- Minimum follow-up 2 years
Primary result
Major amputation or death
Adjusted hazard ratio
1.35
95% CI 1.02–1.80
P = 0.037
Events by treatment group
Vein bypassvs Best endovascular treatment
adjusted HR 1.35 (95% CI 1.02–1.80); P = 0.037
As reported in the abstract
Further findings
| Outcome | Vein bypass | Best endovascular treatment | Adjusted HR (95% CI) | |
|---|---|---|---|---|
| Death | 53% | 45% | 1.37 (1.00–1.87) | |
| 0.512Adjusted hazard ratio (log scale) |
| Outcome | Vein bypass | Best endovascular treatment |
|---|---|---|
| Cause of death: CV and respiratoryCV and respiratory deaths not mutually exclusive | ||
| CV deaths | 61 | 49 |
| Respiratory deaths | 25 | 23 |
Original publication
A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial. Lancet. Published 25 April 2023. doi:10.
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