Bypass versus Angioplasty for Severe Ischemia of the Leg-2 - BASIL-2

Contribution To Literature:

The BASIL-2 trial showed that endovascular treatment is associated with improved outcomes (reduction in death or major amputation) compared with vein bypass.


The goal of the trial was to evaluate vein bypass compared with endovascular treatment among patients with chronic limb-threatening ischemia due to infra-popliteal disease.

Study Design

  • Randomized
  • Parallel
  • Open-label
  • Stratified

Patients with chronic limb-threatening ischemia were randomized to vein bypass (n = 172) vs. endovascular treatment (n = 173). In the endovascular treatment group, patients received balloon angioplasty with selective use of bare-metal or drug-eluting stents.

  • Total number of enrollees: 345
  • Duration of follow-up: 24 months
  • Mean patient age: 72 years
  • Percentage female: 19%
  • Percentage with diabetes: 68%

Inclusion criteria:

  • Chronic limb-threatening ischemia due to infra-popliteal disease
  • No peripheral revascularization within the last 12 months
  • Life expectancy of ≥6 months

Exclusion criteria:

  • Ischemic pain or tissue loss not due to atherosclerotic peripheral artery disease

Principal Findings:

The primary outcome, death or major amputation, was 63% in the vein bypass group vs. 53% in the endovascular group (p = 0.037).

Secondary outcomes:

  • Mortality: 53% in the vein bypass group vs. 45% in the endovascular group
  • Major amputation: 20% in the vein bypass group vs. 18% in the endovascular group


Among patients with chronic limb-threatening ischemia due to infra-popliteal disease, endovascular treatment was superior to vein bypass. Endovascular treatment was associated with a reduction in death or major amputation. This trial contrasts with earlier trials (BASIL-1 and BEST-CLI), which found that vein bypass was associated with improved outcomes compared with endovascular treatment.


Bradbury AW, Moakes CA, Popplewell M, et al., on behalf of the BASIL-2 Investigators. A vein bypass first versus a best endovascular treatment first revascularization strategy for patients with chronic limb threatening ischemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularization procedure to restore limb perfusion (BASIL-2): an open-label, randomized, multicenter, phase 3 trial. Lancet 2023;401:1798-809.

Editorial Comment: Kalra A, Kumar A. Endovascular reperfusion strategy for infra-popliteal chronic limb threatening ischemia. Lancet 2023;401:1749-50.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Interventions and Vascular Medicine

Keywords: Amputation, Angioplasty, Balloon, Cardiac Surgical Procedures, Drug-Eluting Stents, Endovascular Procedures, Ischemia, Myocardial Revascularization, Perfusion, Peripheral Arterial Disease, Popliteal Vein, Stents, Vascular Diseases

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