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

Jun 02, 2023
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
UK National Institute of Health Research Health Technology Programme
Date Published:
04/25/2023
Date Updated:
06/02/2023
Original Posted Date:
05/09/2023
References

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.

Description:

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

Interpretation:

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.

References:

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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