Vein bypass first vs. best endovascular treatment first revascularisation strategy for chronic limb-threatening

Catherine A Moakes1, Andrew W Bradbury2,3, Zainab Abdali1

  • 1Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, UK.

Insights

For chronic limb-threatening ischemia, a best endovascular treatment-first strategy improved amputation-free survival and reduced costs compared to vein bypass-first. This approach offers a more effective and economical solution for patients.

Area of Science:

  • Vascular Surgery
  • Interventional Cardiology
  • Health Economics

Background:

  • Chronic limb-threatening ischemia (CLTI) presents significant risks, including major amputation and death.
  • Atherosclerotic peripheral arterial disease is a common cause of CLTI requiring infra-popliteal revascularization.

Purpose of the Study:

  • To compare the clinical and cost-effectiveness of vein bypass-first versus best endovascular treatment-first strategies for CLTI.
  • To determine which revascularization strategy best prevents major amputation or death in patients with CLTI.

Main Methods:

  • A superiority, open-label, pragmatic, multicenter, phase III randomized trial involving 345 patients across UK, Sweden, and Denmark.
  • Patients with CLTI underwent infra-popliteal revascularization, randomized to either vein bypass-first or best endovascular treatment-first.
  • Primary outcome was amputation-free survival, with secondary outcomes including overall survival, major amputation rates, and quality of life. Cost-effectiveness and cost-utility analyses were performed.

Main Results:

  • Best endovascular treatment-first demonstrated superior amputation-free survival (53% vs 63% non-survival; adjusted HR 1.35, P=0.037) and lower mortality (45% vs 53% deaths; adjusted HR 1.37).
  • The best endovascular treatment-first strategy was associated with lower hospital costs (£1690 less) and improved quality-adjusted life-years (0.016 and 0.085 gain at 2 and 3 years).

Conclusions:

  • A best endovascular treatment-first revascularization strategy is clinically superior and more cost-effective for CLTI patients.
  • This approach leads to better amputation-free survival, driven by reduced mortality, and offers economic advantages over vein bypass-first.
Abstract

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