The BEST-CLI trial: a multidisciplinary effort to assess whether surgical or endovascular therapy is better for

Matthew T Menard1, Alik Farber2

  • 1Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Boston, MA 02115.

Insights

Critical limb ischemia (CLI), a severe peripheral arterial disease, poses a limb loss risk. The BEST-CLI trial compares best endovascular versus surgical therapy to guide treatment decisions for CLI patients.

Area of Science:

  • Vascular Surgery
  • Interventional Cardiology
  • Peripheral Arterial Disease

Background:

  • Critical limb ischemia (CLI) is the most severe form of peripheral arterial disease, carrying a significant risk of limb loss.
  • Current treatments involve limb revascularization via surgery or endovascular intervention, with ongoing debate regarding optimal first-line therapy and success rates.
  • A lack of comparative effectiveness data hinders evidence-based treatment guidance for CLI.

Purpose of the Study:

  • To compare the effectiveness of the best available endovascular therapy versus the best available open surgical therapy in patients with CLI who are eligible for both procedures.
  • To provide urgently needed clinical guidance for the management of CLI through a pragmatic, multidisciplinary approach.
  • To evaluate novel primary endpoints and cost-effectiveness alongside quality-of-life outcomes.

Main Methods:

  • The Best Endovascular Versus Best Surgical Therapy in Patients With CLI (BEST-CLI) trial is a pragmatic, multicenter, open-label, randomized trial.
  • It directly compares best endovascular therapy against best open surgical treatment in eligible CLI patients.
  • The trial incorporates a multidisciplinary structure and novel methods for assessing cost-effectiveness and quality of life.

Main Results:

  • The BEST-CLI trial is designed to generate comparative effectiveness data for CLI treatment strategies.
  • It aims to resolve disagreements on the superiority of endovascular versus surgical interventions for CLI.
  • Results will inform clinical practice by comparing limb amputation rates, repeat interventions, and mortality between the two treatment groups.

Conclusions:

  • The BEST-CLI trial will provide crucial evidence to guide the selection of endovascular or surgical revascularization for critical limb ischemia.
  • Findings are expected to clarify the comparative effectiveness and outcomes of these major treatment modalities.
  • The study's multidisciplinary design and comprehensive endpoints will offer valuable insights into optimizing CLI management.

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