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The BEST-CLI trial: a multidisciplinary effort to assess which therapy is best for patients with critical limb

Alik Farber1, Kenneth Rosenfield2, Matthew Menard3

  • 1Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston, MA.

Techniques in Vascular and Interventional Radiology
|September 22, 2014
PubMed

Insights

The BEST-CLI trial compares endovascular therapy to open surgery for critical limb ischemia (CLI), aiming to guide treatment decisions for patients with peripheral arterial disease and prevent limb loss.

Area of Science:

  • Vascular Surgery
  • Interventional Cardiology
  • Peripheral Arterial Disease Management

Background:

  • Critical limb ischemia (CLI) is the most severe form of peripheral arterial disease, carrying a high risk of limb loss.
  • Current treatment involves limb revascularization, with ongoing debate regarding the optimal approach between open vascular bypass and endovascular therapy for infrainguinal disease.
  • A lack of comparative effectiveness data has hindered definitive treatment guidance for CLI patients eligible for both interventions.

Purpose of the Study:

  • To compare the effectiveness of the best available endovascular therapy versus the best available open surgical treatment in patients with CLI who are eligible for both procedures.
  • To provide urgently needed clinical guidance for the management of critical limb ischemia.
  • To evaluate the cost-effectiveness and quality-of-life outcomes of both treatment strategies.

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 compares best endovascular therapy against best open surgical treatment in patients eligible for both.
  • The trial employs a novel primary endpoint including limb amputation rates, repeat interventions, and mortality.

Main Results:

  • The study is designed to provide comparative effectiveness data for CLI management.
  • It allows for the incorporation of newer therapies as they emerge.
  • The trial facilitates a multidisciplinary approach involving various vascular specialists.

Conclusions:

  • The BEST-CLI trial is expected to resolve clinical equipoise regarding endovascular versus surgical revascularization for CLI.
  • Findings will inform clinical decision-making for patients with peripheral arterial disease and critical limb ischemia.
  • The study will offer crucial insights into optimizing limb salvage and patient outcomes.

Keywords:
controlled randomized trialcritical limb ischemiaendovascular therapysurgical bypass

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