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Updated: Apr 15, 2026

Assessing Therapeutic Angiogenesis in a Murine Model of Hindlimb Ischemia
Published on: June 8, 2019
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.
Abstract:
Critical limb ischemia (CLI) is the most severe form of peripheral arterial disease and is associated with a risk of limb loss. This vascular condition is currently treated with limb revascularization by surgery or endovascular intervention performed by a variety of specialists. Because both open vascular bypass and the less invasive endovascular therapy can be performed in selected patients with CLI, there exists significant disagreement as to which therapy should be performed first and which is more successful. The paucity of comparative effectiveness data to guide treatment of CLI has prompted a multidisciplinary effort to organize the Best Endovascular Versus Best Surgical Therapy in Patients With CLI (BEST-CLI) trial. The BEST-CLI trial is a pragmatic, multicenter, open-label, randomized trial that compares best endovascular therapy with best open surgical treatment in patients eligible for both treatments. BEST-CLI aims to provide urgently needed clinical guidance for CLI management by using a pragmatic design comparing the effectiveness of established techniques while allowing for the introduction of newer therapies as they become available; a novel primary endpoint that includes limb amputation rates, repeat intervention, and mortality; a multidisciplinary structure that fosters cooperation among interventional cardiologists, interventional radiologists, vascular surgeons, and vascular medicine specialists; and novel techniques to evaluate the cost-effectiveness and quality-of-life outcomes of the two treatment strategies being tested.
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