Design and Rationale of the Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial

Matthew T Menard, Alik Farber, Susan F Assmann, Niteesh K Choudhry, Michael S Conte, Mark A Creager, Michael D Dake, Michael R Jaff, John A Kaufman, Richard J Powell, Diane M Reid, Flora Sandra Siami, George Sopko, Christopher J White, Kenneth Rosenfield, Matthew T Menard, Alik Farber, Susan F Assmann, Niteesh K Choudhry, Michael S Conte, Mark A Creager, Michael D Dake, Michael R Jaff, John A Kaufman, Richard J Powell, Diane M Reid, Flora Sandra Siami, George Sopko, Christopher J White, Kenneth Rosenfield

Abstract

Background: Critical limb ischemia (CLI) is increasing in prevalence, and remains a significant source of mortality and limb loss. The decision to recommend surgical or endovascular revascularization for patients who are candidates for both varies significantly among providers and is driven more by individual preference than scientific evidence.

Methods and results: The Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial is a prospective, randomized, multidisciplinary, controlled, superiority trial designed to compare treatment efficacy, functional outcomes, quality of life, and cost in patients undergoing best endovascular or best open surgical revascularization. Approximately 140 clinical sites in the United States and Canada will enroll 2100 patients with CLI who are candidates for both treatment options. A pragmatic trial design requires consensus on patient eligibility by at least 2 investigators, but leaves the choice of specific procedural strategy within the assigned revascularization approach to the individual treating investigator. Patients with suitable single-segment of saphenous vein available for potential bypass will be randomized within Cohort 1 (n=1620), while patients without will be randomized within Cohort 2 (n=480). The primary efficacy end point of the trial is Major Adverse Limb Event-Free Survival. Key secondary end points include Re-intervention and Amputation-Free-Survival and Amputation Free-Survival.

Conclusions: The BEST-CLI trial is the first randomized controlled trial comparing endovascular therapy to open surgical bypass in patients with CLI to be carried out in North America. This landmark comparative effectiveness trial aims to provide Level I data to clarify the appropriate role for both treatment strategies and help define an evidence-based standard of care for this challenging patient population.

Clinical trial registration: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02060630.

Keywords: atherosclerosis; cost‐effectiveness; critical limb ischemia; endovascular; outcome; quality; stent treatment; surgery.

© 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Figures

Figure 1
Figure 1
Critical limb ischemia: % treated by bypass (vs Endovascular).21
Figure 2
Figure 2
Patient flow chart. Stratum I: Ischemic Rest Pain (Rutherford Category 4) AND infrainguinal PAD without significant infrapopliteal occlusive disease; Stratum II: Tissue loss with or without ischemic rest pain (Rutherford category 5, 6) AND Infrainguinal PAD without significant infrapopliteal occlusive disease; Stratum III: Ischemic Rest Pain (Rutherford Category 4) AND Infrainguinal PAD with significant infrapopliteal occlusive disease; Stratum IV: Tissue loss with or without ischemic rest pain (Rutherford category 5, 6) AND Infrainguinal PAD with significant infrapopliteal occlusive disease. CLI indicates critical limb ischemia; EVT, endovascular therapy; PAD, peripheral artery disease; SSSGSV, single‐segment great saphenous vein.
Figure 3
Figure 3
BEST‐CLI trial organizational chart. BEST‐CLI indicates Best Endovascular versus Best Surgical Therapy in patients with Critical Limb Ischemia trial.
Figure 4
Figure 4
Site map.

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