title: Design and Rationale of the Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02060630.
authors.affiliation: Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Boston, MA mmenard@partners.org.
authors.forename: Matthew T
authors.initials: MT
authors.lastname: Menard
authors.affiliation: Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston, MA.
authors.forename: Alik
authors.initials: A
authors.lastname: Farber
authors.affiliation: New England Research Institute, Watertown, MA.
authors.forename: Susan F
authors.initials: SF
authors.lastname: Assmann
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA.
authors.forename: Niteesh K
authors.initials: NK
authors.lastname: Choudhry
authors.affiliation: Division of Vascular and Endovascular Surgery, University of California San Francisco Medical Center, San Francisco, CA.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Conte
authors.affiliation: Dartmouth-Hitchcock Heart and Vascular Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Creager
authors.affiliation: Department of Cardiothoracic Surgery, Stanford Hospital and Clinics, Stanford, CA.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Dake
authors.affiliation: Fireman Vascular Center, Massachusetts General Hospital, Boston, MA.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
authors.affiliation: Dotter Interventional Institute/OHSU, Portland, OR.
authors.forename: John A
authors.initials: JA
authors.lastname: Kaufman
authors.affiliation: Division of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Powell
authors.affiliation: National Heart, Lung and Blood Institute, Bethesda, MD.
authors.forename: Diane M
authors.initials: DM
authors.lastname: Reid
authors.affiliation: New England Research Institute, Watertown, MA.
authors.forename: Flora Sandra
authors.initials: FS
authors.lastname: Siami
authors.affiliation: National Heart, Lung and Blood Institute, Bethesda, MD.
authors.forename: George
authors.initials: G
authors.lastname: Sopko
authors.affiliation: Department of Cardiology, Ochsner Medical Center, New Orleans, LA.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: White
authors.affiliation: Division of Cardiology, Massachusetts General Hospital, Boston, MA.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Rosenfield
mesh_terms: D000671:Amputation, Surgical / Q000706:statistics & numerical data; D000714:Anastomosis, Surgical; D057186:Comparative Effectiveness Research; D003362:Cost-Benefit Analysis; D057510:Endovascular Procedures / Q000191:economics / Q000379:methods*; D000074099:Equivalence Trials as Topic; D005121:Extremities / Q000098:blood supply*; D006801:Humans; D007511:Ischemia / Q000601:surgery*; D058729:Peripheral Arterial Disease / Q000601:surgery*; D015607:Stents; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures / Q000191:economics / Q000379:methods*
keywords: atherosclerosis; cost‐effectiveness; critical limb ischemia; endovascular; outcome; quality; stent treatment; surgery