The BEST-CLI trial is nearing the finish line and promises to be worth the wait

Alik Farber; Kenneth Rosenfield; F Sandra Siami; Michael Strong; Matthew Menard

doi:10.1016/j.jvs.2018.05.255

The BEST-CLI trial is nearing the finish line and promises to be worth the wait

J Vasc Surg. 2019 Feb;69(2):470-481.e2. doi: 10.1016/j.jvs.2018.05.255.

Authors

Alik Farber¹, Kenneth Rosenfield², F Sandra Siami³, Michael Strong⁴, Matthew Menard⁵

Affiliations

¹ Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston, Mass; BEST-CLI Clinical Coordinating Center, Boston, Mass. Electronic address: alik.farber@bmc.org.
² BEST-CLI Clinical Coordinating Center, Boston, Mass; Division of Cardiology, Massachusetts General Hospital, Boston, Mass.
³ New England Research Institutes, Watertown, Mass.
⁴ BEST-CLI Clinical Coordinating Center, Boston, Mass.
⁵ BEST-CLI Clinical Coordinating Center, Boston, Mass; Division of Vascular and Endovascular Surgery, Brigham & Women's Hospital, Boston, Mass.

PMID: 30683195
DOI: 10.1016/j.jvs.2018.05.255

Abstract

There is significant variability and equipoise in the management of critical limb ischemia (CLI). The Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial, funded by the National Heart, Lung, and Blood Institute, is a prospective, open label, multicenter, multispecialty randomized controlled trial designed to compare treatment efficacy, functional outcomes, cost-effectiveness, and quality of life for 2100 patients suffering from CLI. BEST-CLI is enrolling those patients who are determined to be candidates for open surgical or endovascular revascularization and is designed to be comprehensive, pragmatic, and balanced. Enrollment is occurring at >130 sites across the world, and BEST-CLI is nearing the finish line. Although the trial has encountered a number of obstacles, they are being successfully navigated. This trial promises to establish an evidence-based standard of care in the management of this population of vulnerable patients.

Trial registration: ClinicalTrials.gov NCT02060630.

Keywords: Ischemia; Limb salvage; Peripheral artery disease; Pragmatic clinical trial; Vascular surgical procedure.

Publication types

Comparative Study
Multicenter Study
Pragmatic Clinical Trial
Research Support, N.I.H., Extramural

MeSH terms

Critical Illness
Endovascular Procedures* / adverse effects
Humans
Ischemia / diagnosis
Ischemia / physiopathology
Ischemia / surgery*
Lower Extremity / blood supply*
Peripheral Arterial Disease / diagnosis
Peripheral Arterial Disease / physiopathology
Peripheral Arterial Disease / surgery*
Prospective Studies
Quality of Life
Recovery of Function
Research Design
Risk Factors
Time Factors
Treatment Outcome
Vascular Surgical Procedures* / adverse effects

Associated data

ClinicalTrials.gov/NCT02060630