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

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.