The Novo Nordisk Foundation has made a $3.3 million contribution toward the BEST-CLI (Best endovascular vs. best surgical therapy in patients with critical limb ischemia) clinical trial, the Denmark-based entity has announced. The grant is set to be used by investigators to continue analyzing the wealth of data produced by the nearly eight-year-long study.
Originally funded by the U.S. National Institutes of Health (NIH), BEST-CLI trial compares the treatment efficacy, functional outcomes, quality of life and cost–effectiveness of surgical bypass and endovascular revascularization for 1,840 patients with CLI across North America, Europe and Asia.
The trial is being led by co-principal investigators Matthew Menard, MD, director of the vascular and endovascular fellowship program at Brigham and Women’s Hospital in Boston; Alik Farber, MD, chief of vascular and endovascular surgery at Boston Medical Center; and Kenneth Rosenfield, MD, section head of vascular medicine and intervention at Massachusetts General Hospital, also in Boston.
The much-anticipated clinical results—as well as quality-of-life analyses—from BEST-CLI are due to be presented at the American Heart Association (AHA) Scientific Sessions (Nov. 5–7) in a late-breaking session on Monday morning (Nov. 7).
The trial started in August 2014 and was completed in March of this year. Patients were followed for at least two years and up to seven years.
The fresh funding injection from the Novo Nordisk Foundation will be used by the investigators to continue plumbing the trial data, perform a comprehensive cost–effectiveness analysis, and establish an imaging core laboratory to collate and analyze the radiographic imaging collected.
“BEST-CLI is a landmark trial that has the ambitious goal of establishing the evidence foundation that will help clinicians and caregivers provide the best possible care to patients with critical limb ischemia,” said Menard.
“Unprecedented in its effort to bring together all of the specialties that treat CLI, as well as in its global reach, BEST-CLI aims to define a sorely needed standard of care for this particularly vulnerable population of patients. Given the truly alarming rates of diabetes around the world, and the projected rise in the number of patients afflicted with critical limb ischemia, it is of paramount importance that we understand the full impact of our surgical and endovascular interventions.”
In addition to the initial NIH funding, the Society for Vascular Surgery (SVS), the Society for Clinical Vascular Surgery (SCVS) and a slew of other national and regional vascular societies are among those to have contributed funds toward BEST-CLI. Industry sources of financial support included Janssen, Gore, BD, Medtronic, Cook Medical, Boston Scientific, Abbott, Cordis and Cardiovascular Systems, Inc.