A number of new initiatives have recently been incorporated into the Best Endovascular versus best Surgical Therapy in patients with Critical Limb Ischemia (BEST-CLI) trial. It is hoped the additions and changes, including a modification of the protocol exclusion criteria, will facilitate subject accrual, an expansion to 140 trial sites and distribution of additional funds to all participating and enrolling centers.
The landmark BEST-CLI trial is a prospective, randomized, pragmatic, open-label superiority trial that is currently enrolling patients at 120 active sites in the United States and Canada. The trial will compare treatment efficacy, functional outcomes and cost in patients with critical limb ischemia who are candidates for both infrainguinal bypass and endovascular therapy and who are randomly assigned to one of the two treatments. Of the target number of 2,100 patients, 295 have been assigned treatments.
- The presence of >50% stenosis of the ipsilateral common femoral artery (CFA) will no longer be an exclusion. Treatment of a severe stenosis or an occlusion of the CFA either by open (surgical endarterectomy and patch angioplasty) or endovascular means will now be allowed and will be irrespective of the randomized treatment of the more distal occlusive disease.
- Immnosuppressive medication, a femoropopliteal TASC II A pattern of disease and hypercoaguagility will no longer be exclusions.
- The required delay following a previous open vascular or endovascular procedure (surgical bypass, balloon angioplasty, atherectomy or stenting) performed on the index limb has been reduced from six to three months. The required delay following a previous surgical inflow procedures performed on the index limb has been reduced from six months to six weeks.
- Treatment of an aortic or ipsilateral iliac artery occlusion will now be allowed.
- The protocol changes serve to bring the trial criteria more in line with common practice, while not altering to any significant degree the study aims.
The National Heart Lung and Blood Institute is sponsoring the trial, designed to address a number of questions of ongoing clinical interest. It aspires to significantly impact clinical practice by defining an evidence-based standard of care for patients with CLI. Recent changes in the trial design should serve to facilitate patient enrollment. Vascular surgeons participating are asked to continue their efforts to achieve current enrollment targets. Those not participating who wish to do so are asked to email BEST@neriscience.com.
Drs. Alik Farber (Boston Medical Center), Matthew Menard (Brigham and Women’s Hospital) and Kenneth Rosenfield (Massachusetts General Hospital) are leading the BEST-CLI Trial.
All are invited to upcoming BEST-CLI Trial Investigators Meetings at VIVA (3 to 4:30 p.m. PST on Tuesday, Nov. 3) and VEITH (3 to 4:30 p.m. EST on Friday, Nov 20).
For more information visit www.bestcli.com