Boston Hospital Trio Awarded $25 Million Grant

Boston-area researchers from Brigham and Women’s Hospital (BWH), Boston Medical Center (BMC), and Massachusetts General Hospital (MGH) are teaming up to conduct a four-year clinical trial to compare traditional bypass surgery with a less invasive treatment for patients with critical limb ischemia (CLI), severe blockage in the arteries of the lower extremities.

The group was awarded $25 million by the National Institutes of Health (NIH) to conduct the randomized clinical trial which is called the “BEST-CLI Trial,” short for the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia.

According to Boston Medical Center officials, CLI is the most severe form of peripheral arterial disease, which is caused by chronic inflammation and atherosclerotic plaque build-up in the arteries of the legs. Symptoms caused by reduced blood flow to the legs and feet include ischemic leg pain, non-healing wounds, and gangrene. If untreated, CLI can often lead to leg amputation. The aging of the national population and the rising rate of diabetes have led to an increase in both peripheral arterial disease and CLI.

According to the study investigators, while both open surgery and endovascular interventions are used to treat CLI, it is not clear which approach works best in patients who are candidates for both treatment options.

“Currently, there is a lack of consistency and clarity as to what approach—minimally invasive endovascular or open surgery—is best for our patients,” says Dr. Alik Farber, division chief of vascular and endovascular surgery at BMC. “The BEST-CLI Trial will provide answers to many unanswered questions, most importantly what treatment works best for whom.”

The BEST-CLI trial will provide clinical guidance for CLI management in four ways:

• a pragmatic design comparing the effectiveness of established techniques while allowing for the introduction of newer therapies as they become available
• a novel primary endpoint that includes limb amputation rates, repeat treatments, and loss of life
• a multidisciplinary structure that fosters cooperation among vascular surgeons, interventional cardiologists, interventional radiologists, and vascular medicine specialists
• novel techniques to evaluate the cost-effectiveness and quality-of-life outcomes of the two treatment strategies being tested.

The trial will enroll 2,100 participants and be conducted at 120 clinical centers in the United States and Canada. The New England Research Institutes in Watertown will serve as the data coordinating center.