BEST-CLI Trial Quality of Life Analyses

Nov, 2022 - By SMI

Researchers evaluated the health-related quality of life for people who received treatment in this study phase.

According to lead study author Matthew Menard, M.D., an associate professor of surgery at Harvard Medical School and co-director of endovascular surgery at the Brigham and Women's Hospital, both in Boston, this is the first-ever randomised controlled trial of this size and it is a landmark effort in its breadth and depth. PAD does not have the substantial amount of high-quality evidence that informs treatment for heart disease and stroke, and up to this point, there has been essentially no data to guide the care of CLTI patients. In order to improve future attempts to care for this particularly vulnerable patient population, we anticipate that this study will act as a standard.

Leg bypass surgery, in which a passageway through the blocked arteries is established using a patient's leg vein or an artificial blood artery, is a frequent treatment for those with high amputation risk owing to PAD. An alternative, less invasive method is angioplasty with or without stenting, in which a stent is put to keep the artery open and a thin balloon-tipped catheter is used to widen the blockage. "Endovascular" operations include balloon angioplasty and stenting.

The Best Endovascular Therapy for Patients with Chronic Limb Threatening Ischemia in Comparison to the Best Surgical Therapy (BEST-CLI) 1,830 patients with severe PAD were included in the trial at 150 facilities in the United States, Canada, Italy, Finland, and New Zealand. In the trial's first phase, patients who underwent endovascular procedures and those who underwent bypass surgery were compared for safety, the need for additional procedures, and amputations. According to that portion of the study, persons who undergo bypass surgery using their own leg vein as the bypass conduit fare better than those who undergo an endovascular operation.