Yale University: Bypass Surgery Has Lower Risks Than Endovascular Therapy for Limb-threatening Ischemia

Bypass surgery performed on arteries leading to the legs was associated with a lower risk of cardiac events among patients with peripheral arterial disease who are candidates for two types of revascularization therapy, new research suggests.

Chronic limb-threatening ischemia or CLTI is characterized by restricted blood flow to the lower limbs caused by a buildup of fatty deposits called plaque. The disease is associated with amputation, increased mortality, and impaired quality of life. Physician training and treatment bias influence decision-making for revascularization strategies. However, the variability of clinical outcomes for patients with CLTI is less understood.

Published in the New England Journal of Medicine, the BEST-CLI clinical trial (Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia) aimed to determine whether endovascular therapy or bypass surgery resulted in improved clinical outcomes. The results were presented at the American Heart Association Scientific Sessions on Nov. 7.

Funded by the National Heart, Lung and Blood Institute at the National Institutes of Health, Best CLI is a landmark comparative effectiveness trial in patients with peripheral arterial disease who were eligible for two revascularization strategies, endovascular and surgical. The research team enrolled 1,843 participants with CLTI into two study arms.

Many of our patients benefited from it and certainly will change the landscape for millions more across the globe.

Carlos Mena-Hurtado, MD
In the first cohort, 1,434 patients were selected for surgery or endovascular therapy and followed-up for several years. There were minimal differences in the time to heart attack or stroke between the surgery and endovascular arm. A higher majority of patients treated with endovascular therapy experienced an adverse limb event. The results were similar for the smaller cohort. Out of 396 patients, almost half who were randomly selected for endovascular therapy experienced an adverse event within 1.6 years on average. Although the use of endovascular therapy has increased, the results demonstrate certain patients may benefit from a surgical intervention

Carlos Mena-Hurtado, MD, associate professor and a co-author of the study, noted that CLTI is a significant source of mortality and limb loss globally.

“Yale New Haven Hospital was among the top enrolling sites. Within our Heart and Vascular Center (HVC) We collaborated with vascular surgery, podiatry, radiology, internal medicine, wound care centers and mid-level providers across the health system. It was a huge effort many of our patients benefited from it and certainly will change the landscape for millions more across the globe,” said Mena.