Performing open bypass surgery to restore circulation for people with a severe form of peripheral artery disease (PAD) — a condition that limits blood flow to the legs and feet — resulted in better outcomes for specific patients compared to a less-invasive procedure, a National Institutes of Health-supported clinical research trial has found.

More than 8.5 million adults in the United States live with PAD, a condition in which blood flow to one or both legs is reduced by a buildup of fatty plaque in the arteries. One in 10 develop a severe form of PAD called chronic limb-threatening ischemia (CLTI), a painful and debilitating condition that can lead to amputation if untreated. Up to about 22 million people worldwide have CLTI, which is also associated with an increased risk of heart attack, stroke, and death.

“Given the projected rise in the number of patients with chronic limb-threatening ischemia, it is critically important that we understand the full impact of our interventions for this disease,” said Matthew Menard, M.D., a study author and associate professor of surgery and co-director of the endovascular surgery program at Brigham and Women’s Hospital, Boston. “These findings help do that and also can assist clinicians and caregivers in providing the best possible care to patients.”

The Best Endovascular versus Best Surgical Therapy for Patients with CLTI (BEST-CLI) trial is a landmark study supported by the National Heart, Lung, and Blood Institute (NHLBI). The findings were published in the New England Journal of Medicine and simultaneously presented as late-breaking research at the American Heart Association’s Scientific Sessions 2022.

To better understand the effectiveness of two common treatments for CLTI, researchers enrolled 1,830 adults who were planning to have revascularization, a procedure used to restore blood flow in their blocked arteries, and who were eligible for both treatment strategies.

One treatment strategy was an open bypass surgery, in which blood is redirected around the blocked leg artery by using a segment of a healthy vein. The other strategy was an endovascular procedure — one performed inside the blood vessels where a balloon is dilated and/or a stent is placed in the blocked segment of the artery to improve blood flow. To compare the surgical strategy to the less-invasive endovascular approach, researchers randomized participants into one of two parallel trials conducted at 150 medical centers in the United States, Canada, Finland, Italy, and New Zealand between 2014-2021.

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