A clinical research trial funded by the National Institutes of Health found that open bypass surgery was superior to a less invasive method for certain patients who had a severe form of peripheral artery disease (PAD), a condition that restricts blood flow to the legs and feet.
More than 8.5 million people in the US suffer from peripheral artery disease, a disorder in which a buildup of fatty plaque in the arteries reduces blood flow to one or both legs. Chronic limb-threatening ischemia (CLTI), a painful and crippling illness that can result in amputation if left untreated, is a severe type of peripheral artery disease that affects one in ten people. There are up to 22 million CLTI cases worldwide, and these cases are linked to a higher risk of death, heart attack, and stroke.
According to Matthew Menard, M.D., a study author, associate professor of surgery, and co-director of the endovascular surgery program at Brigham and Women’s Hospital in Boston, “it is critically important that we understand the full impact of our interventions for this disease given the projected rise in the number of patients with chronic limb-threatening ischemia.” These findings support that and can help physicians and caregivers give patients the best treatment possible.
The National Heart, Lung, and Blood Institute is supporting the Best Endovascular versus Best Surgical Therapy for Patients with CLTI (BEST-CLI) experiment, a groundbreaking investigation (NHLBI). The results were presented as late-breaking research at the American Heart Association’s Scientific Sessions 2022 while also being published in the New England Journal of Medicine.
Researchers included 1,830 persons who planned to have revascularization, a technique intended to restore blood flow in their blocked arteries, and who were suitable for both therapy strategies in order to better understand the efficacy of two standard treatments for CLTI.
One treatment option was open bypass surgery, in which a healthy vein segment was used to reroute blood around the occluded leg artery. An endovascular operation, which is carried out inside blood vessels and entails the placement of a stent or a balloon dilation to enhance blood flow, was the other tactic. Participants were randomly assigned to one of two parallel trials that were carried out in 150 medical facilities in the United States, Canada, Finland, Italy, and New Zealand between 2014 and 2021 in order to compare the surgical technique to the less invasive endovascular approach.
1,434 persons who were deemed to be the greatest candidates for bypass surgery because they possessed a sufficient portion of the ideal vein (the single-segment great saphenous vein) were included in the first study, also known as cohort 1. After that, participants were assigned at random to either an endovascular operation or a surgical bypass. For up to seven years, researchers monitored the trial participants.
Cohort 2 of the second trial consisted of 396 adults who weren’t the best candidates for an open bypass because they lacked enough of the desired saphenous vein. They had either an endovascular treatment or a bypass using a different type of graft material in place of the saphenous vein, according to a randomization process. For up to three years, researchers monitored the trial participants.
Researchers discovered that patients in Cohort 1 who received the bypass were 32% less likely than those who underwent an endovascular surgery to experience significant medical events linked to CLTI. This outcome was caused by a 27% decrease in major amputations and a 65% decrease in major recurrent surgeries or treatments to maintain blood flow in the lower leg. The participants who underwent bypass surgery and those who underwent an endovascular technique both experienced the same fatality rates.
There were no significant differences in the outcomes of adults in Cohort 2 who did not have the best vein for the bypass based on whether they had undergone an open bypass or an endovascular surgery.
According to co-principal investigator Alik Farber, M.D., head of the Division of Vascular and Endovascular Surgery at Boston Medical Center, “Our findings support complementary roles for these two treatment strategies and emphasize the need for preprocedural planning to assess patients and inform what treatment is selected.”
According to NHLBI Director Gary H. Gibbons, M.D., “This study is an excellent example of how comparative effectiveness research can show us the most promising surgical approaches toward improving quality of life and long-term outcomes for people who suffer from the most severe forms of peripheral artery disease.”
Leg and foot pain, infections in the feet, and open sores on the legs and feet that don’t fully heal are typical signs of CLTI. About 4 in 10 persons with CLTI amputate their lower leg or foot without having a treatment to reroute or open restricted blood supply to the lower torso.
BEST-CLI, the largest CLTI clinical trial to date, expands on earlier studies that sought to clarify the advantages and disadvantages of revascularization techniques for CLTI.
