Certain persons with this artery-blocking disorder may benefit more from an open bypass than from less intrusive methods of improving circulation.
A clinical research trial funded by the National Institutes of Health discovered that performing open bypass surgery to restore circulation in patients with a severe form of peripheral artery disease (PAD) – a condition that restricts blood flow to the legs and feet – resulted in better outcomes than a less-invasive procedure.
More than 8.5 million persons in the United States suffer from PAD, a disorder in which a buildup of fatty plaque in the arteries restricts blood flow to one or both legs. Untreated, one in ten individuals with PAD develop chronic limb-threatening ischemia (CLTI), a painful and debilitating syndrome that can lead to amputation. CLTI is related with an increased risk of heart attack, stroke, and death, and affects approximately 22 million individuals globally.
“Given the projected increase in the number of patients with chronic limb-threatening ischemia, it is crucial that we understand the full impact of our interventions for this disease,” said Matthew Menard, M.D., an associate professor of surgery and co-director of the endovascular surgery program at Brigham and Women’s Hospital in Boston. These findings can also assist physicians and caregivers in providing patients with the best possible care.
BEST-CLI is a groundbreaking study financed by the National Heart, Lung, and Blood Institute. The findings were published in the New England Journal of Medicine and presented as late-breaking research at the Scientific Sessions 2022 of the American Heart Association.
To better understand the efficacy of two popular treatments for CLTI, researchers included 1,830 persons who were suitable for both treatment options and who were scheduled to undergo revascularization, a surgery intended to restore blood flow through blocked arteries.
Blood is rerouted around the obstructed leg artery using a portion of a healthy vein during an open bypass procedure. The other method was an endovascular operation, in which a balloon is inflated and/or a stent is implanted in the blocked part of the artery to increase blood flow. To compare the surgical strategy to the minimally invasive endovascular procedure, researchers randomly assigned individuals to one of two parallel trials conducted between 2014 and 2021 at 150 medical centers in the United States, Canada, Finland, Italy, and New Zealand.
The first experiment, designated cohort 1, included 1,434 adults who were deemed the greatest candidates for bypass surgery because they had an adequate amount of the ideal vein (the great saphenous vein with a single segment) favored for the treatment. The participants were subsequently randomised randomly to undergo either a surgical bypass or an endovascular operation. Seven years were spent observing the study participants by the researchers.
Cohort 2 consisted of 396 adults who were not ideal candidates for the open bypass because they lacked an adequate portion of the chosen saphenous vein. They were randomly assigned to undergo either an endovascular operation or a bypass using an alternative graft material in lieu of the saphenous vein. Up to three years were spent observing the study participants by the researchers.
At the conclusion of the experiment, the researchers discovered that patients in cohort 1 who got the bypass were 32% less likely than those who received an endovascular operation to experience significant medical events linked to CLTI. This result was the consequence of a 65% decrease in major repeat surgeries or treatments to maintain blood flow in the lower leg and a 27% decrease in major amputations. There were no differences in mortality rates between people who underwent bypass surgery and those who underwent an endovascular procedure.
Adults in cohort 2, who lacked the optimum vein for the bypass, did not see significant variations in outcomes based on whether they had undergone an open bypass or an endovascular surgery.
Co-principal investigator Alik Farber, M.D., chief of the Division of Vascular and Endovascular Surgery at Boston Medical Center, stated, “Our findings support complementary roles for these two treatment strategies and emphasize the need for preprocedural planning to assess patients and inform treatment selection.” “This study is an excellent illustration of how comparative effectiveness research might reveal the most promising surgical procedures for enhancing quality of life and long-term results for patients with the most severe instances of PAD,” stated NHLBI Director Gary H. Gibbons, M.D.
CLTI is characterized by leg and foot pain, foot infections, and persistent open sores on the leg and foot. Without a surgery to divert or open restricted blood supply to the lower body, approximately four out of ten persons with CLTI require amputation of the lower leg or foot.
BEST-CLI is the largest CLTI clinical trial to date, and it builds on previous research to answer issues regarding the risks and benefits of revascularization techniques for CLTI.
Visit https://www.nhlbi.nih.gov/health/peripheral-artery-disease for more information regarding CLTI and PAD.
NHLBI: About the National Heart, Lung, and Blood Institute The NHLBI is the global leader in performing and supporting research that enhances scientific knowledge, improves public health, and saves lives in the areas of heart, lung, and blood illnesses and sleep disorders. For additional details, please visit https://www.nhlbi.nih.gov.
NIH stands for the National Institutes of Health. The National Institutes of Health (NIH), the nation’s medical research organization, consists of 27 Institutes and Centers and is part of the U.S. Department of Health and Human Services. The NIH is the principal government organization that conducts and supports basic, clinical, and translational medical research and investigates the causes, treatments, and cures for both common and rare diseases. Visit www.nih.gov for more information on the NIH and its initiatives.
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Study
Farber A, Menard MT, Conte MS, et al. Chronic limb-threatening ischemia requires surgery or endovascular therapy. The New England Journal of Medicine, 2022; doi:10.1056/NEJMoa2207899.
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