News | Peripheral Artery Disease (PAD) | November 15, 2022

Bypass Surgery Favorable for Initial Treatment of Chronic Limb-Threatening Ischemia

Certain adults with this artery-blocking condition may see more benefits with an open bypass compared to less-invasive procedures to improve circulation 

Certain adults with this artery-blocking condition may see more benefits with an open bypass compared to less-invasive procedures to improve circulation.

Getty Images


November 15, 2022 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(link is external) and simultaneously presented as late-breaking research(link is external) 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. 

The first trial, defined as cohort 1, included 1,434 adults who were judged to be the best candidates for the bypass surgery because they had an adequate amount of an optimal vein (the single-segment great saphenous vein) preferred for the procedure. Participants were then randomly assigned to have either a surgical bypass or endovascular procedure. Researchers followed the trial participants for up to seven years.  

The second trial, defined as cohort 2, included 396 adults who were not the best candidates for the open bypass because they did not have an adequate amount of the preferred saphenous vein. They were randomized to have either an endovascular procedure or a bypass that used alternate graft material instead of the saphenous vein. Researchers followed the trial participants for up to three years.   

At the end of the trial, the researchers found that participants in cohort 1 who received the bypass were 32% less likely to have major medical events related to CLTI than those who had an endovascular procedure. This result was driven by a 65% reduction in major repeat surgeries or procedures to retain blood flow in the lower leg and a 27% reduction in major amputations. No differences were found in death rates between the participants who received the bypass surgery and those who received an endovascular procedure. 

Adults in cohort 2 – those who did not have the optimal vein for the bypass – had no major differences in outcomes based on having had an open bypass or an endovascular procedure.  

“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,” said co-principal investigator Alik Farber, M.D., chief of the Division of Vascular and Endovascular Surgery at Boston Medical Center. “This study is a superb exemplar of how comparative effectiveness research can show us the most promising surgical interventions toward improving quality of life and long-term outcomes for those who suffer from the most severe cases of PAD," said NHLBI Director Gary H. Gibbons, M.D. 

Common symptoms of CLTI include leg and foot pain, foot infections, and open sores on the leg and foot that don’t fully heal. Without having a procedure to redirect or open blocked blood flow to the lower body, about 4 in 10 adults with CLTI have a lower leg or foot amputation. 

BEST-CLI is the largest CLTI clinical trial to date and builds on prior research that aims to answer questions about the risks and benefits of revascularization strategies for CLTI.  

For more information: https://www.nhlbi.nih.gov/health/peripheral-artery-disease 


Related Content

News | Heart Failure

December 2, 2022 — Westchester resident, 62-year-old Miriam Nieves, is especially grateful this Thanksgiving season ...

Home December 02, 2022
Home
News | Heart Failure

December 2, 2022 — The U.S. Senate today passed the bipartisan Cardiovascular Advances in Research and Opportunities ...

Home December 02, 2022
Home
News | Heart Failure

December 1, 2022 — Scientists at the Centro Nacional de Investigaciones Cardiovasculares (CNIC) have identified a new ...

Home December 01, 2022
Home
News | Heart Failure

November 22, 2022 — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with ...

Home November 22, 2022
Home
News | Heart Failure

November 21, 2022 — Cardiovascular disease remains the leading cause of death in the United States (US) and worldwide ...

Home November 21, 2022
Home
News | Heart Failure

November 22, 2022 — Myocarditis is a complication that can occur in cancer patients treated with immune checkpoint ...

Home November 21, 2022
Home
News | Heart Failure

November 15, 2022 — Ten months after transplanting the first genetically-modified pig heart into a human patient ...

Home November 15, 2022
Home
News | Heart Failure

November 14, 2022 — When it comes to heart failure (HF), sex differencesare known to impact everything from risk factors ...

Home November 14, 2022
Home
News | Heart Failure

November 9, 2022 — Lexicon Pharmaceuticals, Inc. announced that a new analysis of results from the SOLOIST-WHF Phase 3 ...

Home November 09, 2022
Home
News | Heart Failure

November 3, 2022 — Chronic heart failure causes the cell’s powerhouses to dysfunction, in part due to overconsumption of ...

Home November 03, 2022
Home
Subscribe Now