More than 200 million people are affected by peripheral artery disease (PAD) globally. One in 10 of those individuals have a severe form of PAD known as chronic limb threatening ischemia (CLTI), which creates a higher risk of leg amputation, cardiovascular disease, and death.

Two treatments commonly combat CLTI and restore blood flow to the legs: surgical bypass (Bypass) and endovascular therapy (Endo). However, it was previously unknown which treatment option resulted in better patient outcomes.

A recent clinical trial led by Mass General Brigham investigators compared the two treatments and clinical outcomes to determine the optimal treatment approach. The study’s co-principal investigator was Matthew Menard, MD, co-director of the Endovascular Surgery Program at Brigham and Women’s Hospital. Dr. Menard and colleagues published their results in The New England Journal of Medicine and presented them at the American Heart Association 2022 Scientific Sessions.

Study Findings

BEST-CLI (Best Endovascular versus Best Surgical Therapy for Patients with Critical Limb Ischemia) investigated Bypass and Endo outcomes in 1,830 international patients. The participants were divided into two cohorts: individuals with an available, quality single-segment great saphenous vein (SSGSV)—considered the optimal conduit for Bypass—and individuals with only alternative conduit options, as ideal vein conduit is not available in all patients. Participants were followed for an average of 2.8 and 1.9 years, respectively, after being randomized to receive either Bypass or Endo as a 6treatment for CLTI.

The team reports that patients with available SSGSV who received Bypass had a 32% reduction in major adverse limb events or death compared to those who received Endo. In addition, those patients required 65% fewer major reinterventions and 27% fewer amputations. For patients without an available quality SSGSV, no difference in outcome measures was recorded.

Importantly, both Bypass and Endo revascularization reduced pain and led to clinically meaningful improvements in quality of life. The number of heart attacks, strokes, or deaths associated with the procedure was similar between the two treatments.

Interpreting the Results

While both Bypass and Endo treatments reduced pain and improved quality of life, these results emphasize the importance of individualized, patient-level decision-making when determining treatment approaches for CLTI.

Bypass and Endo revascularization are viable treatment options, but the findings suggest that patients with SSGSV may experience better outcomes when treated with Bypass.