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Mass General Brigham Study Suggests Optimal Treatment for Limb Threatening Ischemia

In This Article

  • A severe form of peripheral artery disease known as chronic limb threatening ischemia (CLTI) leads to a higher risk of leg amputation, cardiovascular disease, and death
  • CLTI is commonly treated with either surgical bypass (Bypass) or endovascular therapy (Endo)
  • The BEST-CLI clinical trial, led by Mass General Brigham investigators, compared the two treatment approaches to determine which leads to better patient outcomes
  • The researchers report that patients treated with Bypass had fewer major adverse limb events or death compared to those treated with Endo
  • These findings emphasize the need for pre-intervention assessments to determine optimal treatment and improve patient outcomes

Peripheral artery disease (PAD) affects over 200 million people globally, one in 10 of whom have a severe form known as chronic limb threatening ischemia (CLTI). This condition puts individuals at risk of leg amputation, cardiovascular disease, and death.

Two treatments are commonly used to combat CLTI and restore blood flow to the legs: surgical bypass (Bypass) and endovascular therapy (Endo). A recent clinical trial led by Mass General Brigham investigators, including co-principal investigator Kenneth Rosenfield, MD, head of the Section of Vascular Medicine and Intervention in the Corrigan Minehan Heart Center at Massachusetts General Hospital, compared the two approaches to determine which resulted in better outcomes.

The results from the BEST-CLI (Best Endovascular versus Best Surgical Therapy for Patients with Critical Limb Ischemia) trial were published in The New England Journal of Medicine and presented at the American Heart Association 2022 Scientific Sessions.

The Findings

BEST-CLI involved two parallel trials investigating Bypass and Endo outcomes in 1,830 international patients. The first trial's patient cohort included individuals with an available, good-quality single segment great saphenous vein (SSGSV), which is considered the optimal conduit for Bypass. As not all patients have ideal vein conduits available, the second cohort included individuals with only alternative conduit options. Patients in both cohorts were randomized to receive either Bypass or Endo as a treatment for CLTI and were followed for an average of 2.8 and 1.9 years, respectively.

The study revealed that patients with available SSGSV who received Bypass had a 32% reduction in major adverse limb events (MALE) 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.

Another important finding was that 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 were similar between the two treatments.

Study Implications

The BEST-CLI investigators emphasize the importance of individualized, patient-level decision-making when determining treatment approaches for CLTI. Both Bypass and Endo are viable treatment options, but this study suggests that patients with SSGSV may experience improved outcomes when treated with Bypass.

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Anahita Dua, MD, MSc, MBA, director of the Vascular Lab at Massachusetts General Hospital, and Ido Weinberg, MD, medical director of VasCore, presented on peripheral artery disease.