November 7, 2022

First-of-Its-Kind Study Determines Best Treatment for Severe Peripheral Artery Disease

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More than 200 million people have peripheral artery disease, but the best path of treatment for the most severe cases hasn't been studied until now.

The Bottom Line

A new study has answered a longstanding question about whether surgical bypass or endovascular therapy is the best course of action for patients with a severe form of peripheral artery disease (PAD) known as chronic limb threatening ischemia (CLTI) or critical limb ischemia. These patients are at risk of leg amputation, cardiovascular disease, and death. The trial, the largest of its kind, found that there should not be a default, one-size-fits-all treatment, and that the decision to pursue bypass or endo should be made with the specific patient in mind.


Worldwide, more than 200 million people have PAD, and approximately 1 in 10 of those people have ClTI. Both bypass and endo are used to revascularize limbs, reduce cardiovascular risk, and improve quality of life overall — however, there has been a lack of data comparing the treatments and their outcomes. Choosing a surgical intervention or endovascular therapy has instead been determined based on physician training and skill set, patient preference, and contraindications or surgical risk, though use of the less invasive endo has increased in recent years.

Study Objective

To compare the effectiveness of revascularization strategies for CLTI, bypass versus endo.

The Details

The randomized, multicenter clinical trial was led by investigators from Boston Medical Center, Brigham and Women’s Hospital, and Massachusetts General Hospital. In two parallel trials, U.S.-based and international patients enrolled in the study were randomized to receive either bypass or endo. Cohort 1 included 1,434 patients with single segment great saphenous vein (SSGSV) — which has been established in prior studies to have better outcomes of a bypass intervention. Cohort 2 included 396 patients lacking suitable SSGSV. Patients in these groups were followed for approximately 3 and 2 years, respectively. Researchers were looking to measure the timeline until a reintervention was needed, the patient needed an above-ankle amputation, or the patient died.


Overall, in patients with adequate SSGSV, bypass showed a 32% reduction in major adverse limb events or death compared to endo, including 65% fewer reinterventions and 27% fewer amputations. Also, patients who had either bypass or endo had similar rates of adverse cardiovascular events and mortality.  There was no difference in safety outcomes among patients in cohort 2.

Pull Quote

“Our study provides high-quality clinical evidence to inform the conversations clinicians will have with their CLTI patients about how to best provide treatment to them,” says Alik Farber, MD, MBA, chief of Vascular and Endovascular Surgery at Boston Medical Center, and co-principal investigator of the study. “Our findings support complementary roles for these two treatment strategies and emphasize the need for pre-procedural planning to assess patients and inform what treatment is selected.”


Farber A, Menard MT, et al. (2022). “Bypass or Endovascular Therapy for Treatment of Chronic Limb Threatening Ischemia.New England Journal of Medicine.

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