BEST-CLI Supports Surgery in Patients With Adequate GSV, With Roles for Open and Endovascular Approaches

November 7, 2022—The Society for Vascular Surgery announced findings from the landmark BEST-CLI clinical trial showing that surgery was a better treatment option than endovascular therapy in patients at risk for amputation because of severe peripheral artery disease (PAD) who have a good single-segment great saphenous vein (SSGSV) and are deemed to be equal candidates for open surgery and endovascular revascularization.

BEST-CLI—Best Endovascular Versus Best Surgical Therapy in Patients with Critical Limb Ischemia—clinical trial compared two standard treatments for restoring blood flow: surgery with the patient’s own SSGSV, with artificial grafts, or with another vein versus endovascular therapy such as angioplasty with or without stenting.

The international study was funded by the National Heart, Lung, and Blood Institute at the National Institutes of Health. It was created to determine “the effectiveness of the best available surgical treatment with the best endovascular treatment in adults with CLI who are eligible for both treatment options,” noted SVS.

According to the SVS press release, the trial was led by principal investigators Alik Farber, MD; Matthew Menard, MD; and Kenneth Rosenfield, MD. Drs. Farber and Menard are vascular surgeons and Dr. Rosenfield is a cardiologist with a subspecialty in interventional cardiology. Dr. Farber is with Boston Medical Center; Dr. Menard is with Brigham and Women’s Hospital; and Dr. Rosenfield is with Massachusetts General Hospital, all three are in Boston, Massachusetts.

The investigators presented the study at the American Heart Association 2022 Scientific Sessions held November 5-7 in Chicago, Illinois. Additionally, the findings were published by Dr. Farber et al online ahead of print in The New England Journal of Medicine.

As summarized in the SVS press release, the trial enrolled 1,830 patients across 150 sites in the United States, Canada, Finland, Italy, and New Zealand. Each patient underwent vein mapping of the GSV, and then was assigned to one of two cohorts in this “two trials” study:

• Cohort 1 included patients with a SSGSV (1,424 patients)
• Cohort 2 included those without a SSGSV, for whom an alternative autogenous vein or a prosthetic would be used (396 patients)

Patients were then randomized 1:1 to either endovascular or surgical treatment and followed for a median of 2.7 years and up to 7 years for Cohort 1 and a median of 1.9 years for Cohort 2. The choice of specific treatment following randomization was at the discretion of the clinician.

In the press release, Dr. Farber reported the following statistically significant findings: in the group that included patients who underwent bypass surgery with a SSGSV, there was a 32% overall reduction in major adverse limb events or death, based on a 65% reduction in major reinterventions, and a 27% reduction in above-ankle amputation.

The second cohort included patients who had either endovascular procedures or bypass surgery using an arm vein or artificial graft. There were no statistically significant differences in outcomes, such as additional interventions or amputations, between patients who had bypass surgery with disadvantaged conduit and those who had endovascular procedures.

“To date, the implications of beginning treatment for chronic limb-threatening ischemia (CLTI) with a surgical bypass versus endovascular therapy has been unclear,” commented Dr. Menard in the SVS press release. “We constructed this trial to try to develop an evidence base that would help clarify the short- and long-term impact and safety of initial therapy and in so doing guide us as caregivers when treating these very challenging patients.

“An important finding was that mortality rates and major cardiovascular safety events were low and equal between the two study groups. These patients are very ill, but BEST-CLI clearly showed they can undergo surgery with relatively low morbidity and mortality.” Dr. Menard concluded, “From a global perspective this is an important landmark trial.”

Also in the SVS press release, Dr. Rosenfield noted that the study demonstrated the importance of an appropriate initial assessment of patients’ vein status. He advised that for those patients with a good saphenous vein, bypass surgery “should be considered as the first approach.”

Dr. Rosenfield further stated, "This is the first trial of this magnitude demonstrating that both approaches improve outcome and quality of life for these challenging patients, and that both are durable. Importantly, the findings show that open surgery plays an important role as initial revascularization strategy for certain patients with CLTI. Ultimately, the choice between surgery and endovascular therapy comes down to individual patient decision-making, ideally involving collaborating specialties.”

Dr. Rosenfield added, “It’s the beginning of a process of evidence development in this area; adds a lot of information and answers some important questions. There is much more work to be done in CLTI and PAD in general, but I think it’s a huge step forward in this space for our patients.”

Dr. Farber advised, “The trial definitely showed that both surgical and endovascular therapies are effective and important.” He added that they are not one-size-fits-all therapies and that neither approach is good in all cases. He observed, “We have two complementary arrows in our quiver that can be selected at different times for different patients.”

The trial investigators advised that the Novo Nordisk Foundation is contributing a grant to enable researchers to extend and amplify the trial’s impact, including a more detailed analysis of the data, reported SVS in the press release.