BEST-CLI Results Reported at American Heart Association Scientific Sessions

CHICAGO, (Nov. 7, 2022) – For patients at risk for amputation because of severe peripheral artery disease (PAD) – who have a good single segment great saphenous vein and are deemed to be equal candidates for open surgery and endovascular revascularization – surgery was a better treatment option than endovascular therapy.

The results come from a landmark clinical trial that compared two standard treatments for restoring blood flow to the leg: surgery with the patient’s own single-segment great saphenous vein (SSGSV) or with artificial grafts or another vein, versus endovascular therapy such as angioplasty, with or without stenting.

The three principal investigators of the Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia trial (BEST-CLI) – Drs. Alik Farber, Matthew Menard and Kenneth Rosenfield – announced results of the trial Monday at the American Heart Association’s Scientific Sessions. Farber and Menard are vascular surgeons and Rosenfield is a cardiologist with a subspecialty in interventional cardiology. The findings are also being published in the New England Journal of Medicine.

The interventions, either bypass surgery or endovascular therapy, are performed on patients who suffer from PAD, a condition that occurs when peripheral arteries become clogged with plaque. This plaque, “made up mostly of fat and cholesterol … narrows the passageway with the arteries and causes them to become stiff,” according to the Society for Vascular Surgery. Vascular surgeons treat vascular diseases, including PAD and chronic limb-threatening ischemia, (CLTI), which can result from PAD. When PAD becomes severe, patients experience pain at rest and may develop sores on the feet, a sign that amputation might be required.

Estimates on the number of people in the United States with PAD vary widely but are likely as high as 10 million. More than 10 percent of those suffer from chronic limb-threatening ischemia (CLTI), the most severe form of PAD, which carries the risk of amputation, lower quality of life and increased mortality. Globally, an estimated 200 million suffer from PAD and CLTI affects approximately 22 million.

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 great saphenous vein, 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 alternative autogenous vein or a prosthetic would be used (396 patients)

Patients were then randomized one-to-one 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 left up to the clinician.

In the group that included patients who underwent bypass surgery with a SSGSV, there was a 32 percent overall reduction in major adverse limb events or death, based on a 65 percent reduction in major re-interventions, and a 27 percent reduction in above-ankle amputation, said Farber, calling these “statistically significant” findings.

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.

The international research study, funded by the National Heart, Lung and Blood Institute at the National Institutes of Health, 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.”

“To date, the implications of beginning treatment for CLTI with a surgical bypass vs endovascular therapy has been unclear,” said Menard. “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.”

The study found, said Rosenfield, that it’s important that patients have an appropriate initial assessment of their vein status, and for those with a good saphenous vein, bypass surgery “should be considered as the first approach.”

“An important finding was that mortality rates and major cardiovascular safety events were low and equal between the two study groups,” said Menard. “These patients are very ill, but BEST-CLI clearly showed they can undergo surgery with relatively low morbidity and mortality.”  

Rosenfield that noted that “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.” 

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

Menard said, “From a global perspective this is an important landmark trial.” 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.”

The trial investigators have just received word that the Novo Nordisk Foundation is contributing a grant to enable researchers to extend and amplify the trial’s impact, including more detailed analysis of the data.

Alik Farber is with Boston Medical Center, Matthew Menard is with Brigham and Women’s Hospital in Boston, and Kenneth Rosenfield is with Massachusetts General Hospital. Both Farber and Menard are members of the Society for Vascular Surgery. All three investigators wish to thank the Society of Vascular Surgery, which contributed vital financial support to assist with trial follow-up, as well as each of the regional and national vascular surgical, interventional radiology, and vascular medicine societies, VIVA, and industry sponsors who also contributed to the successful effort to extend follow up.

About the Society for Vascular Surgery

The Society for Vascular Surgery is the leading not-for-profit, professional medical society on establishing causes and treatments for vascular disease. SVS seeks to advance excellence and innovation in vascular health through education, advocacy, research and public awareness and is composed of specialty-trained vascular surgeons who are dedicated to providing comprehensive care for vascular disease. For more information visit www.vascular.org. Follow the SVS on Facebook @VascularHealth, Twitter @VascularSVS and Instagram @societyforvascularsurgery.