We spoke with BEST-CLI trial principal investigators Alik Farber, MD, from Boston Medical Center; Matthew Menard, MD, from Brigham and Women's Hospital; and Ken Rosenfield, MD, from Mass General Hospital during the American Heart Association’s Scientific Sessions 2022 conference in Chicago The trial looked at endovascular versus bypass surgery in patients with critical limb ischemia (CLI) to see which treatment option is better.
While outcomes were similar, and both approaches are safe and effective, the trial showed surgery had an edge with a better outcomes. This was especially true in patients who have vessels that are good for use in a bypass. For those with poor bypass graphs, there was no difference in outcomes between surgery or endovascular revascularization.
BEST-CLI is a landmark trial because it is the first large scale, randomized trial to look at the two therapy approaches in patients with severe peripheral artery disease (PAD). The trial also required vascular surgeons and interventional operators to work together. The result is they are more willing to work as a vascular team to decided what is best for patients, similar to the heart team approach that has developed over the past decade.
"There has been this sort of 'endo-first for everybody' mentality that has taken over, and this proves that is not necessarily the case and surgery may be the better option for some patients," explained Rosenfield, an interventional cardiologist, section head of vascular medicine and intervention, and chairman of STEMI and Acute MI Quality Improvement Committee at Massachusetts General Hospital. "This brings us evidence that we can now discuss with our patients about their options."
The trial evidence also puts to rest some of the pre-conceived ideas that surgery was less safe or that endovascular therapy was better than surgery.
"One of the key takeaways from the trial was that surgery is safe," said Menard, co-director, endovascular surgery, Brigham and Women's, and associate professor at Harvard Medical School. "There was a thought that surgery had a higher mortality and morbidity rate than endovascular care and we did not find that. We found very similar rates of mortality and overall MACE events."
Rosenfield said patients in both groups did well and the quality of life in both arms improved dramatically, so the trial overall showed both therapies to be effective and safe.
"This speaks to the importance of revascularization, getting more blood flow to the foot, regardless of how you do it, it is very important," explained Farber, who is chief of the Division of Vascular and Endovascular Surgery, associate chair for clinical operations and a professor of surgery and radiology at Boston Medical Center.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com