A dedicated session at VAM 2023 saw speakers and delegates gather to debate, analyse and consider the implementation of the BEST-CLI and BASIL-2 randomized-controlled trials (RCTs). There was general agreement that the strategies are complementary, and that “picking the right thing for the right patient at the right time” should take precedence.
First to speak were Alik Farber, MD, MBA, professor of surgery and radiology at Boston University, and Matthew T. Menard, MD, associate professor of surgery at Brigham and Women’s Hospital in Boston, who shared key findings from the BEST-CLI trial.
They concluded that the BEST-CLI trial “supports a complementary role for open and endovascular revascularization strategies and highlights the need for expertise in both for optimal care of these patients.”
The next step? According to Farber and Menard, this will be to figure out which patients are best treated with surgery and which with endovascular therapy.
The focus then moved to BASIL-2, with Andrew Bradbury, MD, MBA, professor of vascular surgery at the University of Birmingham in Solihull, England, sharing main findings from this trial. He addressed the question, will BASIL-2 change practice in the UK? To this he said that in around 50% of patients it is not “obvious” that infrapopliteal vein bypass or best endovascular therapy is preferable and so there is “no strong [multidisciplinary team meeting] recommendation” on the subject.
Next on the agenda was a debate, during which Michael S. Conte, MD, professor and chief of the division of vascular and endovascular surgery at the University of California San Francisco was tasked with arguing that patients with chronic limb-threatening ischemia (CLTI) who have adequate saphenous vein should be treated with bypass.
Before getting started, he modified the debate question to read: “Patients with CLTI who are acceptable surgical candidates, and who have adequate great saphenous vein, should be offered bypass surgery as an initial treatment strategy.” His closing message was in line with that posed before him, that endovascular and open are complementary therapies. “It’s time for our field to mature and develop an evidence-based framework akin to [coronary artery disease],” he stressed, urging delegates to “stop the simple-minded ‘open vs. endo’ debate.” The important thing is “picking the right thing for the right patient at the right time,” he said.
Delivering the counterview, Brian G. DeRubertis, MD, of Weill Cornell Medicine in New York, contended that “almost all” patients with CLTI who have adequate saphenous vein should be treated with bypass. He argued that this was an “easier stance” as—he put forward—an endovascular-first treatment strategy “has become the standard of care for the majority of patients with CLTI over the last 15 years.” He underlined the fact that recent randomized controlled trials “demonstrate an important and preferred role for surgical bypass in some patients with CLTI,” noting however that trial results “do not suggest this is true for most patients.”
“We have yet to determine exactly which patients warrant a bypass-first approach.”
Following the debate, Vincent L. Rowe, MD, professor of clinical surgery at the University of Southern California Los Angeles, spoke on “how best to capture meaning” from the two trials.
One of the points Rowe made in his conclusion was that the death rates in both trials were “very high” and that a deeper dive on what was causing these deaths is warranted. “Is there some type of risk factor that we can find that’s causing all of these deaths to occur in these patients?”
Addressing the question “what is BEST for CLTI?” Misty D. Humphries, MD, MS, associated professor of surgery at the University of California-Davis in Sacramento, weighed up the pros and cons of both an administrative database and a randomized trial. Concluding, she argued that observational studies are “not going anywhere,” but stressed that there “may be saturation without changes in data fields.” Randomized trials, on the other hand, cost “lots of money, but eliminate bias.” Alongside these concluding thoughts, Humphries included a picture on the slide, highlighting a question that was in keeping with one of the overarching themes of the session: “Can’t we all just get along?”
Finally, Kristina A. Giles, MD, division chief of the department of surgery at Main Medical Center in Scarborough, Maine, addressed the topic of implementing BEST-CLI and BASIL-2, sharing “what will be easy and what will not.”
Scrutinizing the data, realizing that the trials are complementary, and realizing that open and endovascular methods are complementary will be “easy,” she said, while noting that one of the harder aspects of implementation will include the challenges associated with vein mapping everyone before an angiogram, among others.
Moderator Joseph L. Mills Sr., MD, of the Baylor College of Medicine in Houston, opened the discussion with a question on bias. Conte remarked here that “bias comes in lots of forms” and brought up a “major bias” in real-world practice that is the economic and workflow bias. “A lot of people are working in places where doing surgery is inconvenient for their workflow and potentially forgotten.”
Various panel and audience members brought up coronary disease in CLTI patients. Touching on a point he made during his presentation, Rowe averred that “death was most likely caused by a coronary event,” with Mills also stating that “we need to pay more attention to coronary disease.”
In this vein, Menard commented that one of the tasks ahead for the trial investigators is to look at both trials closely, stressing that “shockingly, we don’t know what our patients are dying from, that’s step one.” complementary
