SPECIAL SESSION UNDERSCORES ‘COMPLEMENTARY’ NATURE OF OPEN AND ENDOVASCULAR STRATEGIES IN CLTI PATIENTS

A dedicated session yesterday afternoon saw speakers and delegates gather to debate, analyse and consider the implementation of the BEST-CLI and BASIL-2 randomizedcontrolled 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.

By Jocelyn Hudson

irst 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,” continued from page 1

Some of that rancor seen in the aftermath of the release of their findings late last year emerged back then over trial design too. But eventually, the specialties united, and they got NIH grant approval.

They had many difficulties along the way. “This trial was extremely difficult to enroll,” said Farber. “There were multiple curveballs.” The Katsanos meta-analysis. COVID-19. Running out of money.

Upon receiving positive feedback from within the vascular surgery ranks, Farber related, they began the National Institutes of Health (NIH) application portion of their journey.

At first blush, as they prepared to go down the NIH route, they thought vascular surgeons should do the trial owing to the fact they carry out both procedural modalities.

Despite their arguments, the application failed. Yet, they persevered. They responded to the criticisms. Other specialties were included. More funding was secured.

They got there, presenting at the American Heart Association and publishing the results in the New England Journal of Medicine. “We hope our story encourages others to pursue their research ambitions, even in the face of 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 BESTCLI 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.” obstacles, self-doubt and judgment of others,” said Farber.

Menard paid tribute to the man for whom the new VAM lecture is named: Frank Veith, MD. “It is impossible to [over]estimate how much of a maverick Frank has been, and the enormity of what he has contributed to the field,” he said. Menard sees a kindred spirit in Veith in the sense of how the limb-salvage pioneer looks at the foot. Menard, too, likes to try the less conventional. “But one thing I haven’t done, and Frank did it a long time ago: he did a prosthetic bypass to the foot,” said Menard. “It worked. Here’s another thing that Frank did: 13 prior failed procedures—he did a bypass from the common iliac artery to the peroneal artery. And it worked.”

Veith was also an endovascular believer before most had cottoned on to its potential, he said. Menard’s point was centered on progress in CLTI made over the decades. That extends to turf battles—endo vs. open. “Hopefully, never more,” he said. “Turf battles in the vascular community have been, and still are distracting, destructive, highly counter-productive and of very little service to our patients. I charge the audience to sincerely bring to their part to fight an entirely new battle: that is to move beyond this 25-year-old paradigm of endo vs. open.”