The principal investigators behind the BEST-CLI trial struck a conciliatory tone during the inaugural Frank J. Veith Distinguished Lecture yesterday morning in which they laid bare the blood, sweat and tears shed on their journey to complete the landmark study.
The headline findings that emerged out of the trial—that both open and endovascular procedures were equally safe, and that chronic limb-threatening ischemia (CLTI) patients deemed suitable for either approach who had an adequate great saphenous vein experienced better overall clinical outcomes after open bypass surgery—sparked rancor in the interventional and surgical communities.
Yet, Alik Farber, MD, and Matthew Menard, MD, used the maiden Veith Lecture to shine a light down a path toward further advances in end-stage peripheral arterial disease (PAD) care. The pair used the platform to tell the story of their journey in order that others might take the leap of faith they did to tackle “impactful questions in science,” Farber told VAM 2023 attendees.
They first got together to develop the idea for a trial to compare open vs. endo treatment for CLTI in 2007. “It really was the blind leading the just as blind,” quipped Menard. As Farber described, personally he had very little experience in clinical trials at the time. “There was a lot of insecurity,” he said. “Were we really the right people to do this?” he recalled thinking back then.
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. 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.
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 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.”