BEST-CLI trial raises further questions over open or endovascular approach in CLTI patients

Results from the largest randomised trial comparing revascularisation strategies in patients with chronic limb-threatening ischaemia (CLTI) have ignited debate over which patients are suitable for either an open surgical or endovascular approach.

THE RESULTS FROM BEST-CLI, A MAJOR multidisciplinary trial involving investigators from the fields of vascular surgery, interventional cardiology, interventional radiology and vascular medicine, were delivered at the American Heart Association (AHA) scientific sessions (5–7 November, Chicago, USA) and published simultaneously in the New England Journal of Medicine.

Results of the trial showed that among a population of 1,830 CLTI patients deemed suitable either for an open or endovascular procedure, surgical bypass with adequate single-segment great saphenous vein (GSV) is a more effective approach. Both strategies, however, were shown to be safe and effective when it came to treating CLTI.

BEST-CLI co-principal investigators—Alik Farber (Boston Medical Center, Boston, USA), Matthew Menard (Brigham and Women’s Hospital, Boston, USA), and Kenneth Rosenfield (Massachusetts General Hospital, Boston, USA)—acknowledge that the findings will provide important information regarding their management.

But, recent discussions of the trial’s results suggest that there is still some way to go to settle the question of which strategy should be favoured in patients suitable for either approach. This was brought to the fore in a standalone BEST-CLI session at the recent 2022 VEITHsymposium (15–19 November, New York, USA), which saw commentary being led by interventional cardiologist Eric Secemsky (Beth Israel Deaconess Medical Center, Boston, USA), representing a perspective from the endovascular community, and Michael Conte (University of California, San Francisco, San Francisco, USA), providing a view from the vascular surgery sphere.

Secemsky said BEST-CLI provided robust critical evidence but bore limitations in terms of the inclusion of major reintervention in the primary endpoint, the representativeness of non-surgical specialties in the trial, as well as the “generalisability” of the patients enrolled. “Patient preference, surgical candidacy, prognosis, suitable anatomy, technical proficiency, costs and timely access to care remain important considerations when deciding whether to pursue a surgical versus endovascular strategy,” he pointed out. Conte said the trial showed that open surgery and endovascular intervention “are both safe and have were no major amputations, no major reinterventions, and complete freedom from perioperative death, “so it was a safe device,” Varcoe reported. complementary roles in the treatment of CLTI patients.” He said that open bypass with GSV provides more effective revascularisation in suitable candidates, and “is likely under-utilised in current practice,” adding that “an endo-first or endo-only approach to all patients with CLTI is not evidence-based care.” Centres carrying out less than 20% bypass in CLTI “should probably take stock,” he commented.

The team also saw a rate of allcause death of 0%, target lesion amputations were 0%, and a “very low” rate of clinically driven target lesion revascularisation at 8%. The late lumen loss of 1mm at six months compares “very favourably” to equivalent DCB trials below the knee, Varcoe said.

At six months, the researchers observed a primary patency of 88.5%. Varcoe noted that this was consistently retained out to 12 months at 80%— which is “very good for this part of the vasculature”. Varcoe then added that, regarding quality of life, patientreported outcome measures were also consistently improved to 12 months.

In closing, Varcoe shared his belief that the Sundance device has “great promise” and “warrants evaluation in a large-scale pivotal trial” based on these findings.

During the session, Farber delved into potential trial weaknesses. It was a pragmatically designed trial, with the possibility for selection and operator bias in enrolment and intervention, he noted. Farber also acknowledged the trial’s cohort 2—comprising patients who did not have adequate saphenous vein— as likely underpowered.

Rosenfield, meanwhile, noted the “controversy” the trial will generate: “[Amongst the BEST-CLI investigators] we have differences in the way we think it should be interpreted. My perspective is a little bit more muted than sort of the ‘Okay, this just tells the whole story about how you have to treat CLTI patients.’” His “top line,” he said, is that bypass fundamentally bears an important role in the treatment of CLTI, underscoring how the trial also showed that both procedures are safe. The lesser-discussed cohort 2, Rosenfield said, gets to one of his points of focus—that the study “raises a lot of questions that still need to be answered.”