Feature
How will the BEST-CLI trial impact your practice?
T
he results of the BEST-CLI trial, which were published in the New England Journal of Medicine, yielded
surprising results regarding the role of endovascular therapy in the treatment of critical limb ischemia. The data presents a significant difference between endovascular therapy and traditional bypass surgery with respect to major adverse limb events or reintervention.
On Dec. 6, SIR hosted a members-only town hall to discuss the trial, review the data and consider how the results will impact IR practices.
What is BEST-CLI? Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia, or BEST-CLI, is an international prospective, randomized research study aimed at determining the best revascularization treatment for patients with critical limb ischemia. The study was funded by the National Institutes of Health and is a follow-up to the BASIL study which was published over 15 years ago in The Lancet. BASIL randomized patients for bypass or endovascular surgery, and after 2 years follow-up found no difference in the endpoints of overall survival or amputation free survival.
Unlike BASIL, BEST-CLI researchers judged their primary outcome by the incidence of major adverse limb event (MALE) or death of any cause, and their secondary outcome was major limb events or post-operative death within 30 days, as well as minor interventions.
Over 5 years, 1,830 patients at 150 sites were enrolled and divided into two cohorts. Patients with a single segment of greater saphenous vein (SSGSV) as a potential conduit were enrolled into cohort 1. Those without a SSGSV were enrolled into cohort 2.
12 IRQ | WINTER 2023
Results According to Robert A. Lookstein, MD, FSIR, who presented during the town hall, the BEST-CLI authors reported that among patients who had adequate SSGSV for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among patients who lacked an adequate SSGSV conduit (cohort 2), the outcomes in the two groups were similar.
Within cohort 1, the rate of major adverse limb events or death was 42.6% in patients who received bypass, compared to 57.4% in patients who underwent endovascular therapy. Of those who received surgery, 9.2% had reintervention compared to 23.5% of endovascular patients. Of note, the acute technical success rates of the revascularization procedures were discordant—98.3% of the surgical procedures were successful, whereas only 84.7% of the endovascular reinterventions were successful.
“If you look at the curves for outcomes, the only real difference between bypass and endovascular surgery is in the early reintervention rates,” said Sanjay Misra, MD, FSIR, who was a site investigator for BEST-CLI. “If this study were set up like BASIL and looked primarily at major amputation, the BEST-CLI results would show equivalent outcomes.”
According to Drs. Misra and Lookstein, the technical failure rates are evident within the first 90 days of data, which show high early major reintervention rates for endovascular therapy.
“Every one of us knows when we’re going to fail or have a reintervention. We can tell on our table, and for most of us, we will then reattempt, or follow the patient,” Dr. Misra said. “I believe that a better-balanced assessment would be to look at successful endovascular outcomes and compare them to the successful surgical outcomes.”
Technical success rate The technical success rate of 84.7% is surprising, but the parameters defining failure are key, Dr. Lookstein says. For the surgery group, occlusion of the bypass graft or failure to achieve a patent bypass graft at the completion of the procedure constituted a technical failure. For endovascular surgery, a failure was determined by inability to cross a stenosis or occlusion, or a residual obstruction of more than 50% in the superficial femoral artery, popliteal or all tibial arteries, such that there was no in-line flow to the foot.
Panelists agreed that the low success rate doesn’t seem accurate. Dr. Misra pulled three papers from the previous decade’s endovascular literature that showed technical success rates as high as 89–93%.
“I feel that anything below a 95% success rate is unacceptable,” said panelist Kumar Madassery, MD. “Whatever vascular practice you’re in, that success rate isn’t good.”
Dr. Lookstein also pointed out the breakdown of who performed these procedures.
“Almost the entire investigator list for cohort 1 were vascular surgeons,” he
“I feel that anything below a 95% success rate is unacceptable. Whatever vascular practice you’re in, that success rate isn’t good.” —KUMAR MADASSERY, MD
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