said. “IRs made up a very small number of the investigators.”
Panelist Bret N. Wiechmann, MD, FSIR, agreed. “There is an high crossover rate within the first 90 days. How many IRs wouldn’t give it another shot if we fail the first time?”
The endovascular data shows contemporary, advanced technologies and techniques largely weren’t used— most patients were treated with plain angioplasty alone. Drug coated balloons and stents were rarely used and there were low rates of atherectomy or alternate access—Dr. Misra points out that the technical failure rate is closer to data from almost 20 years ago.
“A success rate of 84.7% is not what we would expect, and it raises a lot of questions,” he said. “What was the TASC classification on the failures? Were there reattempts on the table?”
The lack of TransAtlantic InterSociety Consensus (TASC) classification data makes it difficult to understand the factors that led to the high technical failure rate, Dr. Misra said. Referring back to the earlier papers he pulled, all listed procedural details, including TASC classification.
Missingness The TASC classification is among several other points of data that haven’t been released from BEST-CLI, which have contributed to a higher rate of missingness than peer NIH studies such as ATTRACT (10.5%), CORAL (11.2%) or CLEVER (8.3%).
“Doing research in the United States today is very hard,” Dr. Misra said, noting the hard work and skill of the lead researchers and all investigators. “But this is a high rate of missingness—one you could accept for retrospective, but not at this level.”
Dr. Misra urged IRs to compare the BEST-CLI rates to their own data—if IRs have access to it.
“How many of us know our own data and outcomes? How many of us are keeping logs?” he asked. “We have to support our own data sets, to show that an 85% success rate is not good enough and not accurate. We have to support our own registries, like VIRTEX.”
Patient demographics Drs. Lookstein and Misra agree that IRs should look closely at the BEST-CLI patient demographics and exclusion requirements to see how generalizable the results are.
“When you look at the cohort breakdowns, you see that only 28% are women, 20% are Black, 13% are Hispanic and only 10% have renal insufficiency or renal failure,” Dr. Lookstein said. “You have to wonder, how applicable is this to the general population, and to my patients specifically?”
Dr. Lookstein focused on the analysis and confidence interval data within the trial, which indicated no benefit of bypass over endovascular surgery for Black patients, patients over the age of 80, or those with existing renal dysfunction—which, as many of the town hall panelists pointed out, are key demographics which many IRs serve for CLI treatment.
“Remember that patients in the trial had to have a good vein and be a good surgical candidate,” Dr. Misra said. “Those are fairly restrictive inclusion criteria.”
According to Srini Tummala, MD, FSIR, most of the patients he sees in South Florida would not qualify for BEST-CLI due to having had a coronary artery bypass graft, or just not having a suitable vein.
Parag Patel, MD, FSIR, who also served as a site investigator for BEST- CLI, agreed. “The cohorts don’t fully
represent the patients we usually see,” he said. “Our patients have high rates of diabetes and chronic kidney disease.”
Overall impact Though the study has raised multiple questions, the largest is “What impact will the data have on IR practices, referral patterns and relationships with vascular surgeons?” According to Mary Constantino, MD, FSIR, a panelist at the town hall, it likely won’t impact her own referrals or patient selection.
“I work closely with the vascular surgeons in town,” she said. “In my practice, I’ve started to do vein mapping on everyone and for patients with good veins, high platelets and small vessels, I send them directly to surgeons first.”
Dr. Lookstein also doesn’t expect to see changes at his institution.
“We have had meetings and spoken openly with our vascular surgeon colleagues, whose endovascular success rate is higher than this trial,” he said. “We agree that you need to look for the best revascularization specialists— not just vascular surgeons. If you’re an endovascular expert with a 95% technical success rate, you will have excellent outcomes for your patients. So IR and our vascular surgery group have reached the consensus that this trial should not apply broadly to the entire US population suffering from CLI.”
What comes next There’s still data to unpack, such as the BEST-CLI registry, which has not released results yet. Without that and other data, Dr. Misra says, it’s hard to plan another study or think about what to question next.
However, all panelists agreed: more data, delivered by IRs, is needed.
“We need to make sure the best data gets out there, and if we don’t do it ourselves, we’ll have to rely on trials like this,” Dr. Lookstein said. “If IRs want better data, we need to get involved in prospective research and produce it ourselves.”
Learn more about BEST-CLI and watch the town hall here.
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bit.ly/3iFbWtp)
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