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Rates of death, stroke after CAS low in CREST-2 registry
Rates of periprocedural death and stroke were low in patients from the CREST-2 registry who underwent carotid artery stenting, researchers reported in the Journal of the American College of Cardiology.
The CREST-2 registry is a companion to the ongoing CREST-2 trial, which is comparing CAS and carotid endarterectomy against intensive medical management in patients with carotid stenosis. Because reimbursement issues caused U.S. CAS procedures to decline, the registry was established “to provide the means to maintain, enhance and ensure requisite expertise in CAS in order to conduct a rigorous randomized controlled clinical trial comparing CAS to intensive medical management alone,” Brajesh K. Lal, MD, associate professor of surgery and director of endovascular surgery at the University of Maryland Medical System, and colleagues wrote.
Patients in the registry were not included in the randomized trial because they did not qualify or because they declined to participate, according to the researchers.
Low death, stroke rates
Among the cohort of 2,141 patients who underwent CAS, 78 of whom had a bilateral procedure, the rate of stroke or death at 30 days was 2% (stroke, 1.6%; death, 0.4%), according to the researchers. In those with asymptomatic carotid stenosis, the rate was 1.4% (stroke, 1%; death, 0.3%), while for those with symptoms, the rate was 2.8% (stroke, 2.4%; death, 0.4%), Lal and colleagues wrote.
The procedures were performed by 187 operators from 98 sites. In the patient population, the mean age was 68 years, 65% were men, 92% were white and 55% were asymptomatic.
All FDA-approved carotid stents and embolic protection devices were used, according to the researchers.
“CAS was performed by experienced operators using appropriate patient selection and optimal technique,” Lal and colleagues wrote. “In that setting, a broad group of interventionists achieved very low periprocedural stroke/death rates for asymptomatic and symptomatic patients.”
Adjudication questions
The findings represent “the lowest 30-day stroke or death rates that have ever been reported in the carotid stenting published research,” Cardiology Today Next Gen Innovator Jay Giri, MD, MPH, FAHA, director of peripheral intervention at the Hospital of the University of Pennsylvania and assistant professor of medicine at the Perelman School of Medicine at the University of Pennsylvania, and Jeffrey W. Olin, DO, professor of medicine at the Icahn School of Medicine at Mount Sinai, wrote in a related editorial.
However, they wrote, that could be a matter of adjudication.
“Although it is clear that the quality assurance program went beyond what is typically instituted in registries ... it is still likely that at least some component of the low stroke and death rate is due to the fact that small, nondebilitating strokes were missed without independent adjudication by a stroke neurologist,” Giri and Olin wrote. “Additionally, patients were assessed only at baseline and 30 days. It is surprising that the stroke rate in a true all-comers population could really be half of that seen in patients more carefully selected for a randomized trial.” – by Erik Swain
Disclosures: The registry is funded by the NIH’s National Institute of Neurological Disorders and Stroke, Abbott Vascular, Boston Scientific, Cordis/Cardinal Health, Medtronic, Silk Road Medical and W.L. Gore and Associates. Lal and Olin report no relevant financial disclosures. Giri reports he has served on advisory boards for AstraZeneca and Phillips Medical Systems and has received institutional research support from Recor Medical and St. Jude Medical. Please see the study for all other authors’ relevant financial disclosures.