CREST Trial Results Announced at 2010 International Stroke Conference
Endarterectomy and Stenting Are Similar in Safety and Efficacy, But Show Differences in Stroke, Heart Attack and Death Rates at Certain Ages
SAN ANTONIO, Feb. 26, 2010 — Carotid endarterectomy and carotid stenting proved similar in overall long-term safety and efficacy, but showed differences in stroke and heart attack in the weeks following the procedure, according to late-breaking science presented at the American Stroke Association’s International Stroke Conference 2010.
The Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), funded by the National Institute of Neurological Disorders and Stroke with supplemental funding by Abbott, is the largest randomized clinical trial comparing the surgical approach (carotid endarterectomy) to the non-surgical approach (carotid stenting) to prevent stroke among patients with and without symptoms.
“We found that the two procedures were similar with regard to the study’s primary endpoint —overall incidence of stroke, heart attack and death,” said Thomas G. Brott, MD, lead author of the study and professor of neurology and director for research at the Mayo Clinic campus in Jacksonville, Florida. “We also found that the rates of these events were low, and that safety for patients with and without symptoms was as good as any reported in any randomized carotid intervention trial.”
Initial findings from CREST came from a median follow-up of about two-and-a-half years. Some patients have been followed for up to a total of four years.
Brott and his colleagues found that in the 30-day period following the procedure, the rate for stroke was 2.3% in the surgical patients and 4.1%t in the stenting group. However, the heart attack rate was higher in the surgical group, 2.3%, compared to 1.1% in the stenting group. The difference in heart attack and stroke between the two groups was statistically significant, Brott said.
The study also found that the age of the patient made a difference in outcome. At approximately age 69 and younger, stenting results were slightly better, with a larger benefit for stenting, the younger the age of the patient. Conversely, for patients older than 70, surgical results were slightly superior to stenting, with larger benefits for surgery, the older the age of the patient.
In other words, younger patients had fewer events with an implanted stent, while older patients had fewer events with the surgical option, the researchers conclude.
CREST researchers enrolled two types of patients with a partial carotid blockage. Symptomatic participants had suffered a non-disabling stroke or a transient ischemic attack (TIA) within the previous six months. Asymptomatic patients had not had a stroke or TIA during the same time span.
Researchers randomized 2,502 patients— 35% were female and 9 percent minorities — to receive either endarterectomy or stenting at more than 100 North American hospitals. More than 80% of the participants had an artery blockage greater than 70%.
“It was not a healthy group with regard to risk for stroke, but we believe the group is very representative of patients with severe carotid artery disease,” Brott said.
In addition, researchers found that symptomatic and asymptomatic patients, and males and females, had similar outcomes in the surgical and stenting groups.
“These were the lowest rates ever reported” in a randomized clinical trial comparing these procedures, Brott said.
CREST patients who suffered a heart attack reported a better quality of life after recovery than patients who suffered a stroke.
Advances in technology in opening clogged carotid arteries have occurred since the procedures began.
“For the present, stenting offers a reasonable alternative to carotid artery surgery,” Brott said. “For younger patients, carotid stenting appears to be a very useful tool.”
Co-authors include: Gary S. Roubin, MD, PhD; George Howard, Dr Ph; William Brooks, MD; Ariane Mackey, MD; L. Nelson Hopkins, MD; Alice J. Sheffet, PhD; Virginia J. Howard, PhD; Jenifer H. Voeks, PhD; James F. Meschia, MD; Brajesh K. Lal, MD; Donald E. Cutlip, MD; and Wesley S. Moore, MD.
For more information about the CREST Trial, go to:
http://clinicaltrials.gov/ct2/show/NCT00004732
