Carotid endarterectomy and carotid stenting produced broadly similar results in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), the largest comparison yet of the two procedures. The results were presented in San Antonio this morning at the American Stroke Association’s International Stroke Conference 2010.
CREST, which was funded by NINDS and Abbott, randomized 2,502 symptomatic and asymptomatic patients with carotid stenosis at 117 centers in the US and Canada. The primary endpoint was the 30 day rate of stroke, death, and MI combined with the rate of ipsilateral stroke over the next 4 years. There was no significant difference between the two procedures (7.2% for stenting versus 6.8% for surgery) at a median followup of 2.5 years.
The rate of events at 30 days was 5.2% in the stent group versus 4.5% in the surgery group. The rate of stroke was slightly higher in the stenting group (4.1% versus 2.3%), but the MI rate was slightly higher in the surgery group (2.3% versus 1.1%). One pattern that emerged, somewhat counterintuitively, was that patients older than 70 derived more benefit from surgery, while younger patients did better with stenting.
At a news conference, trial investigator Wayne Clark discussed the difference between the CREST results and the ICSS results published the night before in the Lancet, which found a clear benefit for surgery over stenting. Clark pointed out that CREST had a very long lead-in period during which the operators were required to perform many procedures. “These were very experienced operators,” he said. He also noted that everyone in CREST used the same stent and protection device.
Asked about the utility of MRI scans to objectively assess outcome and avoid ascertainment bias, as in the ICSS MRI substudy, Thomas Brott, lead author of CREST, said that he was not a big fan of the scans. “We treat the patients, not the scans,” he said.
“For the present, stenting offers a reasonable alternative to carotid artery surgery,” Brott said in an AHA press release. “For younger patients, carotid stenting appears to be a very useful tool.”
Here is the AHA press release:
Surgery, stenting to open blocked neck arteries similar in safety, efficacy, but show differences in stroke, heart attack and death rates at certain ages
- Two ways to open narrowed neck arteries — surgery or stenting — proved similarly safe and effective overall.
- Younger patients had fewer cardiovascular events with an implanted stent, while older patients had fewer events with the surgical option.
- Stroke and death rates in the study were the lowest ever reported in a clinical trial, researchers said.
American Stroke Association late-breaking science report:
SAN ANTONIO, Feb. 26, 2010 — The two major procedures for opening blocked neck arteries to restore blood flow to the brain 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.
In endarterectomy, a surgeon cuts into the artery and carefully removes the obstructing plaque from the vessel wall. Surgeons have relied on endarterectomy for a half century to open narrowed carotid (neck) arteries. In stenting, which has been used for about 15 years, a balloon catheter is inserted into the artery to open it, and a metal mesh tube is left in place to keep the vessel open.
“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, M.D., lead author of the study and professor of neurology and director for research at the Mayo Clinic campus in Jacksonville, Fla. “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 percent in the surgical patients and 4.1 percent in the stenting group. However, the heart attack rate was higher in the surgical group, 2.3 percent, compared to 1.1 percent 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 percent were female and 9 percent minorities — to receive either endarterectomy or stenting at more than 100 North American hospitals. More than 80 percent of the participants had an artery blockage greater than 70 percent.
“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, M.D., Ph.D.; George Howard, Dr. Ph.; William Brooks, M.D.; Ariane Mackey, M.D.; L. Nelson Hopkins, M.D.; Alice J. Sheffet, Ph.D.; Virginia J. Howard, Ph.D.; Jenifer H. Voeks, Ph.D.; James F. Meschia, M.D.; Brajesh K. Lal, M.D.; Donald E. Cutlip, M.D.; and Wesley S. Moore, M.D. Author disclosures are on the abstract.
Statements and conclusions of study authors that are presented at American Heart Association/American Stroke Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing science content. Revenues from pharmaceutical and device corporations are available at http://www.americanheart.org/corporatefunding.