CREST Trial to Study Treatment for Carotid Artery Disease Expanded to Include Asymptomatic Participants, Additional Sites.

NEWARK, N.J. -- Positive Preliminary Data Presented at International Stroke Conference

The University of Medicine and Dentistry of New Jersey (UMDNJ) today announced an expansion in scope of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) study to include asymptomatic participants, and the addition of participating trial sites from 70 to 110.

Sponsored by the National Institute of Neurological Disorders and Stroke and the National Institutes of Health, CREST is a randomized clinical trial to evaluate - in patients who are at normal risk for surgery - the efficacy of carotid artery stenting as compared to carotid endarterectomy (carotid surgery) in preventing stroke, myocardial infarction and death in the 30-day period immediately following the procedures, and ipsilateral stroke (occurring on the same side of the brain in which the stent was placed) during a multi-year follow-up period. More than 1,000 participants have been enrolled in the lead-in phase, and more than 400 participants have been enrolled in the randomized phase of the trial.

"We are pleased that CREST will now include asymptomatic subjects who are at normal surgical risk for carotid endarterectomy in this important study," said Robert Hobson, II, M.D., the principal investigator for the trial. "Broadening the scope of CREST to include asymptomatic patients - and expanding the trial to 110 sites - will benefit more patients, enhance clinical understanding and allow us to better gauge the safety and effectiveness of carotid stenting versus surgery in the broad-base population currently receiving surgical treatment."

More than two-thirds of the carotid endarterectomies performed in the United States are performed on patients who are asymptomatic. The narrowing of the carotid artery puts them at future risk of stroke from their carotid disease, but they have yet to display neurological symptoms. Previous to January 2005, only participants with symptomatic carotid disease were included in the randomized arm of CREST.

The lead-in (or credentialing) phase of CREST includes both high-surgical-risk and low-surgical-risk patients with carotid stenosis (narrowing of the artery) treated by stenting. Preliminary results - which were discussed at the International Stroke Conference in February - from more than 1,000 participants in this stage of the study show 30-day all-cause stroke and death rates of 3.0 percent and 2.7 percent for symptomatic and asymptomatic subjects less than 80 years of age, respectively. "These data are encouraging, and we appreciated the opportunity of discussing the data at this year's conference in New Orleans," said Thomas Brott, co-principal investigator, CREST.

Treatments for Carotid Artery Disease

Carotid artery disease involves the buildup of plaque in one or both carotid arteries in the neck. The carotid arteries supply vital oxygen and glucose-rich blood to the parts of the brain where thinking, speech, personality, and sensory and motor functions reside. Patients with carotid artery disease have three treatment options: carotid artery stenting - which currently is approved in the United States for high-risk patients only - carotid surgery, known as carotid endarterectomy, or medical therapy.

The traditional surgical treatment for carotid artery disease usually entails general anesthesia and involves an incision in the patient's neck and artery to remove plaque from inside the vessel wall. In contrast, during a carotid stenting procedure, the embolic protection system is positioned in the carotid artery and a stent is deployed using a catheter inserted into a small puncture in the patient's groin. The patient usually remains conscious while the stent is implanted at the site of the blockage. The embolic protection system is designed to capture and remove particles of plaque that might be dislodged during the procedure, which could potentially lead to stroke and other complications.

About Stroke and Carotid Artery Disease

Stroke is the third leading cause of death in the United States and the number one cause of disability in adults, according to the American Heart Association. Up to 25 percent of strokes are caused by carotid artery disease. Clogged carotid arteries can cause ischemic stroke, the most common type. An ischemic stroke can occur when carotid arteries become narrowed and when small particles of atherosclerotic plaque become dislodged from the diseased artery wall. This embolic material can travel through the bloodstream and block vessels in the brain. More than 700,000 Americans will have new (500,000) or recurrent (200,000) strokes each year, and 280,000 will die. The lifetime cost of stroke exceeds $90,000 per patient in the United States.