CREST trial to study treatment for carotid artery disease expanded

Friday, June 10, 2005

JACKSONVILLE, Fla., June 10, 2005 — The University of Medicine and Dentistry of New Jersey recently announced an expansion of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST). Participants who have no symptoms of carotid artery disease may now be enrolled, and 40 participating trial sites will be added.

Mayo Clinic in Jacksonville is one of the medical centers participating in the study that is seeking 2,500 participants across the United States and Canada. Mayo will be enrolling qualified participants over the next three to four years according to Dr. Thomas Brott, a neurologist at Mayo Clinic and CREST national co-principal investigator.

Sponsored by the National Institutes of Health, CREST is a randomized clinical trial to compare a minimally invasive procedure called carotid artery stenting with the surgical procedure called carotid endarterectomy in patients who are at normal risk for surgery.

The trial compares the effectiveness of both procedures in preventing stroke, heart attack and death during the 30-day period immediately following either procedure. Over a multiyear follow-up of patients who receive the stenting procedure, the trial will also document the incidence of stroke occurring on the same side of the brain in which the stent was placed.

"Broadening the scope of CREST to include asymptomatic patients, who are at normal surgical risk for carotid endarterectomy, 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," said Brott.

More than two-thirds of the carotid endarterectomies performed in the United States are performed on patients who have no symptoms. 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. Before January 2005, only participants with symptomatic carotid disease were included in the randomized arm of CREST.

Preliminary results from more than 1,000 participants in the first stage of the study show death or stroke from any cause during the 30-day period following the stenting procedure was 3 percent for asymptomatic patients less than 80 years old and 2.7 percent for symptomatic patients less than 80 years old. "These data are encouraging," said Brott. "And they compare favorably with morbidity and mortality rates associated with endarterectomy."

Within the study, half the patients will receive a carotid stent and half will have carotid endarterectomy. Guidant Corporation is providing both investigational devices (the ACCULINK™ Carotid Stent System and the ACCUNET™ Embolic Protection System) being used in CREST.

Participants in the trial will also receive the best-known medical management to reduce their risk factors for stroke. These include: high blood pressure; obesity; diabetes; smoking; and a high-fat, high-cholesterol diet.

Dr. Albert Hakaim, a vascular surgeon and CREST principal investigator at Mayo, Dr. W. Andrew Oldenburg or Dr. Robert Wharen will perform the endarterectomies. Dr. David Miller, an interventional neuroradiologist at Mayo, heads the team that will perform the carotid artery stenting procedures. Mayo Clinic neurologists Dr. Frank Rubino, Dr. James Meschia and Dr. Benjamin Eidelman are also participating in CREST.

Those interested in participating may call (904) 953-2854.

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-surgical-risk patients only; carotid surgery, known as carotid endarterectomy; or medical therapy.

Since the late 1950s, endarterectomy has been performed in patients with or without symptoms of stroke or impending stroke. According to the American Heart Association and the American Stroke Association, approximately 140,000 of these surgical procedures are performed each year.

However, the operation carries some risks, and many physicians have questioned whether it is better than less invasive carotid stenting for the same conditions. "If your doctor finds a blockage in your carotid artery, are your chances of avoiding a stroke better if you have a carotid stent?" asks Dr. Robert Hobson, II, the principal investigator for this North American study.

Hobson is a professor of surgery and the director of the Division of Vascular Surgery at the University of Medicine and Dentistry of New Jersey Medical School. Results from CREST may be able to answer this and other important questions regarding the treatment of carotid disease.

The traditional surgical treatment for carotid artery disease usually involves general anesthesia before an incision in the patient's neck and artery to remove plaque from inside the vessel wall. In contrast, during a carotid stenting procedure, an 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 15 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.

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Mayo Clinic is a multispecialty medical clinic in Jacksonville, Fla. The staff includes 313 physicians working in more than 40 specialties to provide diagnosis, treatment and surgery. Patients who need hospitalization are admitted to nearby St. Luke's Hospital, a 289-bed Mayo facility. Mayo Clinics also are located in Rochester, Minn., and Arizona. Visit www.MayoClinic.org/news for all the news from Mayo Clinic.

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