Clinical trial comparing treatments for carotid artery disease recruits over 1100 patients, seeks more minorities and women

Friday, June 30, 2006

JACKSONVILLE, Fla. — Researchers have enrolled over 1000 people at risk for stroke from carotid artery disease in an ongoing, nationwide clinical trial comparing two procedures used to prevent stroke. Researchers with the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), still hope to recruit more women and minorities in order to reach their goal of 2,500 randomized participants. Of those 2,500 participants, CREST hopes to achieve 40 percent women and 12 percent minority enrollment.

Mayo Clinic in Jacksonville is one of more than 90 medical centers approved to participate in the study. Dr. Thomas Brott, a neurologist at Mayo Clinic, is the CREST national co-principal investigator. He stresses the importance of minority participation. "All patients deserve the best care, regardless of race or gender, he says. " But for minority patients, our studies cannot select out the best new treatments unless minorities are represented in the studies in large numbers."

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 four-year 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.

Jacqueline Light was at work one day in October 2004 when she had a stroke. "I knew something was wrong with my body. I wasn't seeing clearly," she says. The Jacksonville woman was inclined to wait to see if her vision would get better. Fortunately, Light's coworkers convinced her to get medical treatment. At Mayo Clinic's St. Luke's Hospital, Light was randomized to receive carotid artery stenting for blockage in her left carotid artery. "I was very happy to be accepted into the trial," she says. Subsequently, Light also underwent a carotid endarterectomy on the right carotid artery to remove blockage on that side. She found the stent to be "much easier." The carotid endarterectomy is effective and durable. Stenting can be done safely and is less invasive. The goal of CREST is to determine which of the two approaches is best in preventing stroke.

Buildup of arteriosclerosis, or plaque, commonly known as hardening of the arteries, occurs at the point where the carotid artery divides into the internal and external arteries. Patients with carotid artery disease may be at risk for stroke if particles of atherosclerotic plaque are dislodged from the carotid artery wall. As these particles travel through the blood stream they can block the vessels in the brain, preventing adequate blood flow and causing the condition known as stroke.

Endarterectomy is the traditional surgical treatment for carotid artery disease. It has been performed since the 1950s in patients with or without symptoms of stroke or impending stroke. The procedure 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, a clot capture 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 clot capture 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.

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

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