ST. LOUIS - On average, one American dies from stroke every four minutes according to the U.S. Centers for Disease Control and Prevention, and it’s the leading cause of serious long-term disability.
Physicians at Mercy Hospital St. Louis are working to reduce those numbers in many ways. The most recent is by offering patients a clinical trial designed to compare three different methods of stroke prevention to find the safest and most effective treatment for patients with carotid artery narrowing. The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Study (CREST-2), is supported by the National Institute of Neurological Disorders and Stroke of the National Institute of Health.
As the trial is just launching, Mercy is one of the first 11 centers (with a goal of 120) participating in the study that is seeking 2,480 participants across the United States and Canada over the next five years. To qualify, participants must be at least 35 years old, have a significant narrowing of one carotid artery with at least 70 percent blockage, and have no history of stroke or transient ischemic attack (TIA) within the last six months.
Buildup of atherosclerosis 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 clots or debris from the plaque are dislodged from the carotid artery wall. As this material travels through blood vessels it can interrupt blood flow to the brain resulting in stroke.
“Medicines have advanced dramatically since 1995 when we first looked at surgery versus medical management for these patients,” said Dr. Scott Westfall, Mercy Clinic vascular surgeon and principal investigator for CREST-2 at Mercy. “This study is significant to determine the best approach to care for patients with carotid stenosis and no stroke symptoms.”
CREST-2 will compare include intensive medical management or intensive medical management combined with carotid endarterectomy (en-dar-ter-EK-ta-mee) or carotid stenting. Carotid endarterectomy is an operation in which surgeons clean out and repair a main artery supplying blood to the brain. Carotid stenting is a procedure where a metal device called a stent is placed in a narrowed part of the carotid artery to cover the plaque and hold the vessel open. During the stent procedure, a small umbrella-like instrument called an embolic protection device is placed above the stent to catch any particles that might break away.
There are several risk factors for stroke, including high blood pressure, high cholesterol, diabetes, tobacco use, excess body weight, and physical inactivity. These risk factors can be modified through intensive medical management and lifestyle modification. In CREST-2, this stroke prevention method includes using aspirin to prevent blood clot formation, drugs to reduce blood pressure and bad cholesterol (LDL cholesterol), and a personal risk-modification coach to review ways to quit tobacco, manage weight and increase physical activity.
The carotid surgery and carotid stenting procedures in CREST-2 will only be performed by doctors who have demonstrated safety and expertise in the procedures. Of the study participants assigned to carotid revascularization, about half will receive carotid endarterectomy and about half will receive a carotid stent. All participants will receive intensive medical management.
Dr. Westfall heads the team at the Mercy. Mercy Clinic vascular surgeons Drs. Vito Mantese and Richard Pennell are also approved surgeons for the trial. Other doctors involved on the medical management team include Mercy Clinic Drs. William Logan, neurologist; Timothy Schloss, internventional cardiologist; David Rempe, neurologist; and neurology nurse practitioner Marnie Donohoo.
Over the past 20 years, medical management of stroke risk factors has improved such that risk of stroke from asymptomatic carotid stenosis has been significantly reduced. Carotid endarterectomy and carotid stenting (both revascularization procedures) have also improved. There have been no recent studies conducted comparing current medical and interventional treatments of this condition.
For questions about the study or to see if you qualify, please call Mercy Hospital St. Louis Research Institute at 314-251-7899.