The Cardiovascular Institute of Northwest Florida (CVI) and Bay Medical Center have been selected as a site for a major national study comparing three treatment methods for patients with carotid disease. Only 120 medical centers will be participating in the study which is supported by the National Institute of Neurological Disorders and Stroke of the National Institute of Health.
Buildup of plaque 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 debris from the plaque, or a clot, is dislodged from the carotid artery wall. As this material travels through blood vessels it can interrupt blood flow to the brain resulting in stroke. Stroke is the fifth most common cause of death in the United States and the leading cause of disability in adults.
The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Study (CREST-2) is seeking 2,480 participants in the United States and Canada and will compare intensive medical management to carotid artery stenting and carotid endarterectomy. To date, no research has been conducted to compare the treatment differences between medical management and these two procedures. CREST-2 is intended to compare these treatment options in patients without recent stroke and without stroke warning signs.
Physicians participating in the study include interventional cardiologists Amir Haghighat, M.D. and Samir Patel, M.D.; neurologist Hoda Elzawahry, M.D.; and vascular surgeon Patrick Tamim, M.D.
“Physicians want to identify the best way to prevent strokes in people who have a narrowing in their carotid artery,” says Dr. Haghighat. “CREST-2 is designed to compare three different methods of stroke prevention to find the safest and most effective treatment for patients with carotid artery narrowing.”
To qualify, participants must be at least 35 years old, have a significant narrowing of one carotid artery with at least seventy percent blockage, and have no history of stroke or transient ischemic attack (TIA) within the last 6 months.
The stroke prevention methods 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 open surgery in which surgeons clean out and repair the carotid artery supplying blood to the brain. Carotid stenting is a procedure performed using a catheter where a metal device called a stent is navigated through your arteries and placed in the narrowed part of the carotid to cover the plaque and hold the vessel open. During this procedure, a small umbrella-like instrument called an embolic protection device is placed above the stent to catch any particles that might break away.
All study participants will receive intensive medical management to include lifestyle modifications and medications to prevent clot formation and to reduce blood pressure and bad (LDL) cholesterol. Of the participants selected for carotid revascularization, approximately half will receive cardiac endarterectomy and half a carotid stent.
“We are excited to be a part of this national research,” says Dr. Haghighat. “All of these methods have shown improvements over the years and a reduction in the risk of stroke. Comparing these options to each other in asymptomatic patients will help the medical community to further understand the best way to prevent stroke.”