Wednesday, March 25, 2015
Researchers hope to learn more about the best treatment for stroke prevention
Beaumont Hospital, Royal Oak is now enrolling patients in a major, North American stroke prevention study. Researchers will compare intensive medical management to carotid endarterectomy, a common operation to prevent stroke, and to carotid artery stenting.
Qualified participants are needed at Beaumont, Royal Oak over the next five years, according to O. William Brown, M.D., lead study doctor and section head, Vascular Surgery, Beaumont, Royal Oak. To qualify, participants must:
- be at least 35 years old
- have a significant narrowing of one carotid artery with at least 70 percent blockage
- have no history of stroke or transient ischemic attack, or TIA, within the past six months
Beaumont, Royal Oak is one of up to 120 medical centers that will be participating in the study, seeking 2,480 participants across the United States and Canada. The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Study, or CREST-2, is supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health.
“Physicians want to identify the best way to prevent stroke in people who have a narrowing in their carotid artery,” explains Dr. Brown. “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.”
Three stroke prevention methods will be studied:
- intensive medical management
- intensive medical management with carotid endarterectomy
- intensive medical management with carotid stenting
Carotid endarterectomy is a surgical procedure where surgeons clean out and repair a main artery supplying blood to the brain. The carotid arteries branch off the aorta near the heart and extend upward along both sides of the neck carrying oxygen-rich blood to the brain. Carotid stenting is a procedure in which 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 procedure, a small umbrella-like instrument called an embolic protection device is placed above the stent to catch any particles that might break away.
Adds Dr. Brown, “To date, no research has been conducted to compare the treatment differences between intensive medical management and two procedures- carotid surgery and stenting. CREST-2 is intended to compare the two procedures to intensive medical management in patients without recent stroke and without stroke warning signs. Most importantly, we hope to gain a better understanding of whether medicines alone can treat this condition. The information from this study will help us learn more about the best treatment for stroke prevention.”
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.
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. All participants will receive intensive medical management.
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/bad cholesterol and a personal risk-modification coach to review ways to quit tobacco, manage weight and increase physical activity.
Stroke is the fourth most common cause of death in the United States and the leading cause of disability in adults. For the past 20 years, medical management of stroke risk factors has improved such that risk of stroke from carotid stenosis has been significantly reduced. Carotid endarerectomy and carotid stenting, both revascularization procedures, have also improved.
For more information on the CREST-2 study at Beaumont and patient participation criteria, please contact the study research nurse clinician at 248-551-1113. Information is also available at www.crest2trial.org.