The first patients are being enrolled at Miami Cardiac and Vascular Institute at Baptist Hospital in a major national study comparing intensive medical management to carotid endarterectomy, a common operation to prevent stroke, and to carotid artery stenting.
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 Institutes of Health.
Miami Cardiac & Vascular Institute at Baptist Hospital is one of up to 120 clinical centers participating in the study, which is seeking 2,480 participants across the United States and Canada.
Qualified participants are needed at Miami Cardiac and Vascular Institute over the next five years, according to Barry Katzen, MD, principal investigator for the research study at Miami Cardiac and Vascular Institute.
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.
“Physicians want to identify the best way to prevent strokes in people who have a narrowing in their carotid artery,” Dr. Katzen said.
The CREST-2 trial is designed to compare three different methods of stroke prevention to find the safest and most effective treatment for patients with carotid artery narrowing. The stroke prevention methods include intensive medical management, or intensive medical management combined with carotid endarterectomy (CEA) or combined with carotid stenting (CAS). 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 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.
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 the CREST-2 trial, the stroke prevention method includes using aspirin to prevent blood clot formation, prescription medications 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.
Doctors who have demonstrated safety and expertise in the carotid surgery and carotid stenting will be performing the procedures for the trial. 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. Katzen leads the interventional team at Miami Cardiac and Vascular Institute; Athanassios Tsoukas, MD, leads the surgical team; Brad Herskowitz, MD, leads the neurological team, and Ian Del Conde Pozzi, MD, leads the medical management team. Other doctors from Miami Cardiac and Vascular Institute participating in the CREST-2 study include interventionalists James Benenati, MD; Guilherme Dabus, MD; Italo Linfante, MD, and neurologist Allan Herskowitz, MD.
Stroke is the fifth most common cause of death in the United States and the leading cause of disability in adults. 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.
To date, no research has been conducted to compare the treatment differences between medical management and these two procedures.
The CREST-2 study is intended to compare the two procedures to intensive medical management in patients without recent stroke and without stroke warning signs.
“The information from this study will help us learn more about the best treatment for stroke prevention,” Dr. Katzen said.
Miami Cardiac and Vascular Institute is part of Baptist Health South Florida, the largest faith-based, not-for-profit healthcare organization in the region. It also includes Baptist Hospital, Baptist Children’s Hospital, South Miami Hospital, Doctors Hospital, West Kendall Baptist Hospital, Homestead Hospital, Mariners Hospital and Baptist Outpatient Services.
For more information, visit www.BaptistHeart.net.