Study Results Released: Landmark National Clinical Trial Shows Surgery and Stenting Equally Safe and Effective to Prevent Stroke
National Institutes of Health presents landmark data today at international stroke conference; St. Joseph Mercy Ann Arbor participant in trial
ANN ARBOR, Mich. A major new study of people at risk for stroke showed that two medical procedures designed to prevent future strokes are safe and effective overall. Physicians will now have more options in tailoring treatments for their patients at risk for stroke.
In the trial of 2,502 participants, carotid endarterectomy (CEA), a surgical procedure to clear blocked blood flow and considered the gold standard prevention treatment, was compared to carotid artery stenting (CAS), a newer and less invasive procedure that involves threading a stent and expanding a small protective device in the artery to widen the blocked area and capture any dislodged plaque.
St. Joseph Mercy Ann Arbor was a part of one of the largest randomized stroke prevention trials ever, the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), which took place at 117 centers in the United States and Canada over a nine-year period. CREST compared the safety and effectiveness of CEA and CAS in patients with or without a previous stroke. The National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), funded the trial, which was led by investigators at Mayo Clinic, Jacksonville, Fla., and the University of Medicine and Dentistry of New Jersey in Newark.
"The CREST trial was a multidisciplinary, collaborative effort between North American cardiologists, neurologists, radiologists and surgeons from a number of carefully selected medical centers who sought to identify the safest and most effective treatment for patients with carotid artery blockages at risk for first or recurrent stroke," commented Herbert D. Aronow, MD, MPH, cardiovascular medicine physician and CREST trial principal investigator at St. Joseph Mercy Hospital.
The overall safety and efficacy of the two procedures was largely the same with equal benefits for both men and for women, and for patients who had previously had a stroke and for those who had not.
“The judicious selection of one of these treatment options may have a major impact on preventing the devastating consequences of stroke,” said Brian G. Halloran, M.D., attending vascular surgeon at St. Joseph Mercy Ann Arbor.
Stroke, the third leading cause of death in the United States, is caused by an interruption in blood flow to the brain by a clot or bleeding. The carotid arteries on each side of the neck are the major source of blood flow to the brain. The buildup of cholesterol in the wall of the carotid artery, called atherosclerotic plaque, is one cause of stroke. Because people with carotid atherosclerosis also usually have atherosclerosis in the coronary arteries that supply the heart, the CREST trial tracked the rate of heart attacks, in addition to stroke and death.
One of the strengths of the study, according to investigators, is that CREST was conducted in a variety of real world settings, including large and small public and private hospitals. Physicians had to demonstrate a high degree of proficiency and safety in order to participate in the trial. The study found no significant differences in the outcomes, no matter what type of medical specialist performed the stenting procedure, including cardiologists, neuroradiologists, interventional radiologists, vascular surgeons and neurosurgeons.
The CREST investigators concluded that while CEA has a proven record and long term durability, both CAS and CEA are safe and useful tools in the right setting for stroke prevention, and technology continues to improve each procedure.
"As a cardiovascular specialist with an interest in stroke prevention, I am thrilled that we now have a less invasive but equivalent option for the treatment of patients with carotid artery blockages,” concluded Aronow. "The CREST trial results will change our current treatment paradigm, affording patients an additional, equivalent yet minimally invasive option for stroke prevention."