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Landmark Clinical Trial Shows Surgery and Stenting Equally Safe and Effective at Preventing Stroke
Date:5/26/2010

Physicians now have more options in tailoring treatments for patients at risk for stroke.

(Vocus) May 26, 2010 -- After nine years of investigation, the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), conducted in part by University at Buffalo Neurosurgery, shows that two different procedures designed to prevent future strokes are safe and effective overall. In the trial of 2,502 participants, carotid endarterectomy (CEA), a surgical procedure considered the gold standard prevention treatment, was compared to carotid artery stenting (CAS), a newer and less invasive procedure that involves expanding a small device in the artery to widen the blocked area and capture any dislodged plaque. The trial was funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH). Results of the study appear today in the online first edition of the New England Journal of Medicine.*

The CREST trial was performed at 117 medical centers in the United States and Canada and is considered one of the largest randomized stroke trials ever conducted. University at Buffalo Neurosurgery played a key role in the investigation as a leading enroller and the designated CAS training site for more than 200 surgeons, neurosurgeons, radiologists, and cardiologists participating in the study. University at Buffalo Neurosurgery is one of the busiest neuroendovascular laboratories and one of the most experienced and successful practitioners of carotid stenting in the world.

Results of the CREST trial show that the overall safety and efficacy of the two procedures was largely the same, with equal benefits for men and women, and for patients who had previously had a stroke and for those who had not. However, when the investigators looked at the numbers of heart attacks and strokes, they found differences: there were more heart attacks in the surgical group (2.3 percent compared to 1.1 percent in the stenting group) and more strokes in the stenting group (4.1 percent versus 2.3 percent for the surgical group) in the weeks following the procedure.

The study also found that the age of the patient made a difference. For patients aged 69 years and younger, stenting results were slightly better. In fact, the younger the patient was at the time of procedure, the larger the benefit of stenting. Conversely, for patients older than 70, surgical results were slightly superior. As the age of the patient increased so did the benefits of surgery over stenting.

According to L.N. Hopkins, M.D., chairman of University at Buffalo Neurosurgery, “The question is no longer whether we can use stents to prevent strokes. Now, it’s determining the best candidates.”

Stroke, the third leading cause of death in the United States, is caused by an interruption of blood flow to the brain by a clot or bleeding. Because 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 a leading cause of stroke.

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, and by a number of different types of specialists, including neurosurgeons, cardiologists, neuroradiologists, interventional radiologists, and vascular surgeons. Most importantly, 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.

“For a patient considering carotid treatment, the most important thing is a second opinion,” says Dr. Hopkins. “When the risk of a procedure is stroke, you want to be sure to choose a well-trained, experienced physician—no matter his or her specialty.”

CREST investigators point out that the rate of stroke and death was the lowest ever reported in a large stroke prevention trial, and 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, especially as advances in technology and patient selection continue to improve each procedure. CAS may be particularly useful for younger patients and for those patients who require a less invasive, less expensive treatment option.

“The CREST trial was a large, complex undertaking that will provide the medical community with important information on the comparative effectiveness of these two procedures. NINDS is committed to long-term follow up of this group of patients, which will help us learn even more about how best to prevent stroke,” said Story Landis, Ph.D., NINDS director.

Partial funding for the study was supplied by Abbott, of Abbott Park, Ill., the maker of the stents.

About UBNS

University at Buffalo Neurosurgery, Inc. (UBNS) is an academic neurosurgical group and leading regional referral center for cerebrovascular disorders run by a distinguished team of neurosurgical specialists and subspecialists committed to superior patient care, resident education, and translational research. UBNS diagnoses and treats a wide range of neurological conditions, including but not limited to aneurysms; stroke; back and neck pain; epilepsy; Parkinson’s disease; hydrocephalus; and tumors of the brain, spine, and skull base. It is also the only neurosurgical group in Western New York with FDA approval to conduct device-related clinical trials for acute stroke. Visit www.ubns.com for more information.

About the NINDS/NIH

The National Institute of Neurological Disorders and Stroke (NINDS) is the nation’s leading funder of research on the brain and nervous system. The NINDS mission is to reduce the burden of neurological disease – a burden borne by every age group, by every segment of society, by people all over the world.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases.

 
  • Brott,TG et al., Stenting Compared to Endarterectomy for Treatment of Carotid Artery Stenosis, New England Journal of Medicine, online first edition May 26, 2010.

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Read the full story at http://www.prweb.com/releases/2010/05/prweb4053054.htm.


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