Beaumont Participates in Landmark NIH Stroke Prevention Study

Beaumont Hospital, Royal Oak was one of six Michigan hospitals to participate in one of the largest stroke prevention trials in North America. The National Institutes of Health study compared the results of treating blockages in the carotid arteries with surgery or stenting.

Explained O. William Brown, M.D., principal Beaumont investigator and director of Vascular Surgery, "This is an important study. It confirms the safety and effectiveness of carotid artery stenting in selected patients with carotid artery disease.  The study also confirms that of all treatment options, carotid endarterectomy is associated with the lowest incidence of stroke.  It's important that treatment be individualized for each patient.  At Beaumont Hospitals, we offer both options by highly qualified vascular specialists, many of whom participated in the CREST study."

Beaumont began recruiting study participants in November 2003 and was the top Michigan site for patient enrollment. The trial took place at 117 centers in the United States and Canada over a nine-year period. 

According to NIH findings announced today, 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.

The Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) was one of the largest randomized stroke prevention trials ever.  CREST compared the safety and effectiveness of CEA and CAS in patients with or without a previous stroke.  The trial was funded by the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health.

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.  However, when the investigators looked at the numbers of heart attacks and strokes, they found differences.  The investigators found that 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.  At approximately age 69 and younger, stenting results were slightly better, with a larger benefit for stenting, the younger the age of the patient.  Conversely, for patients older than 70, surgical results were slightly superior to stenting, with larger benefits for surgery, the older the age of the patient. 

"The CREST trial results show that we now have two safe and effective methods to treat carotid artery disease directly, the tried and true CEA, and the new kid on the block, CAS," said Thomas G. Brott, M.D., professor of neurology and director for research at Mayo Clinic in Jacksonville, and the study's national principal investigator.  "There was evidence that people who were younger than 70 did better with stents while those over 70 had better results with the surgery, but the results for all men and women were excellent."

"The CREST trial provides doctors and patients with much needed risk/benefit information to help choose the best carotid procedure based on an individual's health history.  This personalized decision making should translate into improved patient outcomes," said Walter J. Koroshetz, M.D., deputy director of NINDS. 

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.

In CREST, approximately half the patients had recent symptoms due to carotid disease such as a minor stroke, or a transient ischemic attack (TIA), indicating a high risk for future stroke.  The other half had no symptoms but were found to have narrowing of the carotid artery on one of a variety of tests assessing carotid narrowing and plaque.  Such patients, termed asymptomatic, are at much lower risk of stroke than those with symptoms.

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.