Major NIH Study Finds Stents, Surgery Safe and Effective

NEWARK, N. J. (February 22, 2010) –– A major new NIH study with important roots at Saint Michael's Medical Center shows that surgery and stenting are both safe and effective treatments for people at risk of stroke.
       
The research, which followed more than 2,000 participants over nine years, gives doctors another tool to prevent stroke, the nation's third leading cause of death, said Dr. Zafar Jamil, chief of vascular surgery at Saint Michael's Medical Center and the principal investigator of the CREST study in New Jersey.
       
“For the first time, we have been offered an alternative method to treat patients. The study has proven that surgery and stents are equally effective,” said Dr. Jamil, a surgeon with 25 years of experience. “The study also shows us that carotid surgery has stood the test of time.”
       
The trial compared carotid edarterectomy, a surgical procedure to clear blocked blood  vessels  and considered the gold standard preventive treatment, with carotid artery stenting, a newer and less invasive procedure. Stenting involves threading and expanding a small protective device in the artery to widen the artery and capture any dislodged plaque.
       
The CREST study protocol was created by Dr. Robert Hobson, a prominent vascular surgeon at Saint Michael's Medical Center and a professor at UMDNJ. The surgeon devoted much of his life's work to preventing stroke. He died in 2008.
       
“This study is a tribute to Dr. Hobson and a legacy of his life's work,” said Dr. Jamil.
        
About 12 years ago, Dr. Hobson and Dr. Jonathan Goldstein, a cardiologist and Director of Medicine at Saint Michael's, began discussing alternatives to carotid surgery. The two traveled to areas where carotid stenting was being performed, and brought what they learned back to Saint Michael's.
       
“We thought, 'Who should do this procedure?' Vascular surgeons are not trained to do stents, but coronary doctors are not trained to work in the carotid? This technique is a marriage of skills,” said Dr. Goldstein. Dr. Hobson's protocol to study the new technique was accepted by the NIH and became the basis for the nine-year, landmark CREST study conducted at 117 centers.
       
“The data from this study will be mined for years to come and will improve the way we prevent strokes,” said Dr. Goldstein.
       
The study shows the benefits and risks of both procedures. The study showed a higher rate of stroke for stent patients, 4.1 percent versus 2.3 percent for carotid endartectomy. The study also found that there were more heart attacks in the surgical group, 2.3 percent compared to 1.1 percent in the stenting group.
       
“The takeaway message of this study is that a procedure – carotid stenting with a protective device is as good, and in some cases better, than carotid surgery. Carotid surgery has been the gold standard and now there is a new procedure in town,” said Dr. Goldstein. He has performed more than 600 carotid stents.
       
Both doctors said the skill and expertise of the practitioner must be taken into consideration, regardless of whether surgery or stenting is selected. In addition, doctors must determine which intervention is most appropriate for individual patients.
       
The carotid arteries on each side of the neck are the major source of blood flow to the brain. Stroke is caused by an interruption in blood flow to the brain by a clot or bleeding. The buildup of cholesterol in the wall of the carotid artery, called atherosclerotic plaque, is one cause of stroke.  Because people with narrowing of the arteries in the neck often have similar problems in their heart vessels, the CREST trial tracked the rate of  heart attack as well as stroke and death.
       
The study also found that the age of the patient made a difference.  At approximately age 69 and younger, stenting results were slightly better. The younger the patient the greater the benefits. Conversely, for patients older than 70, surgical results were slightly superior to stenting. The older the patient, the larger the benefits.
       
The CREST trial continues Saint Michael's history as an important center for carotid research and innovation.
       
“Saint Michael's has been an important element in all three of the major national carotid studies and will play an important role in future research,” said Dr. Jamil.
       
The study will have far-reaching affect on stroke prevention.
“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 Dr. Walter J. Koroshetz, deputy director of National Institute of Neurological Disorders and Stroke.

Established by the Franciscan Sisters of the Poor in 1867, Saint Michael’s Medical Center is a 357-bed regional tertiary-care, teaching and research center in the heart of Newark’s business and educational district. Saint Michael’s Medical Center is a member of Catholic Health East (CHE). Based in Newtown Square, Pennsylvania, Catholic Health East is one of the nation’s largest nonprofit health systems, with 34 hospitals in 11 states. More information is available at www.smmcnj.org.