WEDNESDAY, Sept. 7 (HealthDay News) -- Stroke patients who
receive aggressive medical therapy have a better chance of avoiding
a second stroke than those who receive medical therapy plus a stent
in the brain, a new study reveals.
The difference is so significant that a trial was stopped early
because data showed patients who received stents died more often
and had more strokes than those treated with medical therapy
"We hypothesized that stenting would be more effective than medical therapy and found exactly the opposite," said lead researcher Dr. Marc I. Chimowitz, a professor of neurology at the Medical University of South Carolina.
"In this population, given the results of the study, I would recommend aggressive medical management," he said.
There may be a place for stenting in patients who don't respond
well to medical therapy alone, Chimowitz added. However, he has
stopped doing the procedure since seeing the results of this trial,
called the Stenting and Aggressive Medical Management for
Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS)
The report was published in the Sept. 7 online edition of the
New England Journal of Medicine.
For this trial, researchers randomly assigned 451 stroke
patients to aggressive medical treatment or medical treatment plus
a brain stent. The researchers anticipated that stenting would
reduce the risk of recurrent stroke or death by 35 percent over two
The patients were between 30 and 80 years old and in the highest
risk category for stroke, with blockage or narrowing of arteries of
70 to 99 percent. Most patients with less severe blockage receive
medical therapy alone as a matter of course, the researchers
Among those receiving stents, 14.7 percent died or had a stroke
within a month after treatment, compared with 5.8 percent of those
who received medical therapy alone, the researchers found.
Over less than a year of follow-up, 20.5 percent of the stented
patients died or had a stroke, compared with 11.5 percent of those
receiving medical therapy alone, they added.
Based on these numbers, the study's data and safety monitoring
board recommended stopping new enrollment, and the U.S. National
Institutes of Health, which funded the study, issued a clinical
alert. Patients still in the trial will continue to be followed for
another two years, the agency said.
Medical therapy included the blood thinners Plavix (clopidogrel)
and aspirin to reduce the risk of clots, plus blood pressure and
cholesterol medications. Patients also took part in a lifestyle
modification program that focused on quitting smoking, increasing
exercise and controlling diabetes and cholesterol.
Stenting involves placing a tiny metal mesh tube in an artery to
help keep it open. This method is commonly used in heart and leg
arteries. However, stent placement in the brain can dislodge
plaque, causing the artery to become blocked. In addition, the
procedure can damage an artery, causing excessive bleeding.
The system used in the trial -- the Gateway-Wingspan
intracranial angioplasty and stenting system, made by Stryker Corp.
-- is the only system approved by the U.S. Food and Drug
Administration (FDA) for certain high-risk stroke patients. Similar
systems, not FDA-approved, are being used, but were not included in
this trial, the researchers noted.
Despite these findings, Stryker still stands behind its product.
"Stryker continues to support the Wingspan Stent System as an
FDA-approved Humanitarian Use Device for improving cerebral artery
lumen diameter in patients with intracranial atherosclerotic
disease who have failed medical therapy," the company said in a
"The SAMMPRIS trial was focused on the treatment of severe intracranial atherosclerotic disease, earlier in the treatment lifecycle and with a more aggressive drug treatment regimen than is used in standard practice today," the Fremont, Calif.-based company added.
Dr. Joseph Broderick, the Albert Barnes Voorheis Chair of
Neurology at the University of Cincinnati and author of an
accompany journal editorial, said that "at this point using
mechanical devices to prevent strokes is not better than aggressive
Stenting may have a place for those patients who do not respond
to medical therapy. "But there is also a higher risk," Broderick
Given the results of this trial, insurers may not reimburse
doctors for this procedure, Broderick noted. The findings will
likely greatly reduce the number of these procedures, he added.
Another expert, Dr. Larry B. Goldstein, director of the Duke
University Stroke Center, said that "SAMMPRIS is consistent with
other studies showing that current aggressive medical therapy is
associated with considerably lower stroke rates than have been
found in the past."
Goldstein added, "It also underscores the need for adequately
controlled studies of new interventions. The use of expectations
based on historic data can lead to incorrect and potentially
For more information on stroke, visit the
American Stroke Association.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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