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MEDICAL: RESEARCH :
MEDICAL: TREATMENT :
MEDICAL: SURGERY :
MEDICAL: CONDITIONS: CEREBRAL ACCIDENTS (STROKES):
Landmark NIH Clinical Trial
Comparing Two Stroke Prevention Procedures
Shows Surgery and Stenting Equally Safe and Effective
Date: Fri, 26 Feb 2010 09:36:18 -0500
From: "NIH OLIB (NIH/OD)" <[log in to unmask]>
To: [log in to unmask]
Subject: Landmark NIH Clinical Trial
Comparing Two Stroke Prevention Procedures
Shows Surgery and Stenting Equally Safe and Effective
U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News
National Institute of Neurological Disorders and Stroke (NINDS)
<http://www.ninds.nih.gov/>
Embargoed for Release: Friday, February 26, 2010, 8:30 a.m. CST
CONTACTS:
NINDS:
Marian Emr
301-496-5924
e-mail:
[log in to unmask]>301-496-5924
Margo Warren
301-496-5924
e-mail:
[log in to unmask]
Mayo:
Kevin Punsky
904-953-2299
e-mail:
[log in to unmask]
Nancy Jensen
904-953-2299
e-mail:
[log in to unmask]
LANDMARK NIH CLINICAL TRIAL COMPARING
TWO STROKE PREVENTION PROCEDURES
SHOWS SURGERY AND STENTING EQUALLY SAFE AND EFFECTIVE
Opportunities Exist to Target the Treatment to the Patient
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.
One of the largest randomized stroke prevention trials ever, the Carotid
Revascularization Endarterectomy vs. Stenting Trial (CREST) 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 trial was funded by the National Institute
of Neurological Disorders and Stroke (NINDS), part of the National
Institutes of Health, and led by investigators at Mayo Clinic,
Jacksonville, Fla., and the University of Medicine and Dentistry of New
Jersey in Newark.
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.
"Although the purpose of the study was to compare the two procedures, we
were pleased to find that both CEA and stenting have become
extraordinarily safe," said Gary Roubin, M.D. Ph.D., chairman, department
of cardiovascular medicine, of the Lenox Hill Hospital in New York City, a
lead investigator for CREST and study co-principal investigator for
stenting.
The researchers point out that the rate of stroke and death in the
surgical group was the lowest ever reported in a large stroke prevention
trial. "The rate for stroke and death in carotid stenting was also the
lowest yet reported in any randomized trial, and significant advances in
technology, technique and patient selection for stenting have continued
over the eight-year enrollment in CREST," said Dr. Roubin.
As a result, the pivotal differences were the lower rate of stroke
following surgery and the lower rate of heart attack following stenting,
according to the investigators. A year after the procedure, the patients
who had suffered a stroke reported that the effects of the stroke had a
greater impact on their quality of life than was reported by those
patients who had suffered a heart attack.
The average age of the patients in this trial was 69. "These patients have
many good years ahead of them, and that's why the lessons learned from
CREST are so important. People have some very good options for stroke
prevention that we hope will not only extend the length but also the
quality of their lives," said Dr. Brott.
"CAS may offer a reasonable alternative to CEA, particularly in patients
who prefer a less invasive procedure, and in younger patients. However, it
should be kept in mind that for the endpoint of stroke, CEA has been shown
to be the safer procedure. It is when heart attacks are added that the
results of the two procedures become similar," said Wesley S. Moore, M.D.,
professor and chief, emeritus, division of vascular surgery of the
University of California at Los Angeles, and coprincipal investigator for
surgery in the CREST trial. Dr. Moore went on to say that it is also
important to point out that the complications from either procedure in
this study are the lowest reported to date and are a tribute to the
quality of the surgeons and interventionists who participated in this
trial.
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.
"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.
Mayo Clinic is the first and largest integrated, not-for-profit group
practice in the world. Doctors from every medical specialty work together
to care for patients, joined by common systems and a philosophy of "the
needs of the patient come first." More than 3,700 physicians, scientists
and researchers, and 50,100 allied health staff work at Mayo Clinic, which
has campuses in Rochester, Minn.; Jacksonville, Fla.; and Scottsdale,
Ariz.; and community-based providers in more than 70 locations in the
upper Midwest. For more Mayo Clinic news, visit
<http://www.mayoclinic.org/news>
The NINDS
<http://www.ninds.nih.gov>
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. For more information about NIH and its
programs, visit
<http://www.nih.gov>
##
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