On April 2, Pierre Fayad, M.D., chairman of the University of Nebraska
Medical Centers department of neurological sciences, presented results
from the first randomized study that shows stenting is more effective than
surgery for patients who were otherwise considered very high risk for standard
surgery. Dr. Fayad was among this years presenters at the American Academy
of Neurologys 55th annual meeting in Hawaii. He was one of three speakers
invited to participate in the contemporary clinical issues plenary session,
which highlighted critical neurological issues. More than 7,000 people
attended the AAN meeting, which is the largest neurology meeting in the
world.
This is a major advancement especially for a patients at high risk
for surgery, said Dr. Fayad, a Reynolds Centennial Professor at UNMC and
the only neurologist on the five-member executive committee, which helped
design and organize the large trial.
The Stenting and Angioplasty with Protection in Patients at High Risk
for Endarterectomy (SAPPHIRE) trial also combined stenting in the neck
(carotid) arteries with an AngioGuard filter, a new device to prevent blood
clots and other particles from reaching the brain and causing stroke.
Blockages in the carotid artery are generally treated with a surgery
called carotid endarterectomy, in which the plaque buildup is removed.
In carotid stenting, a balloon-tipped catheter is threaded into the artery,
the balloon is inflated to push back the plaque and a mesh tube, called
a stent, is inserted to keep the artery open.
Surgery and traditional stenting carry risks of creating blood clots
or dislodging particles from the fatty deposits they are trying to clear.
When such debris is unleashed and distributed it can travel to the brain
and cause strokes, Dr. Fayad said. To reduce that risk during surgery,
the artery is clamped while the atherosclerotic plaque is cut out. Stenting
is done without stopping blood flow.
In conjunction with neurologists, vascular surgeons and vascular interventionalists
at UNMC provide carotid stenting to appropriate candidates, said Jason
Johanning, M.D., vascular surgeon, UNMCs department of surgery. Carotid
stenting offers an improved outcome for patients who would otherwise be
at too high a risk for standard surgery.
Trials of carotid endarterectomy done in the late 1980s and early 1990s
showed the surgery was extremely helpful for some patients, but it excluded
patients at high risk of surgery, Dr. Fayad said. We knew the benefits
were there, but they were never tested in these patients, he said. This
is the first trial that tackles this category of people.
Patients at high risk of surgery include those with severe heart disease;
those who have had radiation and narrowing, or blockage, of the arteries
in the neck; those who already had a carotid endarterectomy and the blockage
has returned; and anyone whose jaw would be dislocated during surgery.
The recent trial enrolled 723 patients over three years at 30 institutions.
UNMC did not participate in the trial, which was sponsored by Cordis Corporation,
a Johnson & Johnson company, which pioneers less invasive treatments
for vascular disease.
The study results were first presented in November at the American Heart
Association meeting. Complete results will be published after the patients
have been followed for one year.
In addition to Dr. Fayad, the executive committee includes a cardiologist
from the Cleveland Clinic, who serves as the trials principal investigator;
a vascular surgeon from the Cleveland Clinic; a radiologist from the Miami
Heart Institute; and a radiologist from the University of Pittsburgh.
Dr. Fayads research interests include different aspects of the acute
treatment and prevention of stroke and cerebrovascular disease. He served
as a principal investigator, chairperson or committee member in several
executive and safety monitoring committees for major multi-center and muti-national
clinical trials in stroke and cerebrovascular disease.
Dr. Fayad has published numerous articles and book chapters in such
journals as New England Journal of Medicine, Neurology, Stroke, Neurosurgery,
and Journal of the American Medical Association. He is also a manuscript
reviewer for several journals including Stroke, Journal of Clinical Epidemiology,
Neurosurgery, Annals of Neurology, and Cerebrovascular Diseases.