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A minimally invasive procedure to clear plaque-filled neck
arteries is as effective as traditional surgery in patients at high risk for
open surgery, according to new Cleveland Clinic-led research. The minimally
invasive treatment uses a stent in combination with a special filter to catch
any emboli, or bits of plaque, that break free during the procedure.
"Our findings indicate that for patients with coexisting
disease, such as coronary artery disease or heart failure, carotid stenting with
embolic protection is an excellent treatment option," said lead researcher
Jay Yadav, M.D., Director of Vascular Intervention at the Cleveland Clinic.
"Because many patients with carotid artery disease have
other conditions that make them poor candidates for surgery, it’s important
that we find safe, effective alternatives in order to better manage their
disease and reduce their risk of stroke," said Dr. Yadav, who helped to
design the filter used in the study.
The SAPPHIRE (Stenting and Angioplasty with Protection in
Patients at High Risk for Endarterectomy) study is the first study to compare
carotid stenting with embolic protection to traditional open surgery to clear
clogged neck arteries and restore blood flow to the brain in high-risk surgical
patients. The traditional surgery, called a carotid endarterectomy, is
considered the current "gold standard" for treating carotid stenosis.
In people with carotid stenosis, plaque builds up and narrows
the carotid arteries. Similar to the process by which arteries in the heart
become blocked and cause a heart attack, untreated carotid stenosis can cut off
blood supply to the brain, causing a stroke.
Unlike the traditional surgery, which involves cutting open
the carotid arteries to clean them, carotid artery stenting is a minimally
invasive procedure that does not require a large, open incision. Carotid
stenting involves feeding a stent, a wire mesh device used to open a narrowed
artery, up to the neck through a catheter near the leg. This process can cause
small pieces of plaque to break off and enter the bloodstream.
To reduce the chance of this, SAPPHIRE researchers used an
emboli-protection device to catch these small particles. The device, which looks
like a tiny umbrella, is opened in the artery above the placement of the stent.
Once the stent is in place and deployed, the emboli-protection device is
collapsed and removed with the trapped particles inside.
The SAPPHIRE study included 334 high-risk patients at 29
treatment centers around the United States. Patients were randomly assigned to a
procedure only if caregivers agreed the patient was a suitable candidate for
either stenting or endarterectomy. Of the 167 patients randomly assigned to
stenting, 159 received the assigned treatment. Of the 167 patients assigned to
surgery, 151 received the assigned treatment. The primary end point of the study
was the rate of major adverse events, defined as death, stroke or heart attack
within 30 days of the procedure, or death or stroke between 31 days and one year
following the procedure.
Of the patients assigned to stenting, 20 of the 167
experienced a major adverse event vs. 32 of the 167 assigned to surgery. The
rate of major adverse events was 39 percent lower among patients randomly
assigned to protected carotid-artery stenting. Rates of bleeding complications
were similar, but the length of hospital stay was longer in the patients
assigned to surgery. These findings show that for high-risk patients, the less
invasive stent treatment is at least as effective as surgery.
"We are excited to have found a comparable alternative
for surgery in high-risk patients," said Kenneth Ouriel, M.D., division
chairman of surgery and department chairman of vascular surgery at The Cleveland
Clinic. "This should make a big difference in patient management in the
future."
Complete study results appear in the October 7, 2004 issue of The
New England Journal of Medicine. Funding for the study came in part from
Cordis, a unit of Johnson & Johnson, which manufactures and markets the
stents and emboli-protection devices used in the trial.
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