New Bypass Surgery for Stroke Riskier Than Drug
TUESDAY, Nov. 8 (HealthDay News) -- To prevent stroke in certain
high-risk patients -- those with a blocked neck artery who have
already had a so-called "mini-stroke" -- drug treatment appears as
effective and far less risky than bypass surgery, researchers
Their study evaluated nearly 200 patients, about half of whom
had carotid artery bypass surgery. In the 30 days after surgery,
patients had a 14 percent risk of having a stroke, compared with a
2 percent risk among those treated medically, the study found.
"We were trying to figure out a way of taking people who were at high risk of having stroke and prevent that from happening," said lead researcher Dr. William Powers, chairman of adult neurology at the University of North Carolina School of Medicine, at Chapel Hill.
"The unfortunate part is that we didn't do that," Powers said. "If you made it through the surgery, your risk of having a stroke was 6 percent, but, unfortunately, the risk of having a stroke from surgery was 15 percent," he said. "This procedure should not be used for this propose."
Powers added that despite this failure, they are still looking
for a safer way to get blood to the brain in patients who have a
completely blocked carotid artery, the large blood vessel in the
neck. "We are hoping to take what we learned and take the same type
of patients and try a catheter stent-based approach," he said.
The study appears in the Nov. 9 issue of the
Journal of the American Medical Association.
The surgical procedure is called extracranial-intracranial
arterial bypass surgery. It involves drilling a hole in the head
and attaching a blood vessel from the scalp to one of the blood
vessels of the brain, bypassing the blockage in the neck, Powers
In the trial, called the Carotid Occlusion Surgery Study,
Powers' team randomly assigned 195 patients to carotid bypass
surgery or medical management. These patients were at a high risk
of having a stroke, with a 23 percent risk of having one within two
years, according to Powers.
Based on early findings, the trial was stopped. Over a two-year
period, the researchers found that 21 percent of the patients who
had surgery died or had a stroke, compared with 22.7 percent of
those on medical therapy alone -- which is not a significant
difference, Powers said.
Moreover, at 30 days after surgery, 14.4 percent of the surgical
patients had a stroke, compared with 2 percent of those on medical
therapy. That's a 12.4 percent difference, Powers' group noted.
Commenting on the study, Dr. Ralph Sacco, chairman of neurology
at the University of Miami Miller School of Medicine and past
president of the American Heart Association, said that "medical
therapy with anti-clotting drugs, blood pressure and
cholesterol-lowering drugs has improved over the years, which makes
it more effective.
"Current guidelines would say there is no indication for pursuing a bypass in these patients," Sacco added. "The Heart Association says the procedures should be done with less than a 6 percent perioperative risk in symptomatic patients and 3 percent in asymptomatic patients." Perioperative refers to the period of hospitalization for surgery.
Looking at a larger picture, Dr. Joseph Broderick, professor of
neurology at the University of Cincinnati College of Medicine and
co-author of an accompanying journal editorial, said the
effectiveness of any new therapy needs to be demonstrated before it
can be used.
"Potential new therapies, particularly endovascular reopening of occluded arteries by devices, need to be tested against the standard proven approach of intravenous tPA [a drug that breaks up clots and is standard therapy for stroke]," he said.
"Yet, these devices are already being used in clinical practice since they have been cleared by the FDA for use and are currently reimbursed by Medicare for acute stroke treatment despite a lack of evidence that they improve clinical outcome in acute stroke patients as compared to standard therapy," Broderick said.
This happens because the rules for U.S. Food and Drug
Administration approval and Medicare reimbursement of devices are
different from the rules for approving drugs, he said. This makes
it harder to get people to take part in clinical trials of devices,
because they are in use before they are clinically proven to work,
For more information on stroke, visit the
American Stroke Association.
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