Stroke patients who receive a stent to open an artery to the brain are at greater risk of another stroke or death, a new study shows.
In a clinical trial of 450 patients,
the half who received brain stents suffered additional strokes or death at
rates more than double compared to the non-stented patients.
The stents were considered so risky
that the National Institute of Neurological Disorders and Stroke stopped
enrolling patients in the trial in April. The National Institutes of Health
released a warning to doctors.
Based on the study, the standard of
care for these high-risk patients with strokes is expected to switch to
lifestyle changes and drug therapies that can lower blood pressure and
cholesterol and reduce the risk of clots.
"The complications on the stent
side of the trial were higher than we expected," said co-principal
investigator Dr. Colin Derdeyn, professor of radiology at Washington University
in a statement. "Further research may identify specific groups of patients
who may benefit from these stents, but for now we seem to be able to save more
lives by aggressively working to lower blood pressure and cholesterol."
The study is reported in the latest
New England Journal of Medicine.
The patients in the study had recent
strokes that were linked to severe stenosis, a blockage or narrowing of major
arteries in the brain. Stenosis is attributed to 50,000 of the 795,000 strokes
a year in the U.S.
While all of the patients received
blood-thinners and drugs for blood pressure and cholesterol, half were chosen
to recieve stents.
Close to 15 percent of patients who
got stents had another stroke or died within the first month after the
procedure. Fewer than 6 percent in the group that did not receive stents had
another stroke or died.
After a year, the stroke or death
rate was 21 percent for patients with stents and 12 percents for the control
group patients.
Researchers speculated that stent
patients may have done worse because their blood vessels were damaged when the
stent was inserted, clots were loosened by the stent or blood clots formed on
the stents.
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