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 "Catching the clot and fishing it out of the blocked artery to
reopen it makes a big difference in outcome," Dr. Jeffrey Saver, a
director of the University of California Los Angeles Stroke Center,
told Reuters Health. The devices to retrieve clots have been around
for a while but until now “we hadn't had a clinical trial showing
that they made patients better."
Ninety days after their strokes, 32.6 percent of patients whose
treatment included going into a brain artery to remove a clot
achieved functional independence, compared to 19.1 percent given
only usual care with clot-dissolving drugs.
The study, known as MR CLEAN and published online Wednesday by the
New England Journal of Medicine, applies to patients whose strokes
were the result of a blockage in the large forward arteries of the
brain. But that's the most common type of stroke, and the findings
could affect up to 125,000 patients in the U.S. and 90,000 in Europe
each year.
"We're talking about the sickest stroke patients, the ones with
blockages of their main arteries leading to the brain, and these
patients account for the majority of disability and death related to
stroke," study coauthor Dr. Albert J. Yoo, director of Acute Stroke
Intervention at Massachusetts General Hospital in Boston, told
Reuters Health by phone.
Dr. Saver, who was not involved in the study, said the findings
should give people an even stronger reason to get someone to the
hospital as quickly as possible if they demonstrate stroke symptoms,
such as facial drooping, arm weakness or speech difficulties.
"Stroke is now an even more treatable disease today than it was
yesterday," he said, citing the availability in some centers of the
clot-extracting devices that can be used in combination with
clot-dissolving drugs. "But we can only use them if patients get to
the hospital in time."
All the patients in the new study who were treated with the devices
received their surgery within six hours of the onset of symptoms.
Nine out of ten were initially treated with injections of tPA, a
clot-dissolving drug, before the researchers determined who would be
in the group that also received the clot-extraction procedure.
Typically, the clot-busting drug only opens the blocked artery in
about a third of cases.
"Until now, people were lucky to get intravenous tPA. But the
majority of those patients still have poor outcomes," said Dr. Yoo.
"The field was looking for a better option and MR CLEAN showed that
we do have a better option."
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"There was no difference in the death rate, but every other category
demonstrated improvement," he said.
The only significant difference in side effects was that 5.6 percent
of the patients whose clots were extracted had signs of a subsequent
stroke within 90 days. The rate was 0.4 percent in the group that
received standard care.
Past comparisons of tPA and clot-removing devices had given
less-promising results, said Dr. Sidney Starkman, the other
co-director of the UCLA stroke center, who was involved in two of
those earlier studies. That quelled interest in clot-removing
devices.
But the technology has improved dramatically, the new study reflects
those improvements and the latest data should renew interest in
those devices, he said in an interview.
"There has been hesitancy to use these" devices, Saver said, because
"the earlier generation of these devices were not nearly as
effective in opening the blocked arteries and they had not shown a
benefit above medical therapy."
With the new results, "I think there's going to be a push to get
more centers offering this treatment," Yoo said. "We needed the
evidence, and now that we have the evidence, this is going to
provide the impetus to have more centers capable of doing this."
Manufacturers of devices approved for clot removal include Stryker
Neurovascular, Covidien and Penumbra Inc.
SOURCE: http://bit.ly/1AoDt0x New England Journal of Medicine,
online December 17, 2014.
(Refiled to add final paragraph with names of manufacturers)
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