Treatment Limits Bleeding Stroke Damage

[February 23, 2008]  NEW ORLEANS (AP) -- Aggressively lowering blood pressure in the early hours of a bleeding stroke can limit its severity, a preliminary study found, giving hope of a major advance for treating this often-fatal problem.

These strokes happen when a vessel in the head bursts or leaks, flooding brain tissue with blood and damaging areas that control walking, talking and other functions. More than 100,000 occur each year in the United States - a million worldwide - and half prove fatal.

"It is a major public health problem," said Dr. Philip Gorelick, neurology chief at the University of Illinois in Chicago and chairman of the International Stroke Conference, where the new study was reported on Friday.

Doctors know that high blood pressure raises the risk of these strokes, but it isn't known if it's safe to rapidly lower it right after one occurs.

The study tested this in 404 stroke patients in Asia and Australia. Half were given usual care - intravenous drugs to lower systolic blood pressure (the big number, or top reading) to 180; the rest had their blood pressure lowered to 140. Normal is 120.

Additional bleeding was about one-third less in the more aggressively treated patients, and the treatment proved safe with no major side effects, said Dr. Craig Anderson of the University of Sydney in Australia, who led the research.

The finding needs to be confirmed in a larger study, but emergency doctors "will probably grab on it," said Dr. Larry Goldstein, director of Duke University Medical Center's stroke center.

The Australian government's health agency paid for the study and will fund one with 2,500 patients starting later this year.

Also at the conference, doctors got mixed news from tests of two treatments for the more common type of stroke - caused by a clot in a blood vessel supplying the brain.

One of the biggest challenges is finding something to help the vast majority of patients who seek help beyond the three-hour window when the clot-busting drug TPA is known to be effective.

Some late-arrivers still have areas of brain tissue that are threatened but might be saved. Researchers in Australia, Belgium, New Zealand and Scotland used imaging tests to identify 101 such patients and gave roughly half of them TPA about five hours after symptoms started.

The main goal - reducing the area of the brain left damaged - was not met. But there were signs that the treatment helped restore the air and blood supply, which should translate to better outcomes for patients when tested in a larger study, research leaders said.

"The trends are going in the right direction; they just haven't proved it," Goldstein said.

A larger study testing TPA beyond three hours is to report results later this year.

TPA is marketed in North America by Genentech as Activase, and by Boehringer Ingelheim in other countries as Actilyse.

A different treatment for people too late for TPA - a mini-vacuum device to suck out clots - opened blood vessels in 82 percent of the 125 patients given the treatment, other doctors reported.

However, 11 percent developed major bleeding in the brain, and another 17 percent had lesser bleeding. In two cases, doctors punctured the blood vessel while trying to suction out the clot. In a third case, another brain bleed developed in a different area.

With TPA, about 6 percent of patients develop bleeding in the brain, and half of those patients die, Gorelick said.

About one-third of patients in the study died - an acceptable result considering how serious these strokes are, he said. Only 42 percent of those whose vessels were reopened had substantial improvement a month later - "and that's the issue," rather than how often the clot can be pulled out, he said.

The device, made by California-based Penumbra Inc., was approved in December by the federal Food and Drug Administration, which requires less proof of effectiveness for devices than for novel drugs, Gorelick and Goldstein said.

The study had no comparison group and was sponsored by the company, they noted. The doctor who presented results - neurosurgeon Cameron McDougall of Barrow Neurological Institute in Phoenix - said he had no control over its design.

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On the Net:

Stroke conference: http://www.strokeassociation.org

[Associated Press; By MARILYNN MARCHIONE]

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