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December 15, 1999

Unlike other promising treatments for acute stroke that improve recovery if administered within three hours of symptom onset, a report in the Dec. 1 issue of the Journal of the American Medical Association (JAMA) describes a treatment which offers significant long-term benefits if administered up to six hours after symptom onset.

A team of investigators from Emory University and elsewhere collaborated on PROACT II: Prourokinase for Acute Cerebral Thromboembolism (PROACT II) trial, to determine if the experimental drug known as recombinant prourokinase (r-proUK) improved the outcome of patients experiencing a certain type of stroke. Principal investigator was Anthony J. Furlan, M.D., of The Cleveland Clinic Foundation.

"As compared with patients receiving low dose IV (intravenous) heparin (a blood thinner) only, patients with ischemic stroke due to MCA (middle cerebral artery) occlusion treated with nine milligrams IA (intra-arterial r-proUK plus low-dose heparin a median of 5.3 hours from onset were 58 percent more likely to have slight or no neurological disability at 90 days," the authors report.

"Because of our conservative technical approach, the results of PROACT II arguably represent the minimum benefit obtainable with IA thrombolysis..."

The multisite team evaluated 180 patients who either received r-proUK plus heparin or heparin alone. Five study subjects were enrolled by Emory investigators at Grady Memorial Hospital and two were enrolled at Emory University Hospital. The Emory team was led by Michael Frankel, M.D., associate professor of neurology at the

Emory University School of Medicine and chief of neurology at Grady Memorial Hospital. Randomized patients received the r-proUK via microcatheter-based "injections" made directly into the MCA (the artery that supplies blood to each half of the brain) by an interventional neuroradiologist

"The group of patients treated in the study had the most severe types of strokes - the kind that almost always have a poor prognosis," Dr. Frankel says. "Overall, the

impact of this new therapy was remarkable. Many patients recovered completely or had minor disabilites from what would have been devastating brain injuries."

Until now, the only medication shown to be effective and approved by the FDA for acute ischemic stroke is tissue plasminogen activator, a clot buster called t-PA, given intravenously within 3 hours of symptom onset. According to Dr. Frankel, "The PROACT study is the first to clearly show that we can successfully intervene within 6 hours from the onset of stroke symptoms by using direct delivery of a clot buster".

Other key members of the Emory Stroke Team in this study included Sharon Sailor, R.N., Owen Samuels, M.D., Greg Joseph, M.D., David Owens, M.D., Barney Stern, M.D., Janet Braimah, R.N., Marc Chimowitz, M.D., and Harriet Howlett-Smith, R.N.

Stroke - or brain attack - occurs when parts of the brain become starved for blood. Ischemic stroke, which comprises 85 percent of strokes, occurs when a blood vessel in the brain becomes blocked by atherosclerosis or a clot. Hemorrhagic stroke is caused by a ruptured blood vessel in the brain.

According to the American Heart Association's 1998 Georgia Stroke Report, stroke symptoms include sudden weakness or numbness on one side of the body; sudden difficulty speaking; sudden dimness or loss of vision, particularly in one eye; unexplained dizziness, unsteadiness or sudden falls; or sudden, severe headaches with no known cause.

The May 1999 issue of Georgia Epidemiology Report, states the following:

-- Georgia's stroke death rate is the sixth highest in the country, and in 1996, Georgia's rate was 24 percent higher than the U.S. rate.

-- Stroke is the third leading cause of death in Georgia, accounting for 4,276 deaths in 1997.

-- In 1997, there were 24,553 hospitalizations for stroke among Georgians, or on average, a hospitalization for stroke every 21 minutes.

-- Stroke is not just a disease of old age: One in five Georgians who died from stroke in 1997 was younger than 65 years of age.

Abbott Laboratories sponsored PROACT II.



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