Drug may improve outcomes in mild stroke patients, save $200 million annually

Drug may improve outcomes in mild stroke patients, save $200 million annually
American Stroke Association Meeting Report: Abstracts 75, 207 & 145


Study Highlights:

•Thousands fewer patients may be left disabled and more than $200 million in annual disability costs might be saved if clot-busting drugs can treat mild ischemic stroke.
•Mild strokes were generally excluded in trials of clot-busting treatment because experts believed patients would recover with few lasting effects. A Cincinnati study examined the public health impact of treating mild strokes with clot busters.
•In two unrelated studies, researchers found that nearly a third of stroke patients who arrive at hospitals in time to receive clot busters are excluded because their symptoms are mild; and many more with “rapidly improving stroke symptoms” excluded from clot-buster treatment had poor three-month outcomes.


LOS ANGELES, Feb. 9, 2011 — Treating mild strokes with the clot-busting drug approved for severe stroke could reduce the number of patients left disabled and save $200 million a year in disability costs, according to a study presented at the American Stroke Association’s International Stroke Conference 2011.

Researchers analyzed hospital records from 437 patients diagnosed with mild ischemic stroke at 16 sites in the Greater Cincinnati/Northern Kentucky region in 2005. The patients arrived at the hospital within the 3.5 hours, well within the 4.5 hour window for treatment with intravenous tissue plasminogen activator (tPA).

The federal government has approved the clot-busting drug for strokes caused by blood clots, known as ischemic stroke, which accounts for 87 percent of all strokes. It’s the only acute stroke drug that can reduce disability but remains unproven for treating mild stroke.

“Currently, there is no standard of treatment for patients with the mildest strokes, even if they come into the emergency department quickly enough for intravenous tPA, the only proven treatment for a more serious stroke,” said Pooja Khatri, M.D., lead researcher of the study and associate professor in the Department of Neurology and director of acute stroke at the University of Cincinnati Academic Health Center in Ohio.

“The pivotal randomized trials that proved tPA’s usefulness excluded mild stroke patients because it was thought that they generally did well and the risk of tPA treatment, which includes a slight but significant risk of life-threatening bleeding in the brain, would not be worth the benefit,” she said.

Only four of the mild stroke patients (less than 1 percent) received tPA. The researchers identified 150 of the remaining patients as likely candidates for the drug if the mildness of their stroke was disregarded as a reason to deny them tPA treatment.

Based on the findings, the researchers then excluded those with baseline disability (estimated at 37 percent) and assumed that 8 percent to 13 percent of the remaining mild stroke patients would regain independence after their stroke if tPA was as effective as it was in more serious cases.

Extrapolating to the U.S. population, the researchers said that if tPA proves effective, 2,176 to 3,761 fewer patients would be disabled from mild stroke each year — saving an estimated $200 million in disability expenditures.

In the last five years, researchers conducting several studies have found that about a third of patients who experienced so-called mild strokes remained disabled three months after initial hospitalization.

“It was believed that patients with milder strokes would recover from these events,” Khatri said. “These findings raise the question of whether the mildest strokes should be treated with intravenous tPA.”

Co-authors are: J.C. Khoury, Ph.D.; Kathleen Alwell, R.N.; Charles J. Moomaw, M.S.; Brett M. Kissela, M.D.; Daniel Woo, M.D.; Matthew L. Flaherty, M.D.; Ope Adeoye, M.D.; Simona Ferioli, M.D.; and Dawn O. Kleindorfer, M.D. Author disclosures are on the abstract.

The National Institutes of Health funded the study.

Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing science content. Revenues from pharmaceutical and device corporations are available at www.heart.org/corporatefunding.

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NR11-1011 (ISC 11/Khatri)

ALSO NOTE THESE PRESENTATIONS:
Abstract 207 — Hospital discharge outcomes in mild stroke patients not treated with tPA
More than 31 percent of patients (29,200 out of 93,517) who arrived at a hospital within two hours of symptom onset didn’t receive tPA solely due to mild or improving stroke symptoms, according to data from the American Heart Association’s Get With The Guidelines-Stroke registry.
Yet, a substantial number of those patients had poor outcomes:

•Twenty-eight percent were unable to be discharged to their homes.
•Nearly 29 percent couldn’t walk without help.
•A little more than 1 percent died.


(Note: Actual presentation time: 10:16 a.m. PT, Friday, Feb. 11, 2011)
Abstract 145 — Rapidly improving stroke symptoms: controversial exclusion criterion for tPA
Patients with rapidly improving stroke symptoms (RISS) fared better at three months than those who showed no rapid improvement during their initial hospitalization — but still had substantial poor outcomes, according to a study.
Rapidly improving symptoms is “one of the most common, subjective and poorly defined reasons for excluding patients” from clot-busting treatment, the researchers said.
The study found that an estimated 39 percent to 56 percent of RISS patients were unable to resume all of their pre-stroke daily activities.
Researchers used the data from the 624 patients in the National Institutes of Health/National Institute of Neurological Disorders and Stroke rt-PA Stroke Trial database.
(Note: Actual presentation time: 2:48 p.m. PT, Thursday, Feb. 10, 2011)

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Drug may improve outcomes in mild stroke patients, save $200 million annually