Major Finding: Treating mild stroke with tPA could save almost 4,000 patients from long-term disability and save $200 million each year in associated health care costs.
Data Source: An epidemiologic study of 247 patients with mild stroke, extrapolated to the entire U.S. population.
Disclosures: The study was sponsored by the National Institutes of Health; neither Dr. Khatri nor any co-authors had any financial disclosures.
LOS ANGELES — The use of tissue plasminogen activator in patients with mild stroke could save thousands of them from long-term disability, and about $200 million each year in stroke-related health care costs.
The decision to administer tPA to patients with mild stroke is a difficult one, balancing the possible benefits with the risk of further bleeding, Dr. Pooja Khatri said at the meeting. But her epidemiologic study of 150 mild strokes suggests that administering the drug could prevent the disability that affects up to one-third of these patients.
Her retrospective study drew its data from the Greater Cincinnati/Northern Kentucky Stroke Study. The database included 441 patients who were treated for ischemic stroke during 2005. Of those, 56% (247) had strokes that were considered mild, with a baseline modified Rankin Scale score of 2–6. And, of those patients, 62% (150) were considered eligible for tPA treatment; however, only 1% (4) received the drug.
Dr. Khatri, director of acute stroke at the University of Cincinnati Academic Health Center, did not follow the patients to compare clinical outcomes over time. However, she said, based on two extant studies, about 30% of mild stroke patients do experience deficits that affect their lives. “These tend to be on the milder end of the spectrum, but it's still disability.”
She extrapolated her findings to the entire U.S. population in 2010, estimating that mild strokes would have occurred in 27,203 patients without baseline disability. If all of the these patients had received an effective treatment, up to 13% (3,761) could have been saved from stroke-related disability.
The estimated annual cost savings could be immense, she said. “We could see a savings of $200 million across the country,” an estimate that includes the potential costs of adverse events associated with widening the treated population.
But her data don't directly address the day-to-day decisions clinicians have to make when faced with a mild stroke patient. Very few mild stroke patients receive tPA treatment, she said, because the potential gains are regarded as small against the risk of hemorrhage. Most of the time, things go well when treating mild stroke patients, because the risk of bleeding lessens with stroke severity. “But sometimes we get burned,” Dr. Khatri said. “That [untreated] patient may end up being paralyzed on one side or having cognitive problems that we didn't recognize. … On the other hand, we may treat and that patient can bleed and perhaps even die.” The dilemma can be answered only by a large, randomized trial, she said – something she and her colleagues at the University of Cincinnati are trying to get started.
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A Balancing Act That Could Pay Off
This study is a wake-up call, from the standpoints of both cost and the patient's daily life. From it, we can argue that every stroke is significant, so we must take all mild strokes very seriously when deciding treatment.
It's difficult to balance the risks of tPA treatment with the benefits in patients with mild stroke. It's true that the potential gain of treatment is smaller than that with a more severe stroke. On the other hand, tPA-related bleeding is less of a risk with mild stroke because the area of brain injury is smaller.
Treating mild stroke also may have some preventive role. We have a series of interventions we can use that lower the risk of subsequent stroke for people whose quality of life may not be seriously impaired after a mild stroke, but will be if they have another and another.
STEVEN GREENBERG, M.D., is professor of neurology at Harvard Medical School and director of hemorrhagic stroke research at Massachusetts General Hospital, both in Boston. He said he has no relevant conflicts of interest.