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May 8, 2000
News this month Strokes afflict more than 600,000 Americans each year. About 43 percent of these are women, but women account for more than 60 percent of stroke deaths. The great majority of the time, the culprit is some kind of clot that obstructs the flow of blood through an artery, where for a variety of reasons, blood-starved brain cells don't die right away. If the offending clot is broken up quickly enough, normal blood flow is restored and the brain is spared. "tPA…is…the only medication approved
for the treatment of acute ischemic stroke."
In 1996, the U.S. Food and Drug Administration approved a clot-dissolving drug called tissue-type plasminogen activator (tPA) for use in stroke patients. It is, to date, the only medication approved for the treatment of acute ischemic stroke. The approval was based on the results of a clinical trial sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) that found substantial and statistically significant benefits in stroke patients. Proper use of tPA "tPA…must be administered within three
hours of the first symptom of a stroke…"
Strict guidelines apply to tPA usage. It must be administered within three hours of the first symptom of a stroke; and, in addition to this three-hour treatment window, patients who have been taking blood thinners, whose blood pressure is out of control or who have a few other health problems are not supposed to receive tPA. When administered by experienced doctors, tPA can improve the recovery of stroke patients, according to two studies published in the Journal of the American Medical Association in March. But these studies find that physicians often give the medication to patients who shouldn't receive it and sometimes don't administer it quickly enough. STARS Study However, these researchers also found that about a third of the time, physicians violated the treatment guidelines for using tPA, often giving it after the three-hour limit and when patients had taken blood thinners, both contraindications based on treatment guidelines. "…patients did better overall, but it
should be a wake-up call to physicians that we need to treat them
sooner in the ER."–Dr. Gregory
Albers, Stanford Univ.
"I think the findings should be a reassuring message to consumers since one of the most convincing things about the study was that patients did better overall, but it should be a wake-up call to physicians that we need to treat them sooner in the ER," said Dr. Gregory Albers of Stanford University who led the STARS study. Cleveland area study Only 70 of these patients, just 1.8 percent, were given tPA, suggesting that eligible patients were probably not being treated. Treatment guidelines were violated in half of those who got the drug, and those violations contributed to a slightly higher death rate and more cases of bleeding in the brain. Both studies showed physicians seem to be giving tPA at the latest possible minute, with patients getting the medication, on average, two hours and 44 minutes after symptoms began. According to Dr. Irene Katzan, the lead researcher in the second study
who is with the Cerebrovascular Center of the Cleveland Clinic, this
study suggests education is needed for all physicians in all specialties.
"While I think the report is important, it should serve to remind
us of the importance of following the national guidelines." Patients
should be encouraged to seek early care, she emphasized, since the
consequences of stroke are so devastating.
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 tPA offers hope for recovery The anti-clotting drug tPA has been used in heart attacks for several decades, but we have been cautious about using it for stroke patients because of concerns about bleeding in the brain. The study conducted in 1995 by the National Institute of Neurological Disorders and Stroke (NINDS) demonstrated that if patients were carefully selected to minimize the risk of bleeding and treated within three hours with a slightly lower dose of tPA than is used for heart attacks, it can improve outcomes. If the drug is used according to guidelines, tPA improves the odds of being cured from stroke by 30 percent. "…tPA improves the odds of being cured from stroke by
30 percent."
The guidelines exclude patients with very high blood pressure, those who take blood thinners such as coumadin and those who have recently had surgery. Even if the guidelines are followed, the original study showed the drug does carry an increased bleeding risk of 6.4 percent particularly among elderly patients and those who had experienced very severe strokes. The results of the STARS Study relieve some concern about a possible increase in the rate of dangerous side effects when the drug moves out of clinical trials and into real-world use. The new multicenter study found the risk of intracranial hemorrhage after tPA treatment does not outweigh the clear benefits of the drug for most patients. The results indicate an even lower risk of bleeding, 3.3 percent, than might have been expected based on earlier studies. "…risk of intracranial hemorrhage after tPA treatment does not outweigh the clear benefits of the drug for most patients."
The Cleveland area study indicates, however, a higher risk in clinical settings. About half of the patients treated with tPA in this study did not meet the drug’s guidelines, and the risk of bleeding, about 16 percent, was more than double that of earlier studies. Why the higher risk? It’s difficult to say. Two major hospitals in the Cleveland study who admitted large numbers of stroke patients failed to use tPA on any of their patients. Some of the results may reflect the pro- and anti-tPA camps that existed soon after the FDA’s approval of the drug in 1996. "…how well you do depends to a large extent on two factors:
the experience of the team that treats you and how quickly you seek
help."
What you need to know Yet because many people aren't aware that anything can be done to treat stroke, only 5 percent of stroke victims make it to the hospital in time to be helped. The pain of a heart attack motivates people to call 911 right away, but someone who drops a coffee cup or has trouble talking often goes to bed in hopes of feeling better later. Getting to the hospital quickly is critical. Call 911 if you think you may be having a stroke or if you are with someone you suspect might be having a stroke. Watchful waiting only makes it more difficult for a stroke sufferer to receive treatment in time to prevent permanent brain damage. Stroke symptoms include sudden onset of symptoms such as:
The challenge of treating stroke patients within such a narrow time window is compounded by the fact that tPA is not warranted in every situation. In a hemorrhagic stroke, caused when a blood vessel in the brain ruptures and blood pools in the surrounding tissue, tPA treatment would be very dangerous. It could cause additional bleeding in the brain. The drug is used to treat acute ischemic stroke only, which occurs when a clot lodges in a blood vessel in the brain and blocks the normal flow of blood. The oxygen-starved brain cells downstream of the obstruction quickly begin to die. This difference in cause and treatment make a correct yet speedy diagnosis particularly essential. Emergency room physicians use a CT scan to quickly visualize the brain and determine which type of stroke is affecting the patient before deciding on a course of treatment. In addition to intravenous injections of tPA, there are ongoing investigational trials assessing the effectiveness of direct injection of anti-clotting medications into a catheter threaded through the arteries of the brain to deliver treatment directly to the site of the clot. This approach on appropriate patients can be used as long as six hours after the onset of a stroke. Prevention the best cure Finding the right care Then if stroke occurs, don't forget to act. Most stroke patients who
got treated in time did so because they or someone nearby recognized
the symptoms and got them to the hospital in a hurry. Dr. Fayad is a neurologist on staff at Yale-New Haven Hospital, associate professor of neurology at the Yale School of Medicine, co-director of the Yale Cerebrovascular Center and director of the Yale Vascular Neurology Program. |
