NEW YORK TIMES Health Section
By Laurie Tarkin, Jenny Warburg for The New York Times
Of the estimated 730,000 Americans who have strokes each year, nearly 160,000 die and another 400,000 suffer varying degrees of disability. Yet, when stroke patients arrive at emergency rooms, medical experts say, they are not usually treated with the urgency required.
The less-than-rapid response, in some cases, can make the difference between full recovery and permanent debilitating disease or death.
The response has its roots in the medical field’s long-held fatalistic view of stroke. A stroke occurs when the blood supply to brain cells is cut off, most commonly by a blood clot (ischemic stroke) in a blood vessel of the brain, and less frequently, by a hemorrhage. In minutes, the starved brain cells begin to die.
In the past, doctors could do little to stop a stroke, so they simply monitored the patient and tried to prevent secondary complications certainly not an urgent situation.
But in 1996, the first drug, a tissue plasminogen activator, or T.P.A., which breaks up blood clots, won approval from the Food and Drug Administration for treating ischemic stroke, and it was expected to revolutionize the way stroke patients were treated.
A study by the National Institute of Neurological Disorders and Stroke found that stroke patients treated with T.P.A. were 30 percent more likely to have minimal or no disability three months later than those given a placebo.
Still, nearly five years later, the laissez- faire approach to stroke lingers in many emergency rooms. Only 2 percent to 3 percent of stroke patients actually receive the new drug, whereas 30 percent to 40 percent could benefit from it.
“You have to wonder why when a good drug became available, it wasn’t more rapidly used by physicians for this serious, otherwise untreatable, condition,” said Dr. John R. Marler, associate director for clinical trials at the stroke institute.
In part, it is because creating a change in attitude among doctors is often a slow process. But in this case, some doctors are reluctant to use T.P.A. because there is a risk that it will cause a life-threatening brain hemorrhage. In the stroke institute’s study, a hemorrhage occurred within 36 hours of the stroke in 6.4 percent of patients given T.P.A., compared with 0.6 percent of those given a placebo.
In addition, the drug’s three-hour window of safety and effectiveness presents a problem because most people do not get to the emergency room quickly enough to be examined and treated in time. After three hours, the worst of the brain damage has been done, and at that point the drug takes on a high risk of causing brain hemorrhage.
“The problem we have is that if you’re too late, or the diagnosis is wrong, or you don’t follow the protocol, the treatment may result in uncontrolled hemorrhage,” said Dr. J. P. Mohr, director of the stroke unit at New York Presbyterian Hospital.
“So it shouldn’t be too great a surprise that there’s a reluctance of physicians to take on a treatment that could result in disaster,” he said. “Mainly, the problem is fear on the part of the clinical team that their well-intended efforts can result in a disastrous lawsuit.”
The new drug has prompted the nation’s major stroke organizations and some politicians to try to increase awareness of stroke and to educate doctors and hospitals. They have even promoted a different name for a stroke, a “brain attack,” to imbue it with the same sense of urgency as a heart attack.
The National Stroke Foundation is starting a campaign aimed at women, who are less aware of stroke symptoms than men. Women account for 43 percent of strokes a year but take an average of 46 percent longer than men to get to hospitals and wait 49 percent longer to see doctors, a 1998 University of Texas study shows.
Congress just gave the Centers for Disease Control and Prevention $4.5 million to develop the Paul Coverdell National Acute Stroke Registry, named after the senator from Georgia who died of a stroke in July. The registry would track stroke patients.
Senator Edward M. Kennedy, Democrat of Massachusetts, is expected to introduce legislation calling for a grant program for states to develop systems of stroke care that would educate emergency medical workers in assessing stroke patients and would create standards of care for hospitals.
In June, the Brain Attack Coalition, a multidisciplinary group of experts, wrote an article in The Journal of the American Medical Association calling for more hospital stroke centers along the lines of those for trauma and burns.
The statement provides guidelines for those centers. The recommendations include having written stroke protocols, maintaining rapid response teams with neurologists, making computed tomography scans available 24 hours a day and directing emergency workers to take stroke patients to stroke centers rather than to other hospitals.
“Currently, only several dozen hospitals meet the definition of stroke centers as published in the article, and the number really has to increase to several hundred,” said Dr. Mark J. Alberts, director of the stroke unit at the Duke University Medical Center and the lead author of the article.
“Many of the changes deal more with public policy,” he said, “but it may be a more powerful approach than developing a new drug.”
The latest treatment clearly needs a learning curve. Last year, The Journal of the American Medical Association published two studies on the use of T.P.A. in hospital settings. One study looked at T.P.A. use nationwide in 57 hospitals whose staffs were experienced at using the drug; the other looked at 29 community hospitals in the Cleveland area where, in general, the staffs were less experienced.
The nationwide study of 389 patients found that the risk of symptomatic hemorrhage within 36 hours was 3 percent; the Cleveland study of 3,948 patients found a risk of 15.7 percent.
Researchers also found that in 50 percent of the cases, doctors in the Cleveland study did not follow treatment guidelines. For instance, they gave the drug too late or combined it with blood-thinning agents, putting the patient at greater risk of hemorrhage. Doctors in the nationwide study deviated from guidelines in 34.7 percent of cases.
Some experts found the results of the Cleveland study to be worrisome, raising the question of whether it is safe to get T.P.A. in hospitals with doctors who are inexperienced at using the drug. But others were encouraged by the results.
“I took great comfort in these trials,” Dr. Mohr of New York Presbyterian said. “They showed that a treatment exists, it can be used successfully, and the more experience you have using it, the more successful you’ll be.” He said he hoped the study would encourage more doctors to use the drug. But he warned that to minimize risk, doctors should be trained and experienced in giving T.P.A.
Perhaps the biggest deterrent to the use of T.P.A. is time. Much of the precious three hours is lost by patients themselves, who take too long getting to emergency rooms, largely because they do not recognize the symptoms of a stroke. According to a Gallup survey, 17 percent of adults over 50 cannot name any of the symptoms, which include numbness or weakness on one side of the body, confusion or trouble speaking, sudden vision problems, dizziness or loss of balance, or severe unexplained headache.
Some people delay going to the hospital by mistakenly calling their primary care doctors first and by waiting for the call back. Others do not bother to call 911; rather, they have a family member drive them to the hospital. But studies show that stroke patients who travel to the hospital by ambulance arrive sooner and are treated faster than those who travel by personal car.
Those who do get to the hospital quickly often face emergency department staffs that are unequipped to treat strokes as an emergency. Patients need to undergo a battery of tests to determine if they are having ischemic strokes and are otherwise candidates for T.P.A.; patients having hemorrhagic strokes can have fatal hemorrhages if treated with T.P.A. Ideally the work-up, which includes a brain scan, takes no longer than an hour.
But in emergency departments that do not have rapid response systems to deal with strokes (about 82 percent of hospitals do not), it often takes longer. In the Cleveland study, only 17 percent of patients with ischemic strokes were admitted for treatment within the three-hour window. And only 1.8 percent of patients received T.P.A.
Contributing to the problem, and possibly the incidence of strokes, is the similarly nonurgent way patients with transient ischemic attacks, or T.I.A., the so-called mini strokes, are treated. These ministrokes, caused by a temporary interruption of blood supply to the brain, typically bring on symptoms of stroke, but only for a few minutes. Traditionally, patients are sent home with aspirin and told to make an appointment in a week or two for follow-up testing.
But a new study, published in December in The Journal of the American Medical Association, found that 10.5 percent of people with ministrokes had full-blown strokes within 90 days of the T.I.A. and half of them had the strokes in two days.
“This is a much higher number than previously thought and may mandate a change in our approach,” said Dr. Alberts of Duke, suggesting that hospitals may need to begin admitting ministroke patients for immediate work-ups to identify those at risk for subsequent stroke.
While millions of dollars have been poured into research for drugs to treat stroke, most have failed in clinical trials. Some trials now under way are exploring ways to expand the treatment window from three hours to six. In these studies, doctors are injecting T.P.A. or other clot-busting drugs directly into the clogged artery, rather than through an intravenous line. This approach, however, is much riskier and is being used only for people with highly damaging strokes.
“The sort of public policy and education activities we’re seeing now are new and unique,” Dr. Alberts said.
“If you consider everything that’s been done with other major diseases, heart disease, cancer, H.I.V., for example,” he added, “stroke has been left in the lurch.”