NEW ORLEANS– A decade after hospitals began using the first approved drug treatment for stroke, relatively few patients benefit from it.
Most still don t get to the hospital in time. But use of the clot-buster tPA also continues to be weighed down by debate over its benefit and safety.
A recent study led by the University of Michigan underscores the underwhelming number of patients who receive tPA. Seven of 10 patients did not make it to the hospital in time to receive the medicine, according to the five-year study conducted in Corpus Christi, Texas. The drug is to be used only within three hours after symptoms begin.
The fact that most stroke victims arrive too late has been well-established. Used since the 1980s to treat heart attacks, tPA was approved in 1996 to treat ischemic strokes, the most common type. Ischemic strokes happen when a blood clot chokes off circulation to part of the brain.
TPA, which is given through an IV, can restore blood flow and improve the chances of escaping disability. But it also elevates risk of fatal brain hemorrhages. Forty percent of emergency doctors said they were unlikely to give the drug because of the risk, according to a University of Michigan study two years ago.
About 700,000 strokes occur every year in the United States, making it a leading cause of death and disability. When ischemic stroke happens, a person may feel sudden numbness in a hand or leg, or have trouble speaking or seeing.
Doctors say these symptoms should be regarded as an emergency. But patients sometimes don t recognize the warning signs or they wait, hoping the problems will subside.
Educating the public that stroke symptoms are an emergency has been a thrust of efforts to boost tPA usage.
Across the board in the United States, we could do a better job getting patients inside that three-hour window, said Dr. Irene Katzan, director of the Stroke Outcomes Research Program, a collaboration of Cleveland s big hospitals.
The push is also to get patients to the right hospitals. Patients fare better at hospitals designated as primary stroke centers, stroke experts say.
The Joint Commission, a national hospital accrediting group, lists seven primary stroke centers in the Cleveland-Akron area.
But there is no system in place to get all stroke patients to these hospitals, or agreement on whether hospitals not designated as stroke centers should administer tPA.
Stroke centers must meet a host of national guidelines involving timing of diagnosis and treatment and providing 24-hour expertise in cerebrovascular disease and brain imaging.
Specialists say these programs minimize risks and are the answer to reluctance among some doctors to use tPA.
I don t see emergency departments resistant to the thought of it, said Katzan. Some EDs don t have the system in place to properly manage it.
Although the percentage of ischemic stroke patients who get tPA appears to be inching up, only about 5 percent receive the drug, according to various estimates published by the American Stroke Association. Many who do arrive at the hospital in time are excluded because they take blood thinners or have other medical conditions making them ineligible.
The question of where a patient should be treated is complicated. It depends not just on a hospital s capabilities, but also on the severity of stroke, how much time has passed and proximity to a primary stroke center.
Dr. Daniel Walsh, chairman of emergency medicine at EMH Regional Healthcare System in Ohio s Lorain County, said emergency medical services don t steer stroke patients to particular hospitals.
The Elyria hospital administers tPA in some cases, but patients with severe strokes are flown from there to primary stroke centers in Cuyahoga County, he said.
Specialists at stroke centers say the benefits of tPA outweigh the risks for carefully selected patients.
It absolutely improves outcomes, said Dr. Michael DeGeorgia, director of neuro-intensive care at University Hospitals Case Medical Center. There s no question that it helps. It helps better the earlier you get it.
But Walsh and other emergency physicians have not shared the enthusiasm.
Professional groups representing emergency doctors have declined to endorse tPA as a standard of care.
The American Academy of Emergency Medicine issued a statement raising safety concerns and questioning a landmark government study that led to approval of tPA for strokes.
A 2006 article in the online medical journal Stroke referred to tPA as a medicolegal quagmire, noting that doctors are at increased risk of being sued whether they elect to use or not to use tPA.
Walsh said considering the risks of bleeding in the brain and that a third of stroke patients recover on their own, emergency doctors are apprehensive about giving tPA.
That s unusual in emergency medicine, he said. Give us a new tool . . . we re usually the first to use it. It attests to the first do no harm axiom that we all ascribe to.
Dr. Carol Cunningham, EMS medical director for Lake Hospital System, said liability concerns prompted her medical group to decide to transfer most stroke patients to primary stroke hospitals. What physicians do is what your malpractice carrier allows you to do, Cunningham said.
Despite differences over tPA, doctors agree the people need to get to the hospital fast when symptoms appear.Harlan Spector is a reporter for The Plain Dealer of Cleveland. He can be contacted at [email protected]