Study Questions Combo Therapy for Stroke Patients

Using aspirin with anti-clotting medication increases risk of bleeding problems

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HealthDay Reporter

FRIDAY, July 23, 2004 (HealthDayNews) -- Using aspirin with a clot-preventing drug for people at high risk of artery problems after a stroke does slightly more harm than good, a new international study finds.

"It has a small benefit in terms of reducing the risk of another stroke, myocardial infarction [heart attack] or death, but there is a significant increase in bleeding complications," said Dr. Hans-Christopher Diener, a professor of neurology at the University of Essen, Germany.

Diener is lead author of a report on the study, which appears in the July 24 issue of The Lancet.

Combining aspirin with the anti-clotting drug clopidogrel (Plavix) is "much more common in the United States than in Europe," Diener said.

The study results "should cause physicians to reexamine the practice of using the combination routinely," said Dr. Mark J. Alberts, a professor of neurology at Northwestern University Medical School, who took part in the study and is a spokesman for the American Heart Association.

But use of the combined therapy to prevent strokes or other clot-related problems for such patients should not be ruled out completely, Alberts said.

The clopidogrel-aspirin combination has been shown to benefit people at high risk of a heart attack and other heart-related problems because of a previous heart attack. Analysis of the study findings might find subgroups of patients in whom the therapy can reduce the risk of second strokes, he said.

"With over 7,000 patients in the study, it is possible to find such subgroups," Alberts said.

The study included patients who had suffered either a recent stroke caused by a blood clot or a transient ischemic attack, in which a clot temporarily blocks a blood vessel. All had already been prescribed clopidogrel. In the study, half were also given aspirin, which thins the blood, in addition to the anti-clotting drug.

After 18 months, the incidence of stroke, heart attack, hospitalization for a clotting problem or death was slightly lower for those getting the combined therapy -- 15.7 percent in the clopidogrel-aspirin group, compared to 16.7 percent in the clopidogrel-only group.

But the incidence of life-threatening bleeding was higher for those getting the combined treatment (2.6 percent) than in those getting clopidogrel alone (1.3 percent).

"If you compare the good results with the bad results, it is more or less a wash," Alberts said.

But, Alberts added, "a physician needs to exercise clinical judgment" before ruling out the combination for a given patient. "We need to look at the fact that our clinical options are very limited," he said. "If you have a patient who fails to benefit from single-agent therapy, the clinician has to consider a combination."

The researchers will be combing through the study data to find patients who might benefit from the combined treatment. For example, they will compare patients where the initial problem was caused by a clot in a large artery to those who suffered a small-artery clot.

More information

To learn more about stroke, visit the American Stroke Association.

SOURCES: Hans-Christopher Diener, M.D., professor, neurology, University of Essen, Germany; Mark J. Alberts, M.D., professor, neurology, Northwestern Unversity Medical School, Chicago; July 24, 2004, The Lancet

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