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Title: Thrombolytic Therapy For Stroke Effective

"Thrombolytic Therapy For Stroke Effective"

CHICAGO, IL -- February 29, 2000 -- Some but not all patients who experience an ischemic stroke (a stroke caused by a blocked blood vessel) can achieve favorable outcomes when treated with tissue-type plasminogen activator (tPA), according to two articles in the March 1 issue of The Journal of the American Medical Association (JAMA). In one study, Gregory W. Albers, M.D., from Stanford University Medical Center in Palo Alto, Calif., and colleagues studied 389 patients who had experienced acute ischemic stroke who were participating in the Standard Treatment with Alteplase to Reverse Stroke (STARS) study to evaluate the patient outcomes after treatment with intravenous tPA. TPA is a thrombolytic treatment (a treatment used to dissolve blood clots). The researchers measured outcomes from patients who had experienced acute stroke and were treated with intravenous tPA at 57 medical centers in the United States between February 1997 and December 1998. The researchers found that 35 percent of patients had "very favorable" outcomes and 43 percent were "functionally independent" based on modified Rankin scores (a scale used to measure how well the patient is functioning after a stroke) 30 days after treatment. Based on the same scale, 12 percent of the patients had moderate disability and 31 percent had moderate-to-severe or severe disability. Symptomatic intracerebral hemorrhage (bleeding in the brain) occurred in 3.3 percent (13) of the patients within 3 days of treatment with tPA-seven of these patients died. Asymptomatic intracerebral hemorrhage occurred in 8.2 percent of the patients within 3 days of treatment. Major systemic bleeding occurred in 1.5 percent of patients. The overall mortality rate for the study was 13 percent at 30 days. "The STARS study is the largest prospective, monitored, post-approval trial with intravenous tPA for treatment of acute ischemic stroke," according to the authors. "The results of this study suggest that favorable outcomes and low rates of symptomatic ICH [intracerebral hemorrhage] can be achieved in clinical practice at multiple medical centers across the United States." However, the authors also point out that 37 percent of patients had treatment that represented violations of the protocol for tPA administration. According to background information cited in the study, "Tissue-type plasminogen activator (tPA) is the only medication approved for treatment of acute ischemic stroke. This therapy was approved by the Food and Drug Administration in June 1996 for selected patients who can be treated within three hours of stroke onset." Citing previous studies the authors write, "Only a small fraction of eligible stroke patients currently receive tPA therapy. One of the greatest concerns regarding the use of tPA for stroke treatment is the belief that the risk of symptomatic ICH may be higher in routine clinical use than it was in the NINDS [National Institute of Neurological Disorders and Stroke]-sponsored research study." (JAMA. 2000;283:1145-1150) Related Link: [The Journal of the American Medical Association (JAMA).

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