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| |  ANA: Tissue Plasminogen Activator Safe for Ischemic Stroke, Literature Review Finds By Thomas S. May Special to DG News NEW YORK, NY -- October 15, 2002 -- Tissue Plasminogen Activator (tPA) is safe and effective for acute ischaemic stroke, especially when established guidelines are followed, a meta-analysis of 13 published studies shows. "This is the first meta-analysis of the reported open-label clinical experience with IV tPA for acute ischemic stroke," said Dr. Glenn David Graham, director of the Cerebrovascular Disorders Program at University of New Mexico School of Medicine, Albuquerque, NM, USA, who presented the findings here October 14, at the 127th annual meeting of the American Neurological Association (ANA). Although tissue plasminogen activator (tPA) has been approved in the United States for treatment of ischemic stroke with a three-hour window for more than 5 years, concerns regarding the safety of tPA when used in a variety of clinical settings remain. In an effort to evaluate the safety of tPA in stroke patients, Dr. Graham analysed 13 studies (10 of them prospective), incorporating a total of 2,529 patients. Data from the large Canadian Activase for Stroke Effectiveness Study (CASES), currently available only in abstract form, were also included. Reports limited to special populations (e.g., the elderly) and series of less than 25 patients were not included. The overall symptomatic intracerebral haemorrhage (S-ICH) rate was 5.1 percent, slightly lower that the 6.4 percent rate in the treated group of the National Institute of Neurological Disorders and Stroke (NINDS) trial. Mean total death rate (12.9 percent) and the proportion of subjects achieving a very favourable outcome (modified Rankin score 0 or 1, 36.7 percent) were comparable to the NINDS results. Protocol deviations were reported in 19 percent of the studies included. A strong trend for correlation of protocol violation and S-ICH rates was noted (r=0.57; p=0.052). These data support the safety of tPA in acute ischemic stroke, especially when established guidelines are followed, Dr. Graham suggested. "The tendency for protocol violations to be associated with higher symptomatic ICH rates emphasises the importance of adherence to established treatment guidelines," he added. "Given the lingering controversy regarding tPA use in acute stroke, these results should be of interest to practising neurologists and others involved in acute stroke care, such as emergency medicine specialists," he concluded.
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