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You have ?? Hours to get Treatment after a Stroke - Update
Posted: Wednesday, June 10, 2009
Intravenous clot-busting therapy with tissue plasminogen activator (tPA) should be administered up to 4.5 hours from stroke onset in eligible patients, according to a science advisory from the American Heart Association/American Stroke Association.
The recommendation revises 2007 guidelines stating that tPA should be started only within the first three hours after symptom onset. The new guidance, based on the results of two recent large studies, was reported online in Stroke: Journal of the American Heart Association.
However, the advisory committee, led by Gregory del Zoppo, M.D., of the University of Washington in Seattle, reinforced the importance of initiating treatment as early as possible.
"Although a longer time window for treatment with recombinant tPA has been tested formally," they said, "delays in evaluation and initiation of therapy should be avoided, because the opportunity for improvement is greater with earlier treatment."
Jeffrey Saver, M.D., of the University of California Los Angeles, a member of the advisory panel and incoming chair of the AHA's Stroke Council, added, "Time lost is brain lost in acute stroke, and every ten minutes that goes by without treatment, one fewer patient benefits from therapy."
The 2007 guidelines have had limited impact: most patients with ischemic stroke do not receive thrombolytic therapy because they arrive at the emergency room outside the three-hour window.
To explore the possibility of increasing the number of patients receiving tPA, studies have looked at outcomes in those receiving the treatment up to 90 minutes beyond the recommended window.
The Safe Implementation of Thrombolysis in Stroke (SITS) study not only confirmed the safety of the three-hour window, but also suggested a benefit up to four-and-a-half hours after symptoms appear.
Although Dr. del Zoppo and colleagues said there were several weaknesses in that study, there were no differences in symptomatic intracerebral hemorrhage, mortality, or disability at 90 days between patients who received treatment within three hours and those who received treatment up to 90 minutes later.
The safety and efficacy of the extended window received more support from the European Cooperative Acute Stroke Study (ECASS)-3, which compared tPA with placebo in the extended window.
Thrombolytic therapy reduced disability, the primary endpoint. It also resulted in more symptomatic cerebral bleeding, although mortality was not affected.
The results show that tPA can be given safely to "carefully selected patients" in the extended window, according to the members of the writing committee.
The trial excluded patients older than 80, those who had suffered a severe stroke, those who had a combined history of stroke and diabetes, and those taking anticoagulants. These patients would not be eligible for treatment in the extended window, the authors said.
"These recommendations, which are based on peer-reviewed publications, should be re-evaluated after the results of regulatory agency review of detailed, nonpublicly available data are known," they said.
"The level of evidence currently is strong, but not absolute," Dr. Saver said. "So we do think that it would be helpful to have further information, including additional analyses of the most recent trial, the ECASS-3 trial ... as well as, possibly, additional studies to confirm the benefit."
Explain to interested patients that 2007 guidelines recommended administering intravenous tPA no more than three hours after symptom onset in patients with ischemic stroke.
Point out that this science advisory lengthens that timeframe to 4.5 hours.
Source: Diabetes In Control: del Zoppo G, et al "Expansion of the time window for treatment of acute ischemic stroke with intravenous tissue plasminogen activator: a science advisory from the American Heart Association/American Stroke Association" Stroke 2009; DOI: 10.1161/STROKEAHA.109.192535.
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