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Expanding the Window for Acute Stroke Treatment

New recommendations from the American Heart Association/American Stroke Association on using t-PA between 3 and 4.5 hours after stroke onset

Recombinant tissue plasminogen activator (t-PA) is FDA-approved for the treatment of acute ischemic stroke within 3 hours after symptom onset. A recent randomized, controlled trial (ECASS 3) demonstrated that intravenous t-PA is safe and effective in patients treated between 3.0 and 4.5 hours after symptom onset (N Engl J Med 2008; 359:1317). Primarily on the basis of this finding, the American Heart Association/American Stroke Association has now issued revised treatment guidelines for acute ischemic stroke that recommend t-PA use up to 4.5 hours after symptom onset.

The guideline authors note that patients eligible for treatment within 3 hours should still be treated according to the AHA/ASA 2007 guidelines. For patients treated between 3.0 and 4.5 hours, eligibility criteria for t-PA treatment are similar to those for patients treated within 3 hours, with four additional exclusion criteria: age >80, oral anticoagulant use (regardless of international normalized ratio), baseline NIH Stroke Scale score >25, or history of both diabetes and prior stroke. The guidelines emphasize avoiding delays in treatment, because the odds of a favorable outcome decline over time.

Comment: Intra-arterial t-PA and mechanical thrombolysis have already expanded treatment windows for stroke patients; however, these treatment modalities are available only at specialized, comprehensive stroke centers. Expanding the intravenous t-PA window will potentially allow more patients to access acute therapy at hospitals without these resources. However, the mantra "Time is Brain" resounds. A door-to-needle time of 60 minutes or less remains a critical benchmark, as, again, it must be emphasized that earlier treatment improves outcomes. Many physicians have been aware of the ECASS 3 results for months but have been waiting for an authoritative body in the U.S. to weigh in before adapting their clinical practice. The AHA/ASA guidelines should help overcome the inertia.

— James S. McKinney, MD

Dr. McKinney is Assistant Professor, Department of Neurology, University of Medicine and Dentistry of New Jersey – Robert Wood Johnson Medical School, Piscataway; and Medical Director, Robert Wood Johnson University Hospital Comprehensive Stroke Center, New Brunswick, NJ.

Published in Journal Watch Neurology October 6, 2009

Citation(s):

del Zoppo GJ 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 Aug; 40:2945.

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