Transition of European Cooperative Acute Stroke Study III Results to Clinical Practice
Ninety-Day Outcomes in a US Cohort
Background and Purpose—The European Cooperative Acute Stroke Study (ECASS) III showed benefit of intravenous tissue-type plasminogen activator for acute ischemic stroke 3 to 4.5 hours from onset in selected patients from Europe, with this extended treatment subsequently recommended by the American Stroke Association. We prospectively enrolled patients with acute ischemic stroke treated with intravenous tissue-type plasminogen activator, during the time this recommendation was being applied in clinical practice to determine safety and efficacy in a representative cohort from the United States.
Methods—Patients with acute ischemic stroke treated with intravenous tissue-type plasminogen activator were enrolled at 18 primary stroke centers throughout Maryland, including community hospitals and academic medical centers. Patients grouped by time to treatment (≤3 versus 3–4.5 hours) were compared for the presence of exclusion criteria from ECASS III that are not standard practice in the United States for ≤3 hours (age, >80 years; history of stroke and diabetes mellitus; oral anticoagulant treatment; and National Institutes of Health Stroke Scale, >25). Outcomes included good function at 90 days (modified Rankin Scale, 0–1 and 0–2), mortality, and symptomatic intracerebral hemorrhage.
Results—In the 3- to 4.5-hour treatment group, there were significantly fewer patients aged >80 years and no patients with the combination of stroke and diabetes mellitus. There were no statistically significant differences by time to treatment in symptomatic intracerebral hemorrhage, mortality, or functional outcome.
Conclusions—For patients treated with intravenous tissue-type plasminogen activator 3 to 4.5 hours from onset in everyday practice in the United States, there is no evidence for increased risk or worse outcomes compared with standard treatment ≤3 hours.
- Received June 12, 2013.
- Accepted August 28, 2013.
- © 2013 American Heart Association, Inc.