Adherence to Third European Cooperative Acute Stroke Study 3- to 4.5-hour exclusions and association with outcome:

Carolyn A Cronin1, Kevin N Sheth1, Xin Zhao1

  • 1From the Department of Neurology, University of Maryland School of Medicine, Baltimore (C.A.C.); Department of Neurology, Yale School of Medicine, New Haven, CT (K.N.S.); Duke Clinical Research Institute, Durham, NC (X.Z., A.F.H.); Department of Neurology, Hospital of the University of Pennsylvania, Philadelphia (S.R.M.); Department of Neurology, University of Texas Southwestern, Dallas (D.M.O.); Department of Cardiology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (D.L.B.); Department of Neurology, Institute for Heart, Vascular and Stroke Care, Massachusetts General Hospital, Boston and Harvard Medical School, MA (L.H.S.); and Department of Clinical Neurosciences and Hotchkiss Brain Institute, University of Calgary, Calgary, Canada (E.E.S.).

Stroke
|August 9, 2014
PubMed

Insights

Many patients treated with tissue-type plasminogen activator (tPA) beyond 3 hours have specific exclusion criteria. However, these additional criteria did not worsen outcomes compared to earlier treatment.

Area of Science:

  • Neurology
  • Cardiovascular Medicine
  • Emergency Medicine

Background:

  • Current guidelines recommend intravenous tissue-type plasminogen activator (tPA) for ischemic stroke within 3 to 4.5 hours, based on ECASS III criteria.
  • ECASS III included specific exclusions beyond standard criteria: age >80, prior stroke, diabetes mellitus, oral anticoagulant use, and NIH Stroke Scale >25.

Purpose of the Study:

  • To assess adherence to ECASS III-specific exclusion criteria in patients treated with tPA between 3 to 4.5 hours from symptom onset.
  • To determine the association of these exclusion criteria with patient outcomes.

Main Methods:

  • Analysis of Get With The Guidelines-Stroke data from 32,019 ischemic stroke patients treated with tPA within 4.5 hours.
  • Comparison of the prevalence of ECASS III exclusion criteria between the 0-3 hour and 3-4.5 hour treatment windows.
  • Evaluation of the risk of symptomatic intracranial hemorrhage and hospital outcomes based on exclusion criteria.

Main Results:

  • 31.5% of patients treated with tPA between 3 to 4.5 hours met at least one ECASS III exclusion criterion, most commonly age >80.
  • Exclusion criteria were generally less prevalent in the 3-4.5 hour window compared to the 0-3 hour window, except for prior stroke and diabetes.
  • No increased risk of symptomatic intracranial hemorrhage or worse hospital outcomes was observed for patients treated in the 3-4.5 hour window, even with additional exclusion criteria.

Conclusions:

  • A significant proportion of patients treated with tPA in the 3-4.5 hour window have ECASS III-specific exclusion criteria.
  • The presence of these additional exclusion criteria did not negatively impact outcomes when tPA was administered between 3 to 4.5 hours compared to 0-3 hours.
Abstract