Findings from the reanalysis of the NINDS tissue plasminogen activator for acute ischemic stroke treatment trial

Timothy John Ingall, William Michael O'Fallon, Kjell Asplund, Lewis Robert Goldfrank, Vicki S. Hertzberg, Thomas Arthur Louis, Teresa J. Hengy Christianson

Research output: Contribution to journalArticle

Abstract

Background and Purpose - Following publication of concerns about the results of the National Institute of Neurological Disorders and Stroke (NINDS) intravenous tissue plasminogen activator (t-PA) in acute stroke treatment trial, NINDS commissioned an independent committee "to address whether there is concern that eligible stroke patients may not benefit from t-PA given according to the protocol used in the trials and, whether the subgroup imbalance (in baseline stroke severity) invalidates the entire trial." Methods - The original NINDS trial data were reanalyzed to assess the t-PA treatment effect, the effect of the baseline imbalance in stroke severity between the treatment groups on the t-PA treatment effect, and whether subgroups of patients did not benefit from receiving t-PA. Results - A clinically important and statistically significant benefit of t-PA therapy was identified despite subgroup imbalances in baseline stroke severity and an increased incidence of symptomatic intracerebral hemorrhage in t-PA treated patients. The adjusted t-PA to placebo odds ratio (OR) of a favorable outcome was 2.1 (95% CI, 1.5 to 2.9). Although these exploratory analyses found no statistical evidence that the t-PA treatment effect differed among patient subgroups, the study was not powered to detect subgroup treatment differences. Conclusions - These findings support the use of t-PA to treat patients with acute ischemic stroke within 3 hours of onset under the NINDS t-PA trial protocol. Health professionals should work collaboratively to develop guidelines to ensure appropriate use of t-PA in acute ischemic stroke patients.

Original languageEnglish (US)
Pages (from-to)2418-2424
Number of pages7
JournalStroke
Volume35
Issue number10
DOIs
StatePublished - Oct 1 2004

Keywords

  • Randomized controlled trials
  • Stroke, acute
  • Tissue plasminogen activator

ASJC Scopus subject areas

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

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    Ingall, T. J., O'Fallon, W. M., Asplund, K., Goldfrank, L. R., Hertzberg, V. S., Louis, T. A., & Hengy Christianson, T. J. (2004). Findings from the reanalysis of the NINDS tissue plasminogen activator for acute ischemic stroke treatment trial. Stroke, 35(10), 2418-2424. https://doi.org/10.1161/01.STR.0000140891.70547.56