• Stephan A Mayer, Stephen M Davis, Brett E Skolnick, Nikolai C Brun, Kamilla Begtrup, Joseph P Broderick, Michael N Diringer, Thorsten Steiner, and FAST trial investigators.
• Department of Neurology and Neurosurgery, Columbia University, New York, NY, USA. sam14@columbia.edu
• Stroke. 2009 Mar 1;40(3):833-40.

Background And PurposeIn the Factor Seven for Acute Hemorrhagic Stroke (FAST) trial, 80 microg/kg of recombinant activated factor VII (rFVIIa) significantly reduced intracerebral hemorrhage (ICH) expansion when given within 4 hours of onset. However, in contrast to an earlier Phase 2b study, rFVIIa did not improve survival or functional outcome. In this exploratory analysis, we hypothesized that earlier treatment and exclusion of patients with a poor prognosis at baseline might enhance the benefit of rFVIIa treatment.MethodsUsing the FAST data set, the impact of rFVIIa (80 microg/kg) on poor outcome at 3 months (modified Rankin Score of 5 or 6) was systematically evaluated within subgroups using clinically meaningful cut points in onset-to-treatment time, age, and baseline ICH and intraventricular hemorrhage volume. The effect of treatment on outcome was analyzed using logistic regression, and ICH volume was analyzed with linear mixed models.ResultsA subgroup (n=160, 19% of the FAST population) was identified comprising patients ConclusionsA prospective trial would be needed to determine whether younger patients with ICH without extensive bleeding at baseline can benefit from 80 mug/kg of rFVIIa given within 2.5 hours of symptom onset.

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