Can a Subset of Intracerebral Hemorrhage Patients Benefit From Hemostatic Therapy With Recombinant Activated Factor VII

Published on Mar 1, 2009in Stroke6.058
· DOI :10.1161/STROKEAHA.108.524470
Stephan A. Mayer71
Estimated H-index: 71
Stephen M. Davis Mpa Msw94
Estimated H-index: 94
+ 5 AuthorsThorsten Steiner48
Estimated H-index: 48
Background and Purpose— In the Factor Seven for Acute Hemorrhagic Stroke (FAST) trial, 80 μg/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. Methods— Using the FAST data set, the impact of rFVIIa (80 μg/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. Results— A subgroup (n=160, 19% of the FAST population) was identi...
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