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rFVIIa decreased hemorrhage volume growth
Though growth decreased, therapy did not improve survival, outcome.
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Recombinant activated factor VII reduced the growth of hematoma, but did not improve the survival or functional outcome after stroke-related intracerebral hemorrhage, according to new data published in The New England Journal of Medicine.
Results from a previous study found that rFVIIa improved survival and functional outcomes after intracerebral hemorrhage. To confirm these results, researchers from various sites in the United States, Europe and Australia conducted a phase-3 trial of 841 patients with intracerebral hemorrhage.
Within four hours after the onset of stroke, the patients were randomly assigned to placebo (n=268), 20 mcg rFVIIa per kg of body weight (n=276) or 80 mcg of rFVIIa per kg (n=297). The primary endpoints were severe disability or death within 90 days after stroke.
The growth of the volume of the hemorrhage decreased significantly in the 80 µg treatment group. After 24 hours, the mean estimated increase in the volume of the hemorrhage was 26% in the placebo group, 18% in the 20 mcg group (P=.09) and 11% in the 80 mcg group (P<.001).
Growth of hemorrhage was decreased by 2.6 mL (95% CI, –0.3-5.5) in the 20 mcg group, and by 3.8 mL (95% CI, 0.9- 6.7) in the 80 mcg group, compared with placebo. Despite these decreases, the number of patients with poor clinical outcomes did not differ significantly between the groups (24% for placebo, 26% for 20 mcg and 29% for 80 mcg).
Compared with placebo, the 80 mcg group had more arterial events (4% vs. 9%; P=.04), though the frequency of serious thromboembolic events was similar in all three groups. The researchers concluded that although the size of hematomas decreased rFVIIa did not improve survival or functional outcome. – by Stacey L. Adams
For more information:
- Mayer SA, Brun NC, Begtrup K et al. Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2008;358:2127-2137.