ESOC 2026 | Analysis of the FASTEST trial: baseline CT markers predict response to rFVIIa in ICH

The first thing about the abstract is remember the context. So in February, we presented data that was published in The Lancet that looked at these determinants, the baseline determinants that predicted who would have the most response to factor VIIa. And the two things that came out were treatment with patients who had a spot sign, which is a sign of extravasation of contrast dye within the blood bleeding. And the other was treatment within 90 minutes. And that showed that we could also decrease the growth, but also maybe improve outcome. What we also did, which we’re presenting for the first time, is look at the baseline scans and determine if hypodensity could also be a predictor of response to factor VIIa. Now, like spot sign, hypodensity has been associated with increased risk of expanding of the intracerebral hemorrhage and also with a worse outcome. And so our hypothesis was that patients who had a baseline scan that showed an area of hypodensity in the body of the hemorrhage would be, first of all, more likely to have a poor outcome, but also may be more likely to have a response to factor VIIa in terms of stopping growth and also in terms of outcome, better outcome. Now, so the first thing we found when we looked at the hypodensity group is that it indeed was associated with a much larger amount of hemorrhage to start with, and it was also associated with a much worse outcome. So, for example, if you had a hypodense area in the center of the hemorrhage, you had about a 27% chance that you’d be functionally independent within 180 days versus 49% if you didn’t have hypodensity. And some of that’s just because they were bigger hemorrhages, a lot bigger hemorrhages. So that’s the first thing we saw. So then the question was, well, will this hypodensity also be a marker for how factor VIIa could slow growth and also would it also improve outcome? And what we didn’t find was that it was any kind of relationship with just hypodensity by itself with slowing of the growth or with improved outcome as compared to not having a hypodense area. And remember, everybody was treated within two hours of onset. Then we, though, said, well, what happens if we put the two markers together? So then we looked at patients, not just because of their baseline hypodensity area, if they had one or not, but also if they had a spot sign. And what we found is that if you have a hypodense area and a spot sign together, that’s the group that had the largest difference in terms of response to factor VIIa in terms of stopping growth and also the best outcome at 180 days and 90 days. And if you had neither of those findings, you didn’t really have any response to growth or to improved outcome. The spot sign still was better than the hypodensity by itself, but was not significant by itself. So I think what we found is we found this subgroup of people who have the greatest likelihood of having expanding intracerebral hemorrhage, which is associated with worse outcome, but that also is the group that can benefit most from a hemostatic agent, like we found with the factor VIIa.

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