The other day, I summarised the new data on thrombotic events with andexanet alfa, presented to/by the FDA. Now, let's focus on new efficacy data A🧵 - ThreadSky

richardbuka.bsky.social • 90 days ago

The other day, I summarised the new data on thrombotic events with andexanet alfa, presented to/by the FDA.

Now, let's focus on new efficacy data

A🧵

Reposted from Richard Buka

Tons of NEW DATA about andexanet, presented as part of FDA hearing last week. If you couldn’t make it through the short 6h meeting, GOOD NEWS, I’ve watched it and highlighted the important points.
A🧵

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richardbuka.bsky.social•90 days ago

First AZ presented (mostly) published trial data. Andexanet showed significant improvement in all parameters making up haemostatic efficacy but the only significant component was haematoma expansion. The visual representation is quite useful but nothing new here.

richardbuka.bsky.social•90 days ago

Data not new but Kaplan Meier is useful. All cause mortality: 28% vs 26%, death due to index bleeding event: 5% vs 7%
Many point out that 30 days is too short to look for survival effects of acute interventions but this is all we have to go on.

richardbuka.bsky.social•90 days ago

There were +++ comments about hematoma expansion being strongly correlated with outcomes. Often quoted is the statistic: every 1 mL expansion corresponds to a 5% increased risk of death/dependency at 90 days.

richardbuka.bsky.social•90 days ago

This is based on Delcourt et al. 2012 – a subanalysis of the INTERACT1 study - so these are hypertensive patients who are not anticoagulated. In this study, haematoma expansion was measured at 24h rather than 12.

richardbuka.bsky.social•90 days ago

So, whilst I agree that expansion is correlated with outcomes, it's not linear. Also, ANNEXA-I uses % change rather than absolute. There are issues relating to bleed volume etc... that I won't go into but long story short the stat above is a simplification.

richardbuka.bsky.social•90 days ago

In the published paper, there was no difference in mRS at 30 days. Next, we see some interesting data in the FDA (n=404) dataset. This analysis looks only at patients who those who were responders (patients with <35% haematoma expansion at 30 days).

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