1/ FDA hearing on #andexanet alfa is tomorrow (21 Nov 2024). The documents contain some more data on thrombotic events that weren't published in ANNEXA-I.

To be honest, reading through, I have found this data pretty shocking.

A 🧵 The ANNEXA-I trial enrolled 530 patients with intracranial (mainly intracerebral) haemorrhage and randomised them to andexanet alfa or usual care. Showed improved haemostatic efficacy, driven by ⬇️ number of patients with haematoma expansion of >35% 12 hours after treatment.

1/ Right, ANNEXA-I has dropped. The 1st ever RCT of a reversal agent for DOACs. Randomised patients with intracranial hemorrhage to andexanet alfa or usual care. Stopped early as it met its primary endpoint.
There are A LOT of talking points - LET'S GO! nejm.org/doi/full/10.10… 2/ Want to skip the results and go straight to critique? Go to tweet 9.
Total enrolment 530 but efficacy analysis based on 452. Safety analysed in all 530. Efficacy analysis of 530 is in supplemental and is NOT different to the main analysis.

1/ Is targeting thrombosis without affecting haemostasis possible? A🧵 2/ Every treatment for thrombotic conditions comes at a price – a risk of bleeding. With DOACs, the risk of major bleeding is 3-7% per year. Holy grail is to find therapies that treat thrombosis w/o bleeding. Is this possible or just a pipe dream? Let’s look at recent progress.

It's world breastfeeding week! #WBW2022
As a haematologist, the most common involvement in breastfeeding is with post-partum anticoagulation advice. DOACs have revolutionised treatment of thrombosis but @ISTH recommend they are avoided in breastfeeding. 1/ But...
I wonder whether this is sometimes interpreted differently. Is it instead interpreted as:
"Breastfeeding is best avoided on DOACs"?
I wonder... are women are put off, or worse - are HCPs advising not to breastfeed so DOAC can be used, avoiding warfarin or injections? 2/