Questioning Medicine

1° outcome: hemostatic efficacy = which was defined as;(A) Hematoma expansion ≤ 35% at 12h(B) increase in NIHSS ≤ 7 at 12h(C) No rescue therapy 3-12h    Results hemostatic efficacy: 76.7% andexanet vs 64.6% usual care    30 day mortality: no difference30 day Modified Rankin Score ≤3: no differenceThrombotic events: almost x2 with andexanet 10.3% vs 5.6% - statistically significant. Most were strokes and MI - not trivial. The question you should ask: How does effective is hemostatic efficacy as a marker for patient outcomes?? Yes, we don’t want the brain bleed to get bigger but patients don’t care if the bleed gets bigger if they still die or if they still are in a coma for the rest of their life. We know from warfarin that increase in hematoma expansion leads to worse outcomes (https://pubmed.ncbi.nlm.nih.gov/21346218/). We don’t have clear data on this for the DOACs. HOWEVER, just because an expanding hematoma leads to a bad outcome that does not mean that giving a medication to decrease hematoma expansion l