2) Our returning expert author is #ANNEXa_I investigator Ashkan Shoamanesh MD @Ash_Shoamanesh, #Stroke #Neurologist @HamHealthSci, Assoc Prof @McMasterU, & Director of Hemorrhagic Stroke Research Program & Scientist @PHRIresearch #FOAMed #FOAMcc #neurotwitter #cardiotwitter pic.twitter.com/FXhn7lNBt4
— cardio-met (@cardiomet_CE) February 8, 2024
4) Remember when we brought you the #ANNEXa_I top-line results from #WSC23? Go back and (re)check that #tweetorial, and still earn more 🆓CE/#CME, at https://t.co/bQ4qvD5Dzb.#MedEd @MedTweetorials
— cardio-met (@cardiomet_CE) February 8, 2024
All of this amazing education is intended for #healthcare providers! pic.twitter.com/5f8d2tz6ss
5b) Patients were randomly assigned to receive either #andexanet or usual care, within 2h of the qualifying #scan.
— cardio-met (@cardiomet_CE) February 8, 2024
👉Keep in mind that the only reversal agent authorized by @US_FDA to date for pts with anti-#FXa–#DOAC associated major or life-threatening 🩸is andexanet. pic.twitter.com/y5RVmwsRJv
5d) As #ANNEXa_4 (🔓https://t.co/T8UrNqqfgY), the trial that ➡️ authorization, was an open-label, single-cohort (#andexanet) study, a randomized study was needed to further explore its safety & efficacy. As there is no other approved tx, comparison was made to "usual care."
— cardio-met (@cardiomet_CE) February 8, 2024
6b) Following a planned interim assessment of efficacy (n=450), an independent #DSMB concluded that #andexanet showed superior hemostatic efficacy after 1mo f/u vs usual care, and stopped the trial early.
— cardio-met (@cardiomet_CE) February 8, 2024
Hence the #LBCT at #WSC2023. The full analysis has not yet been published.
8a) The median baseline #hematoma volume was ~10cc, which is consistent with that reported in hospital cohorts of anti-#FXa–#DOAC associated #ICH. Baseline median #NIHSS was 9⃣.
— cardio-met (@cardiomet_CE) February 8, 2024
9) 🛑🩸Primary outcome: excellent or good #hemostatic efficacy occurred more often w/andexanet (64%) vs usual care (54%).
— cardio-met (@cardiomet_CE) February 8, 2024
👉This ➡️11 more excellent/good hemostatic efficacy outcomes /100 pts tx'd w/#andexanet.
👉Benefit driven mostly by ⬆️ rates of excellent hemostasis.
11) That “hematoma increase” of 12.5cc, or 35% expansion, was the focus of this first, important secondary analysis, which @Ash_Shoamanesh presented today at #ISC24. pic.twitter.com/mV07JZekYz
— cardio-met (@cardiomet_CE) February 8, 2024
13a) So in THIS analysis, the primary outcome was #hematoma #expansion #HE and the factors that contributed to more of it, evaluating two potentially predictive models which are based on known predictors from the literature of HE: pic.twitter.com/sHsYHDQiut
— cardio-met (@cardiomet_CE) February 8, 2024
14) And here's the population from #ANNEXa_I that was studied: pic.twitter.com/SL25R2AKv6
— cardio-met (@cardiomet_CE) February 8, 2024
15b) Shorter symptom onset-to-treatment time, larger baseline #ICH volume, and higher pre-scan baseline #hematoma growth rate were associated with #HE in the adjusted models. pic.twitter.com/ppPXwRurRn
— cardio-met (@cardiomet_CE) February 8, 2024
16) The NNT to prevent #HE was <10 across all quartiles of pre-scan hematoma growth rate, & largest benefit was observed in pts within the highest quartile (>/=11.4 mL/hr), where NNT to prevent hematoma expansion was 4 : pic.twitter.com/3bsQNU84lz
— cardio-met (@cardiomet_CE) February 8, 2024
17b) In this secondary analysis #ISC24, the 30d #thrombotic event rate was stratified by the same parameters you saw above: pic.twitter.com/dUCZ873hLv
— cardio-met (@cardiomet_CE) February 8, 2024
17d) Thus these metrics can be used to identify patients that would have the greatest benefit when balancing reduction in #hematoma expansion compared with potential excess #thrombotic events with #andexanet treatment.
— cardio-met (@cardiomet_CE) February 8, 2024
18b) Case 1 is a left putaminal hemorrhage with pre-scan hematoma growth rate of 12 mL/hr. Her predicted risk of #HE with usual tx = 59%. NNT with #andexanet to 🚫HE = 4, vs NNH to cause a #thrombotic event of 26 ➡️ favorable risk-benefit balance. pic.twitter.com/0JcqSWso7z
— cardio-met (@cardiomet_CE) February 8, 2024
19a) In summary, this secondary analysis of #ANNEXa_I showed that higher hematoma growth rate—a composite of time from symptom onset and baseline hematoma volume—predicts hematoma expansion but not thrombotic events.
— cardio-met (@cardiomet_CE) February 8, 2024
20) The full presentation of #ANNEXa_I is forthcoming, as are other subanalyses. Meanwhile, let's review what you learned at #ISC2024:
— cardio-met (@cardiomet_CE) February 8, 2024
21b) It's a, use of #andexanet vs usual care. ⬆️ pre-scan hematoma growth rate ⬆️ the risk of #HE and there was no independent association with anti-FXa activity after adjustment for andexanet treatment, #ICH volume, or time from symptom onset to treatment.
— cardio-met (@cardiomet_CE) February 8, 2024
22b) It’s d—NONE of those! In all circumstances the NNT to prevent #HE was <10 (due to the largest absolute ⬇️with #andexanet tx), but this benefit was amplified substantially . . .
— cardio-met (@cardiomet_CE) February 8, 2024
23) Great job!
— cardio-met (@cardiomet_CE) February 8, 2024
Claim your 🆓 0.5hr CE/#CME NOW at https://t.co/lgW9NON4ff.
This is @Ash_Shoamanesh from #ISC2024, encouraging YOU 🫵 to FOLLOW @cardiomet_ce for timely, engaging, expert-led #MedEd!