2) Our first-time expert author is #ANNEXa_I investigator David Seiffge MD @DavidSeiffge, Vascular neurologist at Inselspital Bern ??#FOAMed #FOAMcc #neurotwitter #cardiotwitter #ICH @ESOStroke @WorldStrokeOrg pic.twitter.com/RDJPwWn6fb
— cardio-met (@cardiomet_CE) May 15, 2024
4a) 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#ESOC2024
— cardio-met (@cardiomet_CE) May 15, 2024
5a) OK, let’s level-set:#ANNEXa_I was a randomized, open-label, multicenter trial (NCT03661528) enrolling adults 18+ within 15h of taking an anti-#FXa #DOAC presenting with #ICH within 6h of symptom onset and #GCS>7. pic.twitter.com/Ahh417dS1k
— cardio-met (@cardiomet_CE) May 15, 2024
5c) Data from #ANNEXa_I are so important because despite that indication, pts with #DOAC-related #ICH are often treated with only support, or with nonspecific coagulation factor #repletion with an agent such as 4F-#PCC.
— cardio-met (@cardiomet_CE) May 15, 2024
6a) Primary endpoint of #ANNEXa_I was rate of effective #hemostasis, defined as all of:
— cardio-met (@cardiomet_CE) May 15, 2024
?change from baseline in #NIHSS of no more than +6 at 12h
?≤35% ⬆️in #hematoma volume from baseline on repeat #CT/#MRI
?no rescue therapy given after 3h post-randomization pic.twitter.com/GqwmL4HxQB
7) 530 participants were enrolled (263 assigned to #andexanet, 267 to usual care). Baseline characteristics appeared equally distributed between the two study arms. Mean age was ~79 years old; ~45% were ♀️ . Indication for OAC was #AF in 87%; median #CHA2DS2VASc score =4.
— cardio-met (@cardiomet_CE) May 15, 2024
8b) Among those pts randomized to usual care, 87% received #PCC.
— cardio-met (@cardiomet_CE) May 15, 2024
⏱️Mean symptoms ➡️ baseline scan = 2.3 hrs
⏱️Mean scan ➡️randomization = 1.2 hrs
⏱️Median door to ?time in pts receiving #reversal or #repletion was 2.2 hrs pic.twitter.com/0VND1iOhO2
10) When using a higher threshold of #hematoma #expansion of 12.5 cc or more–which has a high #PPV for poor functional outcome in patients with #ICH at 90 days–there was a benefit 7 per 100 patients treated with #andexanet. pic.twitter.com/udqGV2XYtx
— cardio-met (@cardiomet_CE) May 15, 2024
12) The objective of this pre-specified analysis was to identify patients participating in the #ANNEXa-I trial who were at greatest risk for hematoma expansion #HE & therefore were most likely to benefit from #andexanet
— cardio-met (@cardiomet_CE) May 15, 2024
13b) 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/eLOdznBjXQ
— cardio-met (@cardiomet_CE) May 15, 2024
14b) In the #ISC24 analysis, it was shown that this #AE was not associated with those parameters that predicted #HE: pic.twitter.com/ovA2h6HEiY
— cardio-met (@cardiomet_CE) May 15, 2024
16) That brings us to this ? analysis, just presented at #ESOC2024 by @DavidSeiffge, which evaluates the clinical consequences of #HE & thromboembolic events in pts with #FXa-inhibitor–associated #ICH in #ANNEXa_I. pic.twitter.com/VgriHo2m9u
— cardio-met (@cardiomet_CE) May 15, 2024
18a) The #methodology was robust: To assess the association with 30-day mortality, the authors used a #Cox_regression analysis including #HE along with other potential confounders. #TE were included as time-depending co-variable in this model. pic.twitter.com/PEitWpYYaN
— cardio-met (@cardiomet_CE) May 15, 2024
19) So what did they find? #Thrombotic events overall (particularly #arterial thrombosis) and #hematoma expansion both are strongly associated with 30d #mortality. Other potential predictors? Not so much. pic.twitter.com/LQeHmHND8F
— cardio-met (@cardiomet_CE) May 15, 2024
20b) Note that due to the low event rate (only 13 #TE in the first 5 days), the Kaplan Meier curve is difficult to interpret. pic.twitter.com/K0i0KX5YFQ
— cardio-met (@cardiomet_CE) May 15, 2024
20d) More important for many pts/next of kin is what happens to those pts who survive – what is their #functional outcome? That is why the authors also assessed the association w/poor outcome (mRS 4-6), i.e. this endpoint includes pts who are bedridden or in ?.
— cardio-met (@cardiomet_CE) May 15, 2024
20f) Hey–who needs a reminder about #mRS?
— cardio-met (@cardiomet_CE) May 15, 2024
4⃣ moderately severe disability; unable to walk or attend to bodily functions without assistance
5⃣ severe disability; bedridden, incontinent, requires continuous care
6⃣ expired, during the hospital stay or after d/c
21b) #Thrombotic events are also associated with #mortality, but their impact on poor functional outcome remains uncertain. It is important to realize that #HE is 4-times more frequent than #TE!
— cardio-met (@cardiomet_CE) May 15, 2024
23a) And so we continue to learn more about #FXa-inhibitor #DOAC reversal strategies in #ICH.
— cardio-met (@cardiomet_CE) May 15, 2024
Which of the following factors are associated with 30-day mortality after an ICH in #ANNEXa_I?
a. post-reversal thrombotic events
b. post-reversal hematoma expansion
c. ♀️ sex
d. a & b
24c) It's b, and here's a reminder: pic.twitter.com/q9lsfUetFi
— cardio-met (@cardiomet_CE) May 15, 2024
26) Great job! It’s like you were right here in Basel!
— cardio-met (@cardiomet_CE) May 15, 2024
Claim your ? 0.75hr CE/#CME NOW at https://t.co/ThNRBQIRWS.
Many thanks to @DavidSeiffge from #ESOC2024, who encourages YOU ? to FOLLOW @cardiomet_ce for timely, engaging, expert-led #MedEd!