2) Our 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 #MedEd pic.twitter.com/tDuWRu0Stb
— cardio-met (@cardiomet_CE) October 10, 2023
4) We are bringing you #ANNEXa_I top-line results. You'll want to contextualize these, so be sure to check out yesterday's posts, unrolled at https://t.co/6sb8aUmcC8, and get the lay of the land while you earn yet another 0.5hr 🆓CE/#CME! pic.twitter.com/Y6I3ftJXh7
— cardio-met (@cardiomet_CE) October 10, 2023
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." pic.twitter.com/Fr10G3NmnK
— cardio-met (@cardiomet_CE) October 10, 2023
6b) Following a planned interim assessment of efficacy (n=450), an independent #DSMB concluded that #andexanet demonstrated superior hemostatic efficacy after 1 month follow-up compared with usual care, and stopped the trial early.
— cardio-met (@cardiomet_CE) October 10, 2023
Hence the #LBCT at #WSC2023. pic.twitter.com/Hb2kLDn3eL
8) 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) October 10, 2023
9b) Among those pts randomized to usual care, 87% received #PCC.
— cardio-met (@cardiomet_CE) October 10, 2023
⏱️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/0UdNfIaTOW
11) 🛑🩸Primary outcome: excellent or good #hemostatic efficacy occurred more often w/andexanet (64%) vs usual care (54%).
— cardio-met (@cardiomet_CE) October 10, 2023
👉This ➡️11 more excellent/good #hemostatic efficacy outcomes /100 pts tx'd w/#andexanet.
👉Benefit driven mostly by ⬆️ rates of excellent hemostasis.
13) There was no diff in achieving good functional outcome (#mRS ≤3 at 30d) or 30d mortality between pts tx'd with #andexanet (28% & 28%, respectively) or those tx'd with usual care (31% & 26%).
— cardio-met (@cardiomet_CE) October 10, 2023
👉The trial wasn’t sufficiently powered for these predefined secondary outcomes.
15) There were no significant treatment interactions amongst pre-specified subgroups, including patients destined to receive #PCC if assigned to usual care, time from symptom onset to baseline scan, and baseline #hematoma volume. pic.twitter.com/gMkt3kNgBH
— cardio-met (@cardiomet_CE) October 10, 2023
17a) This trial demonstrated that #andexanet rapidly ⬇️ anti-#FXa activity & ⬆️ rate of #hemostatic
— cardio-met (@cardiomet_CE) October 10, 2023
efficacy, but at a cost of ⬆️rate of #thrombotic
events compared to usual care.
18) Thus #andexanet_alfa can be considered for patients with acute intracerebral hemorrhage #ICH, associated with #FXa inhibitor therapy, and in particular in patients with lower #thrombotic risk.
— cardio-met (@cardiomet_CE) October 10, 2023
20) The evidence basis for #reversal/#repletion strategies in anti-#FXa–#DOAC-associated #ICH now includes randomized data. Most importantly, the comparison between #andexanet and usual care turned out to be andexanet vs (87%) #PCC.
— cardio-met (@cardiomet_CE) October 10, 2023
21b) From these data, overall benefit–reversal (#andexanet) vs usual care (87% #PCC)–can be assessed by ⚖️ what?
— cardio-met (@cardiomet_CE) October 10, 2023
a. Functional clinical outcomes & hematoma expansion
b. Functional clinical outcomes & thrombotic events
c. Hematoma expansion & thrombotic events
d. None of above
22a) Now–in #ANNEXa-I, by approximately how much did the standard dose of #andexanet alfa ⬇️ anti-FXa activity in this population of DOAC-associated #ICH?
— cardio-met (@cardiomet_CE) October 10, 2023
23) So go reward yourself!! 🏆🥇
— cardio-met (@cardiomet_CE) October 10, 2023
Claim your 🆓CE/#CME NOW at https://t.co/bQ4qvD5Dzb.
This is @Ash_Shoamanesh signing off for now from #WSC2023 and encouraging YOU 🫵 to FOLLOW @cardiomet_ce for more timely, engaging, expert-led #MedEd!