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REBEL EM – Emergency Medicine Blog
Health & Fitness:Medicine
ANNEXA-1: Andexanet Alfa Associated with Harm in DOAC Reversal
Background: In May of 2018, Andexanet alfa gained accelerated approval by the FDA for the reversal direct oral anticoagulants (DOACs) despite a lack of robust evidence for use. The 2022 AHA/ASA guidelines give the drug a level 2A recommendation and recommend it over the use of 4F-PCC (Greenberg 2022). FDA approval alongside guideline endorsement has led to the drug seeing a remarkable growth in use without a single high-quality study to support its use. The available data reports good hemostatic control: a subjective measure that is highly biased by unblinding and selection bias. More importantly, there are no studies comparing andexanet alfa to 4F-PCC or even placebo looking at important, patient-centered outcomes.
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Article: Connolly SJ et al. Andexanet for Factor Xa Inhibitor-Associated Acute Intracerebral Hemorrhage (ANNEXA-1). NEJM 2024; 390(19): 1745-55. PMID: 38749032
Clinical Question: Does the use of andexanet alfa in patients on DOACs with intracerebral hemorrhage improved hemostatic efficacy?
Population: Patients > 18 years of age on a factor Xa inhibitor (taken within 15 hours of randomization) with an acute intracerebral hemorrhage.
Outcomes:
Results:
Critical Results
Andexanet alfa
Usual Care
Difference (95% CI)
P Value
Primary Outcome
Hemostatic Efficacy
67% (150/224)
53.1% (121/228)
13.4 (4.6 – 22.2)
0.003
NIHSS change < 7 points
87.9% (188/214)
83.0% (181/218)
4.6 (-2.0 – 11.2)
Secondary Outcome
Anti-Factor Xa % Change
-94.5% (-96.6 – 88.9)
-26.9% (-54.2 – -9.5)
Safety Outcome
Thrombotic Events
10.3%
5.6%
4.6 (0.1 – 9.2)
0.048
TIA
0
0
Ischemic Stroke
6.5%
1.5%
Myocardial Infarction
4.2%
1.5%
DVT
0.4%
0.7%
PE
0.4%
2.2%
Arterial Embolism
1.1%
0.7%
Death
27.8%
25.5%
0.51
Strengths:
Limitations:
Discussion:
Author Conclusion: “Among patients with intracerebral hemorrhage who were receiving factor Xa inhibitors, andexanet resulted in better control of hematoma expansion than usual care but was associated with thrombotic events, including ischemic stroke.”
Clinical Take Home Point: The authors conclusions are correct. However, they don’t properly stress the findings.
Treatment of patients with intracerebral hemorrhage on a DOAC with Anexanet alfa did not improve clinical outcomes when compared to usual care. Based on safety data, andexanet alfa resulted in increased harm to patients. Andexanet alfa should not be part of the standard treatment in this scenario based on the available evidence.
References:
For More Thoughts on This Topic Checkout:
Post Peer Reviewed By: Salim R. Rezaie, MD (Twitter/X: @srrezaie)
The post ANNEXA-1: Andexanet Alfa Associated with Harm in DOAC Reversal appeared first on REBEL EM - Emergency Medicine Blog.
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