ANNEXA-I
Trial question
What is the role of andexanet in patients with factor Xa inhibitor-associated intracerebral hemorrhage?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
46.0% female
54.0% male
N = 452
452 patients (207 female, 245 male).
Inclusion criteria: patients with acute intracerebral hemorrhage receiving factor Xa inhibitors.
Key exclusion criteria: GCS score < 7; surgery planned within 12 hours after enrollment; thrombotic event within 2 weeks before enrollment.
Interventions
N=224 andexanet (high-dose bolus or low-dose bolus over 15-30 minutes, followed by continuous infusion over 2 hours).
N=228 usual care (determined by local physicians at their discretion including prothrombin complex concentrate).
Primary outcome
Hemostatic efficacy
67%
53.1%
67.0 %
50.3 %
33.5 %
16.8 %
0.0 %
Andexanet
Usual
care
Significant
increase ▲
NNT = 7
Significant increase in hemostatic efficacy (67% vs. 53.1%; AD 13.4%, 95% CI 4.6 to 22.2).
Secondary outcomes
Significant increase in hematoma volume shrinkage ≤ 35% (76.7% vs. 64.6%; AD 12.1%, 95% CI 3.6 to 20.5).
No significant difference in NIHSS score change < 7 (87.9% vs. 83%; AD 4.6%, 95% CI -2 to 11.2).
No significant difference in hematoma volume expansion ≥ 12.5 mL (11.1% vs. 16.8%; ARD -5.6, 95% CI -12 to 0.8).
Safety outcomes
No significant difference in death.
Significant difference in thrombotic events (10.3% vs. 5.6%).
Conclusion
In patients with acute intracerebral hemorrhage receiving factor Xa inhibitors, andexanet was superior to usual care with respect to hemostatic efficacy.
Reference
Stuart J Connolly, Mukul Sharma, Alexander T Cohen et al. Andexanet for Factor Xa Inhibitor-Associated Acute Intracerebral Hemorrhage. N Engl J Med. 2024 May 16;390(19):1745-1755.
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