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Efficacy and safety of andexanet alfa for factor Xa inhibitor-associated intracranial haemorrhage

Background Current international guidelines suggest andexanet alfa (AA) for the management of factor Xa inhibitor-associated intracranial haemorrhage (ICH). However, those recommendations are based on low-quality evidence and there is uncertainty regarding the net clinical benefit of AA. - Methods W...

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Main Authors: Tsivgoulis, Georgios (Author) , Katsanos, Aristeidis H. (Author) , Romoli, Michele (Author) , Sarraj, Amrou (Author) , Krogias, Christos (Author) , Karapanayiotides, Theodoros (Author) , Theodorou, Aikaterini (Author) , Stefanou, Maria Ioanna (Author) , Molina, Carlos A. (Author) , Themistocleous, Marios (Author) , Steiner, Thorsten (Author) , Shoamanesh, Ashkan (Author) , Palaiodimou, Lina (Author)
Format: Article (Journal)
Language:English
Published: August 14, 2025
In: Journal of neurology, neurosurgery, and psychiatry
Year: 2025, Volume: 96, Issue: 9, Pages: 852-860
ISSN:1468-330X
DOI:10.1136/jnnp-2024-335558
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1136/jnnp-2024-335558
Verlag, lizenzpflichtig, Volltext: https://jnnp.bmj.com/content/96/9/852
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Author Notes:Georgios Tsivgoulis, Aristeidis H. Katsanos, Michele Romoli, Amrou Sarraj, Christos Krogias, Theodoros Karapanayiotides, Aikaterini Theodorou, Maria Ioanna Stefanou, Carlos A. Molina, Marios Themistocleous, Thorsten Steiner, Ashkan Shoamanesh, Lina Palaiodimou
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Summary:Background Current international guidelines suggest andexanet alfa (AA) for the management of factor Xa inhibitor-associated intracranial haemorrhage (ICH). However, those recommendations are based on low-quality evidence and there is uncertainty regarding the net clinical benefit of AA. - Methods We conducted a systematic review and meta-analysis including available randomised controlled clinical trials (RCTs) and observational studies that investigated efficacy and safety of AA compared with usual care for the treatment of factor Xa inhibitor-associated ICH. Good haemostatic efficacy, defined as haematoma expansion of ≤35% or ≤6 mL, was the primary outcome. Secondary efficacy outcomes were excellent haemostatic efficacy (≤20% haematoma expansion) and good functional outcome (modified Rankin Scale scores 0-3) at follow-up, while safety outcomes were mortality and thrombotic events at follow-up. - Results Eighteen studies (1 RCT) were included comprising a total of 1567 patients treated with AA versus 1969 patients receiving usual care. AA was associated with a higher likelihood of good haemostatic efficacy (RR=1.16; 95% CI=1.06 to 1.26) compared with usual care, while excellent haemostatic efficacy (RR=1.04; 95% CI=0.85 to 1.26) and good functional outcome (RR=0.92; 95% CI=0.53 to 1.62) were similar between the two groups. Regarding safety outcomes, similar rates of mortality (RR=0.77; 95% CI=0.56 to 1.04) and thrombotic events (RR=1.20; 95% CI=0.81 to 1.78) were documented. - Conclusions The present meta-analysis suggests AA is associated with improved haemostatic efficacy compared with usual care, with no significant differences observed in functional and safety outcomes. These findings indicate that AA may have a role in the management of factor Xa inhibitor-associated ICH, although further high-quality studies are needed to better define its net clinical benefit.
Item Description:Zuerst veröffentlicht: 15. März 2025
Gesehen am 19.08.2025
Physical Description:Online Resource
ISSN:1468-330X
DOI:10.1136/jnnp-2024-335558

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