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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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Hauptverfasser: Tsivgoulis, Georgios (VerfasserIn) , Katsanos, Aristeidis H. (VerfasserIn) , Romoli, Michele (VerfasserIn) , Sarraj, Amrou (VerfasserIn) , Krogias, Christos (VerfasserIn) , Karapanayiotides, Theodoros (VerfasserIn) , Theodorou, Aikaterini (VerfasserIn) , Stefanou, Maria Ioanna (VerfasserIn) , Molina, Carlos A. (VerfasserIn) , Themistocleous, Marios (VerfasserIn) , Steiner, Thorsten (VerfasserIn) , Shoamanesh, Ashkan (VerfasserIn) , Palaiodimou, Lina (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: August 14, 2025
In: Journal of neurology, neurosurgery, and psychiatry
Year: 2025, Jahrgang: 96, Heft: 9, Pages: 852-860
ISSN:1468-330X
DOI:10.1136/jnnp-2024-335558
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1136/jnnp-2024-335558
Verlag, lizenzpflichtig, Volltext: https://jnnp.bmj.com/content/96/9/852
Volltext
Verfasserangaben: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
Beschreibung
Zusammenfassung: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.
Beschreibung:Zuerst veröffentlicht: 15. März 2025
Gesehen am 19.08.2025
Beschreibung:Online Resource
ISSN:1468-330X
DOI:10.1136/jnnp-2024-335558

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