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: | , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
August 14, 2025
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| 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 
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| 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 |
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| 245 | 1 | 0 | |a Efficacy and safety of andexanet alfa for factor Xa inhibitor-associated intracranial haemorrhage |c 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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| 520 | |a 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. | ||
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| 700 | 1 | |a Romoli, Michele |e VerfasserIn |4 aut | |
| 700 | 1 | |a Sarraj, Amrou |e VerfasserIn |4 aut | |
| 700 | 1 | |a Krogias, Christos |e VerfasserIn |4 aut | |
| 700 | 1 | |a Karapanayiotides, Theodoros |e VerfasserIn |4 aut | |
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| 700 | 1 | |a Molina, Carlos A. |e VerfasserIn |4 aut | |
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| 700 | 1 | |a Shoamanesh, Ashkan |e VerfasserIn |4 aut | |
| 700 | 1 | |a Palaiodimou, Lina |e VerfasserIn |4 aut | |
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