Research and practice in thrombosis and haemostasis · 2026
Andexanet alfa for the reversal of anticoagulation: Dutch practice data.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Krommenhoek Jurjen F, Beekman Wendy, Kor Flip, Gal Pim, Berkhout Willemijn E M, Meijer Karina, Braeken Dionne C W, Klok Frederikus A, Cate Hugo Ten, Olie Renske H
Аннотация
BACKGROUND: Andexanet alfa is a reversal agent for factor Xa (FXa) inhibitors (rivaroxaban and apixaban) and is available for the treatment of severe FXa inhibitor-associated bleeding. However, an increase in thrombotic events after administration has been reported.
OBJECTIVES: This multicenter Dutch observational study aimed to provide insights into the characteristics, usage patterns, and clinical outcomes of the Dutch patient population treated with andexanet alfa.
METHODS: We included all patients treated with on- and off-label andexanet alfa from 6 of the 11 hospitals in the Netherlands that prescribed andexanet alfa between June 2019 and December 2023. Data were collected by LOGEX, a Dutch healthcare data company, using healthcare administrative data and questionnaires completed by clinicians at participating centers. Patient characteristics, details related to andexanet alfa administration, and 30-day clinical outcomes, including thrombotic events and all-cause mortality, were collected.
RESULTS: A total of 217 patients received andexanet alfa, including 192 treated on-label and 25 off-label. In the on-label group, the median age was 77 years (IQR, 69-82 years), and intracranial hemorrhage was the most common indication for reversal (61%). Most patients received a low dose (≤1000 mg) and were administered andexanet alfa within 4 hours of hospital admission (79%). The overall 30-day cumulative incidence of thrombotic events was 4.6%, and no thrombotic events occurred after anticoagulation was reinitiated. All-cause mortality was 34%, with similar rates between the on- and off-label groups.
CONCLUSION: Andexanet alfa was primarily prescribed for the reversal of FXa inhibitors in patients with intracerebral hemorrhage. We observed a lower incidence of thrombotic events than reported in clinical trials.
OBJECTIVES: This multicenter Dutch observational study aimed to provide insights into the characteristics, usage patterns, and clinical outcomes of the Dutch patient population treated with andexanet alfa.
METHODS: We included all patients treated with on- and off-label andexanet alfa from 6 of the 11 hospitals in the Netherlands that prescribed andexanet alfa between June 2019 and December 2023. Data were collected by LOGEX, a Dutch healthcare data company, using healthcare administrative data and questionnaires completed by clinicians at participating centers. Patient characteristics, details related to andexanet alfa administration, and 30-day clinical outcomes, including thrombotic events and all-cause mortality, were collected.
RESULTS: A total of 217 patients received andexanet alfa, including 192 treated on-label and 25 off-label. In the on-label group, the median age was 77 years (IQR, 69-82 years), and intracranial hemorrhage was the most common indication for reversal (61%). Most patients received a low dose (≤1000 mg) and were administered andexanet alfa within 4 hours of hospital admission (79%). The overall 30-day cumulative incidence of thrombotic events was 4.6%, and no thrombotic events occurred after anticoagulation was reinitiated. All-cause mortality was 34%, with similar rates between the on- and off-label groups.
CONCLUSION: Andexanet alfa was primarily prescribed for the reversal of FXa inhibitors in patients with intracerebral hemorrhage. We observed a lower incidence of thrombotic events than reported in clinical trials.