Key result
Real-world management of rivaroxaban-related major bleeding is highly heterogeneous, with a 90-day all-cause mortality of 17% and a 10% incidence of thrombotic events.
Why the study?
A specific reversal agent for rivaroxaban is unavailable in Australasia, and international consensus guidelines vary on bleeding management.
Cohort (n=112)
Yes
Real-world management of rivaroxaban-related major bleeding is highly heterogeneous, highlighting the need for evidence-based guidance to standardize care and potentially improve clinical outcomes.
Heterogeneous real-world management of rivaroxaban bleeding signals high risk; leaves open whether standardized protocols improve outcomes in prospective trials.
BACKGROUND: Rivaroxaban is used increasingly as an oral anticoagulant; however, a specific reversal agent is not currently available in the Australasian setting. There is also variation across international consensus guidelines regarding advice on the management of bleeding. AIMS: To review the real-world management of rivaroxaban-associated major bleeding across the public hospitals of New Zealand's largest city. METHODS: A retrospective cohort analysis was performed of patients prescribed rivaroxaban who presented to four metropolitan hospital Emergency Departments between 1 August 2018 and 31 May 2021 with major bleeding as defined by the International Society on Thrombosis and Haemostasis. RESULTS: One hundred and twelve patients were identified, accounting for 115 major bleeding presentations. Upper gastrointestinal (34%) and intracranial (31%) bleeding sites were most common. Procedural intervention was required in 44% of patients. Haemostatic management involved tranexamic acid (TXA) in 26%, prothrombin complex concentrate (PCC) in 55% (dose range 1000-6000 IU or 10-65 IU/kg), vitamin K in 16% and fresh frozen plasma in 1%. Rivaroxaban was discontinued permanently following 56 (49%) events, switched to another anticoagulant in 24 (21%) and withheld in 30 (26%) from 2 days to 3 months (median 8.5 days). All-cause mortality at 90 days after bleeding was 17% (19 patients), and the incidence of combined venous and arterial thrombotic events was 10%. CONCLUSIONS: There is considerable heterogeneity in the acute clinical management of patients presenting with rivaroxaban-related major bleeding. The use of PCC and dosage administered is inconsistent. TXA was utilised in only approximately one-quarter of all cases. Evidence-based guidance for treating rivaroxaban-related bleeding would improve the management of these patients and potentially improve clinical outcomes.
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Grainger et al. (2022) conducted a cohort in Rivaroxaban-associated major bleeding (n=112). Rivaroxaban-associated major bleeding was evaluated on All-cause mortality at 90 days. Real-world management of rivaroxaban-related major bleeding is highly heterogeneous, with a 90-day all-cause mortality of 17% and a 10% incidence of thrombotic events.
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