July 3, 2020Future Cardiology
Real-world Management of Oral Factor Xa inhibitor-related Bleeds With Reversal Or Replacement Agents Including Andexanet Alfa and four-factor Prothrombin Complex Concentrate: A Multicenter Study
Why the study?
The real-world utilization and outcomes associated with managing oral factor Xa inhibitor-related major bleeds needed to be described.
Does the choice of reversal or replacement agent (such as andexanet alfa) improve in-hospital mortality in patients with oral factor Xa inhibitor-related major bleeds compared to other agents or no agents?
Population
3030 oral factor Xa inhibitor-related major bleed hospitalizations across 45 US hospitals
Comparison
Andexanet alfa vs four-factor prothrombin complex concentrate vs fresh frozen plasma vs other agents vs no agents
Design
Multicenter retrospective electronic health record study
Authors
Discussion
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Member takes
Implication
Real-world FXai bleed management patterns are hypothesis-generating; leaves open optimal reversal strategies in observational data.
Structured PICO
Does the choice of reversal or replacement agent (such as andexanet alfa) improve in-hospital mortality in patients with oral factor Xa inhibitor-related major bleeds compared to other agents or no agents?
P
Population
3,030 patients hospitalized for oral factor Xa inhibitor (FXai)-related major bleeds across 45 US hospitals, average age 68 years, 47% women.
I
Intervention
Reversal or replacement agents including andexanet alfa, four-factor prothrombin complex concentrate (4F-PCC), fresh frozen plasma (FFP), or other agents.
C
Comparator
Comparison between different reversal/replacement agents (andexanet alfa, 4F-PCC, FFP, other agents) and no agents.
O
Outcome
In-hospital mortalityhard clinical
In a real-world cohort of patients with FXa inhibitor-related major bleeds, use of andexanet alfa was associated with lower in-hospital mortality compared to 4F-PCC, FFP, or no reversal agent.
Cite This Study
Coleman et al. (2020) studied this question.