Physicians' Academy for Cardiovascular Education

Effective hemostasis and lower mortality with DOAC reversal agent, but inappropriate usage occurs

Performance of idarucizumab as antidote of dabigatran in daily clinical practice

Literature - Van der Wall SJ, Van Rein N, Van den Bemt B et al. - Europace 2018; 0, 1–7

Introduction and methods

International guidelines recommend usage of idarucizumab, a monoclonal antibody fragment that binds to the direct oral anticoagulant (DOAC) dabigatran, for urgent dabigatran reversal in the presence of life-threatening bleeding or urgent surgery associated with high risk of bleeding [1,2]. However, practice-based data on the usage of idarucizumab for urgent dabigatran reversal are scarce. Therefore, this study aimed to determine the appropriateness of idarucizumab usage as well as its hemostatic effectiveness and clinical outcomes in daily practice.

This Dutch observational, multicenter cohort study included consecutive patients who were treated with idarucizumab between 2016 and 2018 (n=88) and followed them for 90 days. Data on idarucizumab usage and outcomes were collected by investigating medical records, including medical notes, laboratory results, radiology reports, and other relevant details.

The primary outcome was the appropriateness of idarucizumab usage, based on criteria proposed in an expert consensus of the ISTH on reversal of DOACs. Uncontrollable bleeding was defined as meeting one or more of the following criteria: symptomatic intracranial bleeding, a reduction in hemoglobin (Hb) of ≥5g/dL, transfusion of ≥4 units of blood or packed cells, bleeding requiring use of intravenous inotropic agents, or necessitating surgical intervention (one that could not be delayed for ≥8 hours). An additional criterion for appropriateness in this study was indicators for the presence of dabigatran plasma levels. Secondary outcomes were hemostatic effectiveness after administration for urgent reversal in bleeding events and incidence of thromboembolism, (re-)bleeding and death after 90 days. 53 (60%) Patients who received idarucizumab presented with bleeding, and 35 (40%) required urgent intervention.

Main results

Appropriateness of idarucizumab usage

Hemostatic effectiveness

Clinical outcomes

Conclusion

In this observational study idarucizumab usage was considered inappropriate in 28% of patients, mostly because interventions could have been delayed and gastrointestinal bleeding complications might have responded to supportive measures alone. However, it should be noted that the criteria applied to judge appropriateness have not been tested in clinical trials and may not fully reflect daily clinical care. When effective hemostasis was achieved (in two-thirds) in bleeding patients, this was associated with a lower mortality risk as compared with ineffective hemostasis.

References

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