Why the study?
Data on clinical outcomes of DOAC-related emergencies were scarce, and it was unknown to what extent PCC restores thrombin generation in factor Xa inhibitor-related emergencies.
Does prothrombin complex concentrate or idarucizumab provide effective hemostasis in patients with DOAC-related emergencies?
Does prothrombin complex concentrate or idarucizumab provide effective hemostasis in patients with DOAC-related emergencies?
In DOAC-related emergencies, effective hemostasis can be achieved in the majority of patients using reversal agents like PCC or idarucizumab, with low thromboembolic complication rates but high overall mortality.
PCC use yielded 67% hemostasis in FXa-I emergencies; leaves open optimal reversal strategies pending randomized trials.
BACKGROUND: In the initial absence of specific reversal agents for factor Xa inhibitors (FXa-Is), prothrombin complex concentrate (PCC) as a hemostatic agent has been recommended by guidelines. Since 2017, idarucizumab has been registered for dabigatran reversal. Still, data on the clinical outcome of direct oral anticoagulant (DOAC)-related emergencies (major bleeding or urgent interventions) is scarce. In addition, it is unknown to what extent PCC restores thrombin generation in FXa-I-related emergencies. Our aim was to describe management and clinical outcomes of DOAC-related emergencies and to assess the laboratory effect of PCC in patients with FXa-I emergencies. METHODS: In this prospective cohort study in 5 Dutch hospitals, patients presenting with DOAC-related emergencies were eligible. The primary outcome was effective hemostasis according to the ISTH definition. Safety outcomes were 30-day mortality and thromboembolic rate. In patients treated with PCC, additional blood samples were taken to assess the effect on thrombin generation. RESULTS: We included 101 patients with major bleeding (FXa-I, 76; dabigatran, 25) and 21 patients requiring an urgent intervention (FXa-I, 16; dabigatran, 5). Of patients with major bleeding, 67% were treated with PCC or idarucizumab. Effective hemostasis, 30-day mortality, and thromboembolism rate were 67%, 22%, and 1%, respectively. In a subset of bleeding patients on FXa-I managed with PCC, thrombin generation increased, with 96% immediately after PCC administration. In patients requiring an urgent intervention, effective hemostasis, 30-day mortality, and thromboembolic rate were 95%, 14%, and 5%. CONCLUSIONS: Effective hemostasis was achieved in the majority of patients presenting with DOAC-related emergencies;, thromboembolic complications were rare, and mortality was quite high.
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Bavalia et al. (2020) studied this question.
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