Prothrombin complex concentrates for DOAC‐associated bleeding, global coagulation assays, and assessments of clinical hemostasis: How to gauge the impact?

Bavalia and colleagues build on published data from 2 observational studies on the use of PCCs for the management of FXa inhibitor‐associated bleeding. 5,6 In a cohort study by Majeed and colleagues, 5 84 patients received PCC for management of rivaroxaban‐ or apixaban‐associated bleeding. [...]direct comparisons between studies are problematic due to differences in population demographics, recruitment procedures and inclusion criteria, PCC dosing, bleeding sites, and definitions of “effective” hemostasis. Evidence of a biochemical effect of PCC on DOAC anticoagulant effect is drawn primarily from in vitro and animal studies, as well as studies in human volunteers, which showed variable and modest corrections of conventional coagulation assays such as the PT. 7‐13 Several groups have also evaluated the impact of PCCs on global coagulation assays such as TGAs, which measure both kinetic (lag time, time to peak [TTP]) and quantitative (peak, endogenous thrombin potential [ETP]) parameters of thrombin generation. 14 Whereas conventional coagulation assays provide only the time to initiation of fibrin formation, TGAs provide in‐depth data on the speed and amount of thrombin generated by a patient’s plasma.