Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial.

Piccini JP, Garg J, Patel MR, et al.
Eur Heart J 2014;35:1873-1880.
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Review by : M. Levi
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Rivaroxaban is a novel oral anticoagulant directed against factor Xa. In clinical trials, rivaroxaban was at least as effective as warfarin and had a comparable safety profile. This means that the most important adverse effect of rivaroxaban is the occurrence of severe bleeding complications. In view of the absence of a specific antidote or proven strategy that can be used to reverse the anticoagulant effect of rivaroxaban, the management of these severe haemorrhagic complications is not completely clear. In this study, the authors analysed the management and outcome of major bleeding events in the ROCKET AF trial, in which rivaroxaban was compared with warfarin in patients with atrial fibrillation. They observed less use of plasma and prothrombin complex concentrate in rivaroxaban-treated patients compared to patients on warfarin. However, the use of red cell transfusion and clinical outcomes were similar in both groups.

It is a bit difficult to conclude what these observational data mean. It may be that patients on rivaroxaban had less requirement for plasma or prothrombin complex concentrate, for example due to the short half-life of the drug. However, it can also be true that many physicians did not believe that plasma or coagulation factor concentrates would be helpful in this situation at the time of the trial. Hence, the interpretation of these results is quite complex. The good news is that, even in the absence of a specific antidote, the outcome of bleeding associated with rivaroxaban is similar to that observed with warfarin.

– Marcel Levi

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