Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry.
Rivaroxaban is one of the new oral anticoagulants, specifically targeting factor Xa. It was shown to be as effective as vitamin K antagonists in clinical studies but is more convenient to use and, importantly, has a lower risk of bleeding complications. It is known that real-life incidence of haemorrhagic complications may differ from observations in clinical studies.
In this study, the authors observed 1776 patients on rivaroxaban in routine clinical practice. The incidence of major bleeding was 3.1 per 100 patient-years in patients who took the drug for prevention of thromboembolism in atrial fibrillation and 4.1 per 100 patient-years in patients with venous thromboembolism. These figures compare favourably with known rates of bleeding in patients on vitamin K antagonists. Remarkably, 9.1% of bleeding episodes required administration of prothrombin complex concentrates, the intervention that is most likely to reverse the anticoagulant effect of rivaroxaban.
The high incidence of minor bleeding events and the case fatality rate of 5-6% in patients hospitalised for bleeding underscore that, although the risk of bleeding is lower, the problem of anticoagulation-induced haemorrhage remains a very serious and relevant issue, also with the new anticoagulants.
– Marcel Levi
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