Author(s): BeyerWestendorf J, Frster K, Pannach S, Ebertz F, Gelbricht V,
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Abstract Worldwide, rivaroxaban is increasingly used for stroke prevention in atrial fibrillation and treatment of venous thromboembolism, but little is known about rivaroxaban-related bleeding complications in daily care. Using data from a prospective, noninterventional oral anticoagulation registry of daily care patients (Dresden NOAC registry), we analyzed rates, management, and outcome of rivaroxaban-related bleeding. Between October 1, 2011, and December 31, 2013, 1776 rivaroxaban patients were enrolled. So far, 762 patients (42.9\%) reported 1082 bleeding events during/within 3 days after last intake of rivaroxaban (58.9\% minor, 35.0\% of nonmajor clinically relevant, and 6.1\% major bleeding according to International Society on Thrombosis and Haemostasis definition). In case of major bleeding, surgical or interventional treatment was needed in 37.8\% and prothrombin complex concentrate in 9.1\%. In the time-to-first-event analysis, 100-patient-year rates of major bleeding were 3.1 (95\% confidence interval 2.2-4.3) for stroke prevention in atrial fibrillation and 4.1 (95\% confidence interval 2.5-6.4) for venous thromboembolism patients, respectively. In the as-treated analysis, case fatality rates of bleeding leading to hospitalizations were 5.1\% and 6.3\% at days 30 and 90 after bleeding, respectively. Our data indicate that, in real life, rates of rivaroxaban-related major bleeding may be lower and that the outcome may at least not be worse than that of major vitamin K antagonist bleeding, and probably better. This trial was registered at www.clinicaltrials.gov as identifier #NCT01588119. © 2014 by The American Society of Hematology.
This article was published in Blood
and referenced in Arrhythmia: Open Access