Zusammenfassung der Studie

Three thousand six hundred and four patients scheduled for a non-major lower limb surgery were randomized to receive oral rivaroxaban or subcutaneous enoxaparin for the prevention of major venous thromboembolic events. The primary outcome of interest was major venous thromboembolism, which was a composite of the incidence of symptomatic distal or proximal deep vein thrombosis, pulmonary embolism and venous thromboembolism. Secondary outcomes of interest included the incidence of major bleeding, non-major clinically relevant bleeding, thrombocytopenia, and mortality. Outcomes were assessed by telephone 30 days after the end of treatment, which lasted until the end of immobilization. Results of the study demonstrated that the incidence of major venous thromboembolism to be significantly lower in the rivaroxaban group compared to the enoxaparin group. No significant differences in all secondary outcomes were observed.