Safety and Effectiveness of Rivaroxaban versus Standard Anticoagulation in deep Vein Thrombosis in routine clinical practice Subgroup analysis XALIA-DE for Germany

Standard acute and long-term treatment of patients with deep-vein thrombosis includes parenteral agents (e.g. low-molecular-weight heparin) followed by vitamin K antagonists. Recently, non-vitamin K antagonist oral anticoagulants are increasingly used for initial treatment and secondary prevention, because of their effectiveness shown in phase III randomized trials. Here we present a subgroup analysis of the German patients (XALIA-DE) included in the international XALIA study. The international, prospective, non-interventional study XALIA investigated the acute and long term therapy with rivaroxaban and standard anticoagulation therapy and confirmed the safety and efficacy of rivaroxaban documented in phase III clinical studies in routine clinical practice: Annual event rates for major bleeding, venous thromboembolism, and all-cause mortality were 1.2 %, 2.4 %, and 0.8 % per year, respectively, for rivaroxaban; these rates were 3.4 %, 3.9 %, und 6.2 % per year, respectively, in the standard anticoagulation group. The subgroup analysis XALIA-DE investigated whether results of the international study XALIA could be translated to German patients. 941 patients were included in the safety analysis (586 in the rivaroxaban group and 355 in the standard anticoagulation group). Patients in the rivaroxaban group were younger and fewer had active cancer. Incidence rates for major bleeding (1.6 vs. 4.1/100 patient years [py]), recurrent VTE (1.9 vs. 4.7/100 py) and all-cause mortality (1.6 vs. 6.8/100 py), respectively, were lower in the rivaroxaban group compared to the standard anticoagulation group. Incidence rates in XALIA-DE were comparable to those observed in XALIA and document a favorable benefit-risk profile of rivaroxaban in daily practice.