Comparative Effectiveness of Rivaroxaban VS Vitamin K Antagonist In Routine Care Patients Treated For Non-Valvular Atrial Fibrillation In Germany – A Renal Impairment Subgroup Analysis

• Published in: Value in health Vol. 20; no. 9; p. A604
• Main Authors: Bonnemeier, H, Huelsebeck, M, Kloss, S
• Format: Journal Article
• Language: English
• Published: Lawrenceville Elsevier Science Ltd 01.10.2017
• Subjects: Antagonists; Anticoagulants; Atrial fibrillation; Cardiac arrhythmia; Clinical medicine; Cohort analysis; Drug therapy; Fibrillation; Hemorrhage; Hostility; Illnesses; Ischemia; Kidney diseases; Patients; Renal function; Risk reduction; Thromboembolism; Vitamin K; Vitamins; Germany
• ISSN: 1098-3015; 1524-4733
• DOI: 10.1016/j.jval.2017.08.1167

OBJECTIVES: There is a strong relationship between renal function and thromboembolic events for both vitamin-K antagonists and rivaroxaban in patients treated for non-valvular atrial fibrillation (NVAF). Until now, only a few studies showed evidence of effectiveness and safety of anticoagulants in routine clinical practice in Germany where Phenprocoumon is the predominantly prescribed VKA. METHODS: Data from German sickness funds between January 1st, 2012 and March 31st, 2016 were extracted and a new user cohort study comparing patients treated with either rivaroxaban or vitamin K antagonist (phenprocoumon) was conducted. A multivariate Cox-regression was performed to calculate adjusted hazard ratios (HR) for the risk of ischemic stroke as well as intracranial hemorrhage in the overall population as well as in patients with renal impairment. RESULTS: 33,668 newly treated patients were identified and enrolled in the study: 13,155 patients on rivaroxaban (mean CHA2DS2-VASC score: 3.49; median observation time: 275 days) and 20,513 patients on phenprocoumon (mean CHA2DS2-VASC score: 3.78; median observation time: 160 days). Of these, 1,954 patients on rivaroxaban and 3,871 patients on phenprocoumon were coded as renally impaired. A significant risk reduction for ischemic stroke rivaroxaban vs. phenprocoumon was found in the overall population; HR: 0.77 (0.63; 0.93); p<0.05. For renally impaired patients the HR was 0.85 (0.56; 1.28); p=0.428; for intracranial hemorrhage 0.86 (0.54; 1.23); p=0.403 and 0.531 (0.21; 1.33); p=0.176 respectively. CONCLUSIONS: The analysis of the overall population showed a significant reduction in stroke risk for rivaroxaban. Although the number of patients with renal impairment in this study is still low, point estimates indicate a strong protective trend regarding effectiveness and safety of rivaroxaban vs. phenprocoumon. Additionally, the follow-up time on treatment with rivaroxaban was remarkably higher than for phenprocoumon. This study is the first focusing on a renally impaired subgroup of patients with NVAF in Germany.