#1994 Analysis of dynamics of parameters of safety and effectiveness of rivaroxaban in patients with stage IV chronic kidney disease and atrial fibrillation

Abstract

Abstract Background and Aims Research in the field of comorbidity of chronic kidney disease (CKD) and atrial fibrillation (AF) is becoming increasingly relevant, especially given the continuously increasing prevalence of this arrhythmia and its contribution to the risk of adverse events, the unity of factors in the development and progression of these diseases. This comorbidity is accompanied by an increased risk of thromboembolic complications (TEC) and atherothrombotic events, as well as the incidence of bleeding during anticoagulant therapy (ACT), which undoubtedly underlies the higher rates of cardiovascular and overall mortality in this cohort of patients. In this regard, we set the following goal: analysis of the dynamics and assessment of the safety parameters and effectiveness of the use of rivaroxaban in patients with a glomerular filtration rate (GFR) of 15–29 ml/min/1.73 m2 with non-valvular atrial fibrillation. Method The medical records of 12,026 patients were analyzed; non-valvular AF was diagnosed in 3,715 cases. 502 (15%) patients had stage IV CKD or a sustained decrease in GFR to 15–29 l/min/1.73 m2 during hospitalization. Of these, 109 (3%) patients met the inclusion criteria and were randomized 2:1 to rivaroxaban 15 mg (n = 73) or warfarin (n = 36). The average follow-up period was 18 months. Of the 109 included patients, 2 refused to participate in the study, contact with 9 was lost, 8 patients started taking another direct oral anticoagulant, CKD progressed to stage V in 4 patients, and antiplatelet agents were added in 6 cases. Results To assess the dynamics of changes in creatinine levels and GFR, mixed linear models were constructed, where the individual dynamics of each patient's indicators were selected as random effects, and time and drug intake were selected as fixed effects. A graphical interpretation of the dynamics and differences is presented in Figs 1 and 2. There was a significant improvement in the dynamics of creatinine and GFR in the rivaroxaban group compared to the warfarin group: while patients receiving rivaroxaban had an increase in GFR and a decrease in creatinine levels, patients taking warfarin, on the contrary, showed inverse dynamics in renal function indicators. It should be noted that during the study, a transition from stage IV CKD to stage III was recorded in 43% of patients in the rivaroxaban group and in 34% in the warfarin group (p = 0.26). There were no significant differences in the incidence of any acute cerebrovascular accident, myocardial infarction and all-cause mortality (warfarin—1.4%; 6.9%; 6.8% versus rivaroxaban—5.6%; 2.85; 8.3% (p = 0.25; 0.66; 0.78). Patients taking warfarin were significantly more likely to develop minor bleeding compared to rivaroxaban (36.9% versus 61.1% (p = 0. 01)) and all clinically significant bleeding (10.9% vs. 27.7% (p = 0.03)) according to the ISTH scale. In the warfarin group, TTR>70% was achieved in 94% of patients. All-cause readmission rates were 43% in the rivaroxaban group and 48% in the warfarin group (p = 0.57). Among these patients, 36.9% and 40.7% (respectively) were hospitalized for emergency reasons (p = 0.96). Conclusion In patients with atrial fibrillation and a low glomerular filtration rate (eGFR <30 ml/min/1.73 m2), it is reasonable to consider the use of rivaroxaban based on the current study showing a slower rate of decline in renal function, as well as favorable efficacy and safety profiles of rivaroxaban compared with warfarin in this group of patients.