OC 74.5 - Safety Outcomes of Oral Anticoagulant Therapy in Patients with Atrial Fibrillation and Chronic Kidney Disease.

Background: The comorbid conditions of atrial fibrillation (AF) and chronic kidney disease (CKD) leads to an increased risk of thromboembolic complications. But with the deterioration of kidney function, the risk of hemorrhagic complications increases dramatically. This problem makes it difficult to choose an effective and safe oral anticoagulant therapy.

Aims: The aim of study was evaluation of safety parameters for the using of rivaroxaban in patients with stage 4 CKD with AF.

Methods: The study included 109 patients with stage 4 CKD (eGFR – 15-29 ml/min/1,72 m2) and AF. They were randomized in a 2:1 ratio to receive either rivaroxaban 15 mg (n=73) or warfarin (n=36) for 18 months. In the warfarin group, time in therapeutic range (TTR) >70% was achieved in 34 (94%) patients.

Results: According to the BARC and ISTH scale, minor bleeding occurred in the rivaroxaban group 42,4% (n=31) and 36,9% (n=27), in the warfarin group 72,2% (n=26) and 61,1% (n=22), (p < 0,01 and p=0,01) respectively; minor clinically significant bleeding on rivaroxaban 2,74% (n=2) and 8,2% (n=6), on warfarin 8,33% (n=3) and 19,4% (n=7), (p=0,32 and p=0,06); major bleeding on rivaroxaban 2,74% (n=2) and 2,74% (n=2), on warfarin 8,33% (n=3) and 8,33% (n=3), (p=0,32) respectively. Patients treated with warfarin were significantly more likely to develop all clinically significant bleeding compared with rivaroxaban on the BARC (p=0,06) and ISTH (p=0,03) scales. Analysis of the hemoglobin level did not reveal significant dynamics and significant differences between the groups: the median hemoglobin level at inclusion was 129 g/l in the rivaroxaban group and 123 g/l in the warfarin group (p=0,3), after 18 months - 130 g/l and 121 g/l, respectively (p=0,7).

Conclusion(s): In this study, we obtained data indicating a favorable safety profile of rivaroxaban compared with warfarin in patients with AF and stage 4 CKD.