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  • Title: Real-world outcomes of rivaroxaban treatment in patients with nonvalvular atrial fibrillation and worsening renal function.
    Author: Nakagawara J, Ikeda T, Ogawa S, Kitazono T, Minematsu K, Miyamoto S, Murakawa Y, Takeichi M, Kidani Y, Okayama Y, Sunaya T, Sato S, Yamanaka S.
    Journal: J Cardiol; 2019 Dec; 74(6):501-506. PubMed ID: 31371191.
    Abstract:
    BACKGROUND: Rivaroxaban is a direct oral anticoagulant administered to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). The Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) was a prospective, observational, post-marketing surveillance study that examined the safety and effectiveness of rivaroxaban in routine clinical practice. This sub-analysis of the XAPASS investigated the outcomes of patients with worsening renal function (WRF). METHODS: The XAPASS included 11,308 patients with NVAF who began treatment with rivaroxaban. Of 9578 patients who completed 1-year follow-up, the 7509 patients, for whom the change in creatinine clearance could be assessed, were included in the present analysis. Patients with WRF were those with a decrease in creatinine clearance of ≥20% from enrollment to any time point; patients with stable renal function (SRF) were those without such a decrease. Outcomes in patients with WRF versus SRF were compared at 1 year. RESULTS: We identified 1229 patients with WRF and 6280 patients with SRF. Patients with WRF were older and had higher mean CHADS2 and modified HAS-BLED scores compared to patients with SRF. The incidence rates of any bleeding (hazard ratio: 1.12; 95% confidence interval: 0.88-1.41), major bleeding (1.20; 0.75-1.90), and the composite endpoint stroke/systemic embolism/myocardial infarction (1.06; 0.65-1.71) were similar between the two groups. CONCLUSIONS: No association between WRF and occurrence of any bleeding, major bleeding, and stroke/systemic embolism/myocardial infarction was observed in patients with AF on rivaroxaban treatment during 1-year follow-up in real-world clinical practice. Clinicaltrials.gov: NCT01582737.
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