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Comparative Safety and Effectiveness of Warfarin or Rivaroxaban Versus Apixaban in Patients With Advanced CKD and Atrial Fibrillation: Nationwide US Cohort Study

Am J Kidney Dis. 2023 Oct 13:S0272-6386(23)00859-4. doi: 10.1053/j.ajkd.2023.08.017. Online ahead of print.


RATIONALE & OBJECTIVE: Head-to-head data comparing the effectiveness and safety of oral anticoagulants in patients with atrial fibrillation (AF) and advanced CKD are lacking. We compared the safety and effectiveness of warfarin or rivaroxaban vs. apixaban in patients with AF and non-dialysis CKD stages 4-5.

STUDY DESIGN: Propensity score matched cohort study.

SETTING: & Participants: Two nationwide U.S. claims databases, Medicare and Optum’s de-identified Clinformatics® Data Mart Database (01/01/2013-03/31/2022). New initiators of warfarin vs. apixaban (N = 12,488) and rivaroxaban vs. apixaban (N = 5720) with nonvalvular AF and CKD stage 4-5.

EXPOSURES: Warfarin, rivaroxaban or apixaban.

OUTCOMES: Primary outcomes included major bleeding and ischemic stroke. Secondary outcomes included all-cause mortality, major gastrointestinal bleeding, and intracranial bleeding.

ANALYTICAL APPROACH: Cox regression was used to estimate hazard ratios (HR) and 1:1 propensity score matching was used to adjust for 80 potential confounders.

RESULTS: Compared with apixaban, warfarin initiation was associated with a higher rate of major bleeding (HR 1.85; 95% CI 1.59-2.15), including major gastrointestinal bleeding (1.86; 1.53-2.25) and intracranial bleeding (2.15; 1.42-3.25). Rivaroxaban vs. apixaban was also associated with a higher rate of major bleeding (1.69; 1.33-2.15). All-cause mortality was similar for warfarin (1.08; 0.98-1.18) or rivaroxaban (0.94; 0.81-1.10) vs. apixaban. Furthermore, no statistically significant differences for ischemic stroke were observed for warfarin (1.14; 0.83-1.57) or rivaroxaban (0.71; 0.40-1.24) vs. apixaban, although confidence intervals were wide. Similar results were observed for warfarin vs. apixaban in the positive control cohort of patients with CKD stage 3, consistent with randomized trial findings.

LIMITATIONS: Few ischemic stroke events, potential residual confounding.

CONCLUSIONS: In patients with AF and advanced CKD, rivaroxaban and warfarin were associated with a higher rate of major bleeding compared with apixaban, suggesting a superior safety profile for apixaban in this high-risk population.

PMID:37839687 | DOI:10.1053/j.ajkd.2023.08.017

By Nevin Manimala

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