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Abstract: TH-OR099

Rivaroxaban vs. Warfarin for Prevention of Ischemic Stroke/Systemic Embolism (ISSE) in Patients with Non-Valvular Atrial Fibrillation (NVAF) and Stage 4-5 CKD

Session Information

Category: Hypertension and CVD

  • 1401 Hypertension and CVD: Epidemiology, Risk Factors, and Prevention

Authors

  • Weir, Matthew R., University of Maryland School of Medicine, Baltimore, Maryland, United States
  • Ashton, Veronica, Janssen Scientific Affairs, Titusville, New Jersey, United States
  • Ammann, Eric M., Mu Sigma, Bangalore, India
  • Moore, Kenneth Todd, Janssen Medical Affairs, Titusville, New Jersey, United States
  • Shrivastava, Shubham, Mu Sigma, Bangalore, India
  • Peterson, Eric D., Duke University School of Medicine, Durham, North Carolina, United States
Background

There is limited evidence on the effectiveness and safety of direct-acting oral anticoagulants (DOACs) among patients with NVAF and advanced CKD. This study compared the risks of ISSE and major bleeding in patients with NVAF and stage IV-V CKD treated with rivaroxaban or warfarin.

Methods

Using data from the Optum Deidentified Electronic Health Record (EHR) Database, we selected patients with NVAF and stage IV-V CKD who initiated therapy with rivaroxaban or warfarin from November 1, 2011 through June 30, 2018. Selected patients were required to both be diagnosed with CKD and have an estimated creatinine clearance <30 mL/min and/or evidence of dialysis. Propensity score (PS) matching was used to balance rivaroxaban and warfarin patients on 97 measured baseline covariates. Hospitalizations for ISSE and major bleeding over 2 years following treatment initiation were ascertained with validated endpoint definitions. Outcomes were analyzed as time-to-event data using Kaplan-Meier survival estimators and Cox regression.

Results

781 rivaroxaban patients were PS-matched to 1,536 warfarin patients; after matching, all baseline covariates were well balanced (absolute standardized difference<0.1). The mean patient age was 80 years; 62% were female; 82% and 18% had CKD stage IV and V, respectively. The relative hazard (HR) of ISSE associated with rivaroxaban use compared to warfarin use was 0.93 (95% CI: 0.46, 1.90; p=0.85), and the corresponding HR for major bleeding was 0.91 (95% CI: 0.65, 1.28; p=0.91).

Conclusion

No statistically significant difference in the risk of ISSE or major bleeding was found between patients treated with rivaroxaban or warfarin. While further study is needed, rivaroxaban appears to be a reasonable alternative to warfarin for ISSE prevention in the setting of NVAF and stage IV-V CKD.

Funding

  • Commercial Support