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Abstract: TH-PO896

Comparative Safety and Effectiveness of Apixaban Dosing in Patients With Atrial Fibrillation and Severe CKD

Session Information

Category: CKD (Non-Dialysis)

  • 2201 CKD (Non-Dialysis): Epidemiology‚ Risk Factors‚ and Prevention

Authors

  • Xu, Yunwen, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, United States
  • Chang, Alex R., Geisinger Health, Danville, Pennsylvania, United States
  • Inker, Lesley Ann, Tufts Medical Center, Boston, Massachusetts, United States
  • McAdams-DeMarco, Mara, New York University Grossman School of Medicine and Langone Health, New York, New York, United States
  • Grams, Morgan, New York University Grossman School of Medicine and Langone Health, New York, New York, United States
  • Shin, Jung-Im, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, United States
Background

The United States Food and Drug Administration (FDA) recommends reduced dose of apixaban in atrial fibrillation (AF) patients with ≥2 of the following characteristics: age ≥80 years, weight ≤60 kg, or serum creatinine ≥1.5 mg/dL. Thus, the FDA-recommended dose for some patients with severe chronic kidney disease (CKD G4+: eGFR <30 ml/min/1.73 m2) is the standard dose (5 mg twice daily) and for others is the reduced dose (2.5 mg twice daily). On the other hand, the European Medicines Agency (EMA) recommends the reduced dose of apixaban for all patients with severe CKD (creatinine clearance 15-30 ml/min).

Methods

Using de-identified electronic health record data from the Optum Labs Data Warehouse, we identified patients with AF and non-dialysis dependent CKD G4+ initiating apixaban in 2013-2021. We compared the risks of bleeding (harm) and ischemic stroke (benefit) by apixaban dose (5 mg vs. 2.5 mg), adjusting for baseline characteristics by inverse probability of treatment weighting (IPTW). We used Fine-Grey subdistribution hazard models to account for the competing risk of death. We also examined the risk of death by apixaban dose using Cox regression.

Results

Among 4313 apixaban new users, 1705 (40%) received 5 mg and 2608 (60%) received 2.5 mg. Patients given 5 mg were younger (mean age 72 vs. 80 years), with greater weight (95 vs. 80 kg) and higher serum creatinine level (2.69 vs. 2.47 mg/dL). Mean eGFR was similar between the groups (24 vs. 24 ml/min/1.73 m2). In IPTW analyses, apixaban 5 mg (vs. 2.5 mg) was associated with a higher risk of bleeding (incidence rate difference [95% CI], 1.24 [0.19-2.29] per 100 person-years; subdistribution hazard ratio [95% CI], 1.47 [1.01-2.14]) (Figure). The risks for ischemic stroke and death did not differ by apixaban dose.

Conclusion

Use of 5 mg apixaban was associated with a higher risk of bleeding in patients with AF and CKD G4+, with a similar risk for ischemic stroke, supporting the current apixaban renal dosing recommendation by EMA.

Funding

  • NIDDK Support