J Am Pharm Assoc (2003). 2023 Dec 25:S1544-3191(23)00432-6. doi: 10.1016/j.japh.2023.12.020. Online ahead of print.
ABSTRACT
PURPOSE/BACKGROUND: Compare the efficacy and safety of apixaban and warfarin in patients with nonvalvular atrial fibrillation (NVAF) and end-stage renal disease (ESRD) on hemodialysis (HD). Apixaban decreased incidence of stroke and bleeding compared to warfarin in major clinical trials that excluded patients with severe renal dysfunction. Apixaban is no longer contraindicated in patients with ESRD on HD with NVAF based on pharmacokinetic studies. Limited clinical data exists for patients with ESRD on HD on apixaban.
METHODOLOGY: A retrospective chart review was performed on patients with a diagnosis of NVAF and ESRD on HD who were prescribed apixaban or warfarin for stroke prevention in the years 2018 through 2019. Patients charts were reviewed for up to a 2-year period. Patients on renal replacement therapy other than HD, those using anticoagulation for reasons other than NVAF, patients with Child-Pugh Class C cirrhosis, and those with severe mitral valve stenosis were excluded. The primary outcome was emergency department visit or hospital admission for ischemic stroke or TIA. Secondary outcomes included major or minor bleeding, and adverse effects.
RESULTS: There were 181 patients screened; 110 patients met eligibility criteria and were included in the analysis. Four patients (7.5%) in the apixaban group and six patients (10.5%) in the warfarin group met the primary outcome of hospitalization or emergency department visit for stroke (p=0.742). Symptomatic bleeding occurred in 39.6% of patients in the apixaban group and 36.8% in the warfarin group (p=0.918). A trend in major bleeding occurred more often in the warfarin group, 52.4% vs. 49.2% (p=0.758).
CONCLUSIONS: There were no statistically significant differences in efficacy and safety outcomes between apixaban and warfarin in patients with NVAF and ESRD on HD in the intention-to-treat analysis of our study. Larger trials are needed to further analyze this patient population.
PMID:38151201 | DOI:10.1016/j.japh.2023.12.020