Category: Federal Forum Posters
Purpose: Apixaban is the only direct oral anticoagulant approved for use in patients with end-stage renal disease (ESRD). This approval was based on evidence from a small pharmacokinetic study demonstrating similar plasma concentration and pharmacodynamic activity of reduced-dose apixaban in ESRD patients compared to full-dose apixaban in patients with preserved renal function. It is still unknown whether these pharmacokinetic similarities correlate with a similar stroke reduction and bleeding risk in patients with ESRD. This study will be one of the largest retrospective reviews analyzing clinical outcomes of apixaban use in Veterans with ESRD across the United States.
Methods: This study is an institutional review board and research and development approved, case-control retrospective database analysis. National data will be collected utilizing the Veterans Affairs Corporate Data Warehouse to identify patients receiving anticoagulation therapy with apixaban (study group) or warfarin (control group) between June 1, 2014 and May 31, 2018. Patients on apixaban will be matched to those on warfarin in a 1:2 fashion. The study population will include patients 18 years of age or older with ESRD, defined as creatinine clearance less than or equal to 15 mL/min for at least 3 months or on dialysis. Patients will be excluded if they are on long-term injectable anticoagulation, receiving direct oral anticoagulants other than apixaban, or have a spinal cord injury. The primary objective is to identify the difference in bleeding rates for patients with ESRD on apixaban compared to warfarin. The secondary endpoints will identify differences in rates of venous thromboembolism (VTE) and the differences in rates of bleeding and VTE based on therapeutic indication. Planned statistical analysis includes t-test and chi-square test, based on variable type, to evaluate overall incidence of bleeding events, thrombotic events, and differences in cohort demographics.
Results: Not applicable
Conclusion: Not applicable
Emily McElhaney– PGY1 Pharmacy Resident, James A. Haley Veterans' Hospital, Tampa, FL