Category: Federal Forum Posters
Purpose: Risk of thrombus is heightened in end-stage renal disease (ESRD). Although ESRD is common in clinical practice, it is often underrepresented in clinical trials of warfarin versus direct oral anticoagulants (DOACs). Excluding severe renal impairment makes it difficult to strongly recommend DOACs in this population. Apixaban has been prescribed for patients on dialysis at the Atlanta Veteran Affairs (VA) Health Care System. The VA Pharmacy Benefits Management criteria for use cautions and restricts apixaban in this population. The objective of this study is to determine the safety and efficacy of apixaban compared to warfarin in dialysis patients.
Methods: This study will be submitted to the Institutional Review Board for approval. Actions will be taken to ensure patient confidentiality is maintained and patients will be assigned generic study letters and numbers. International Classification of Diseases (ICD) 9 and 10 codes will be used to recruit patients for this retrospective chart review. An equally matched number of adult patients greater than or equal to 18-years old with a diagnosis of ESRD on either apixaban or warfarin between January 1, 2014 and July 31, 2018 will be included. Anticoagulation for post-operative indications will be excluded. The primary outcome of this study is overall bleeding event rate which will be defined as a bleeding event after at least 2 doses of apixaban or 5 doses of warfarin while inpatient or after receiving at least 1 prescription while outpatient. Secondary outcomes will include major bleeding events, clinically relevant non-major bleeding events, minor bleeding, new or recurrent venous thromboembolism or ischemic stroke. Major bleeding will be defined using the International Society on Thrombosis and Haemostasis criteria. Clinical and demographic data will be collected and the appropriate statistical tests will be executed to analyze the data.
Results: Not applicable.
Conclusion: Not applicable.
Odirichukwu Duru– PGY1 Pharmacy Resident, Atlanta VA Health Care System, Benicia, CA