Author + information
- Nhu Quyen Dau,
- Maryam Bayat and
- Miguel Salazar
Background: In January 2014, the Food and Drug Administration approved a labeling change for apixaban to include patients on dialysis. Per new labeling, no dose adjustment is recommended in patients with end stage renal disease maintained on intermittent hemodialysis. However, a reduced dose is recommended if patient has one of the two criteria: age ≥80 or body weight ≤60 kg. This dosing recommendation was based on pharmacokinetic and pharmacodynamic data in 8 subjects on dialysis. Thus, it is unknown if bleeding risk increases in this patient population.
Methods: This was a retrospective, single-site, chart review based investigation of dialysis patients on apixaban. The primary objective of this study was to assess the incidence of major bleeding while the patient remained on apixaban.
Results: Thirty patient charts were reviewed. The average age of the patients was 68±11 years old. Atrial fibrillation was the most common indication for apixaban (77%). Twenty-nine patients were on hemodialysis, and one patient was on continuous renal replacement therapy. The incidence of major bleeding as defined by the International Society on Thrombosis and Haemostasis was 13.3%. All bleeders were on appropriate dose as defined by the manufacturer. The bleeder group had higher average HASBLED score compared to non-bleeder group (4.5 versus 3.6). The duration for apixaban use was unknown. No thromboembolic event was reported. Two deaths occurred and none was attributed to apixaban use.
Conclusions: In the present analysis, we have provided real-life data on the safety of apixaban in patients on dialysis. The study is limited by sample size, but given the 13.3% incidence of major bleeding events, caution should be exercised when apixaban is prescribed for patients on hemodialysis.
Poster Hall, Hall C
Saturday, March 18, 2017, 9:45 a.m.-10:30 a.m.
Session Title: Arrhythmias and Clinical EP: Anticoagulation Issues
Abstract Category: 6. Arrhythmias and Clinical EP: Other
Presentation Number: 1189-083
- 2017 American College of Cardiology Foundation