Arrhythmias & electrophysiologySecondary analysis
Apixaban Versus Warfarin in Patients With Atrial Fibrillation and Advanced Chronic Kidney Disease
- Secondary analysis of the ARISTOTLE randomised trial
- subgroup analysis
- pharmacokinetic analysis
Authors' conclusion
Among patients with atrial fibrillation and CrCl 25 to 30 mL/min, apixaban caused less bleeding than warfarin, with even greater reductions in bleeding than in patients with CrCl >30 mL/min.
Study context
- Population
- Patients with AF and advanced CKD (CrCl 25 to 30 mL/min) enrolled in ARISTOTLE
- Participants
- 269 patients
- Comparison
- Apixaban vs warfarin
- Primary endpoint
- Major bleeding; major or clinically relevant nonmajor bleeding
Primary result
As reported in the abstract
Bleeding, CrCl 25 to 30 mL/min
Apixaban vs WarfarinHazard ratio (95% CI)
major bleeding
0.34(0.14–0.80)
major or clinically relevant nonmajor bleeding
0.35(0.17–0.72)
Further findings
Apixaban steady-state daily AUC (exposure)
Bleeding with apixaban, CrCl 25 to 30 vs >30 mL/min
- Trend toward lower major bleeding with CrCl 25 to 30 mL/min
- P for interaction = 0.08
- Trend toward lower major or clinically relevant nonmajor bleeding with CrCl 25 to 30 mL/min
- P for interaction = 0.05
Apixaban steady-state daily AUC (exposure)
- AUC values with CrCl 25 to 30 mL/min fell within the ranges for CrCl >30 mL/min
Original publication
Apixaban Versus Warfarin in Patients With Atrial Fibrillation and Advanced Chronic Kidney Disease. Circulation. Published 12 March 2020. doi:10.1161/circulationaha.119.044059
Summarised from the published abstract; every number is checked against it