RENAL-AF trial: Apixaban similar to warfarin

The RENAL-AF trial showed that apixaban 5 mg twice daily results in similar rates of bleeding and stroke as warfarin among patients with end-stage renal disease on haemodialysis.

This randomised controlled trial assessed the safety and efficacy of apixaban as a means for stroke prophylaxis among patients with atrial fibrillation (AF) and end-stage renal disease on haemodialysis, but it was terminated early due to slow enrolment. Dr Sean Pokorney (Duke Clinical Research Institute, USA) presented the interim trial results, which included data on 154 patients with AF and end-stage renal disease who received renal replacement therapy by haemodialysis and who were candidates for oral anticoagulants. Patients were randomised to either apixaban 5 mg twice daily (n=82; 29% received 2.5 mg twice daily) or warfarin (n=72). The mean age of patients in both arms was 69 years; 35% were female. Nearly 20% of the patients had suffered a prior stroke.

The primary outcome was clinically relevant non-major bleeding, which occurred in 31.5% of patients receiving apixaban versus 25.5% receiving warfarin (P>0.05). Secondary outcomes were intracranial bleeding rates (1.2% apixaban vs 1.4% warfarin), gastrointestinal bleeding (2.4% apixaban vs 8.3% warfarin), ISTH major bleeding (8.5% apixaban vs 9.7% warfarin), stroke (2.4% apixaban vs 2.8% warfarin), and cardiovascular death (11% apixaban vs 5.6% warfarin).

In conclusion, the results of this trial indicate that apixaban 5 mg twice daily results in similar rates of bleeding and stroke compared with warfarin among patients with end-stage renal disease on haemodialysis. Unique to this trial is the fact that 44.9% of the patients included in RENAL-AF were of African-American descent, making this the only oral anticoagulant trial with a significant minority cohort. Ongoing pharmacokinetic analyses may provide new data that could help guide apixaban dose selection in this high-risk population.

1. Pokorney SD, et al. Apixaban versus warfarin for strike prevention in patients with end stage renal disease on hemodialysis and atrial fibrillation: results of a randomized clinical trial assessing safety. FS.AOS.04, AHA Scientific Sessions 2019, 14-18 November, Philadelphia, USA.