RENAL‑AF: Apixaban vs Warfarin in Hemodialysis + AF
Bottom line
Underpowered. No definitive difference in bleeding: 1‑yr major/CRNM bleeding 31.5% apixaban vs 25.5% warfarin (HR 1.20, 95% CI 0.63–2.30). Stroke/SE were rare (~3% per yr in both). Bleeding events ≈10× strokes/SE in this population on OAC.
Primary endpoint
31.5% vs 25.5%
Apix vs Warf (1‑yr)
Hazard ratio
1.20
95% CI 0.63–2.30
Stroke/SE
3.0% vs 3.3%
Death
26% vs 18%
Methods
- Adults with AF on chronic HD, CHA2DS2-VASc ≥2
- Randomized 1:1 to Apixaban vs Warfarin (INR 2–3)
- Primary: ISTH major or CRNM bleed
- Secondary: Stroke/SE, death, PK substudy
- PROBE design, N=154, stopped early
Primary Outcome
Apixaban Warfarin
1‑yr incidence of major/CRNM bleeding
Strengths
- First randomized trial of apixaban in HD + AF
- Blinded endpoint adjudication
- Largest apixaban PK dataset in this group
Limitations
- Stopped early, underpowered
- Warfarin TTR only 44%
- Few stroke events; efficacy not assessed
- No minor bleeds recorded