RENal hemodialysis patients ALlocated apixaban versus warfarin in Atrial Fibrillation - RENAL-AF
Contribution To Literature:
The RENAL-AF trial showed that apixaban 5 mg BID results in similar rates of bleeding and strokes as warfarin among patients with end-stage renal disease on hemodialysis.
The goal of the trial was to assess the safety and efficacy of apixaban for stroke prophylaxis among patients with atrial fibrillation (AF) and end-stage renal disease on hemodialysis.
Eligible patients were randomized in a 1:1 fashion to either apixaban 5 mg BID (29% received 2.5 mg BID) (n = 82) or warfarin with international normalized ratio (INR) goal 2-3 (n = 72). Time in therapeutic range (TTR) for warfarin: 44.3%.
- Total number of enrollees: 154
- Duration of follow-up: 1 year
- Mean patient age: 69 years
- Percentage female: 35%
- CHA2DS2-VASc score ≥2
- End-stage renal disease on hemodialysis
- Candidate for oral anticoagulant
- Moderate or severe mitral stenosis
- Oral anticoagulant for non-AF indication
- Need for aspirin >81 mg
- Need for dual antiplatelet therapy
- Life-expectancy <3 months
Other salient features/characteristics:
- Median CHA2DS2-VASc score: 4.0
- Prior stroke: 19%
- Prior bleeding: 21%
- Aspirin: 40%
The primary outcome of clinically relevant nonmajor bleed, for apixaban vs. warfarin, was: 31.5% vs. 25.5% (p > 0.05).
Secondary outcomes for apixaban vs. placebo:
- Intracranial bleeding: 1.2% vs. 1.4%; gastrointestinal bleeding: 2.4% vs. 8.3%
- International Society on Thrombosis and Haemostasis (ISTH) major bleed: 8.5% vs. 9.7%
- Stroke: 2.4% vs. 2.8%
- Cardiovascular death: 11% vs. 5.6%
The results of this trial indicate that apixaban 5 mg BID results in similar rates of bleeding and strokes as warfarin among patients with end-stage renal disease on hemodialysis. Some important features of this trial: The trial was stopped early due to loss of funding (originally powered to enroll 760 patients). TTR with warfarin was only approximately 44%, with a large proportion of patients in the subtherapeutic range. It remains unclear if lower apixaban dose (2.5 mg BID) and cessation of aspirin (used in ~40%) would have resulted in lower bleeding compared with warfarin.
Presented by Sean D. Pokorney at the American Heart Association Annual Scientific Sessions (AHA 2019), Philadelphia, PA, November 16, 2019.
Keywords: AHA19, AHA Annual Scientific Sessions, Anticoagulants, Aspirin, Atrial Fibrillation, Hemorrhage, Hemostasis, Kidney Failure, Chronic, Primary Prevention, Renal Dialysis, Stroke, Thrombosis, Warfarin
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