RENal hemodialysis patients ALlocated apixaban versus warfarin in Atrial Fibrillation - RENAL-AF

Nov 17, 2019
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Presenter/Author:
Sean Pokorney, MBA, MD
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, FACC
Trial Sponsor:
BMS/Pfizer Alliance
Date Presented:
11/16/2019
Date Updated:
11/17/2019
Original Posted Date:
11/17/2019
References

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.

Description:

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.

Study Design

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%

Inclusion criteria:

  • AF
  • CHA2DS2-VASc score ≥2
  • End-stage renal disease on hemodialysis
  • Candidate for oral anticoagulant

Exclusion criteria:

  • 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%

Principal Findings:

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%

Interpretation:

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.

References:

Presented by Sean D. Pokorney at the American Heart Association Annual Scientific Sessions (AHA 2019), Philadelphia, PA, November 16, 2019.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Prevention, Anticoagulation Management and Atrial Fibrillation, Atrial Fibrillation/Supraventricular Arrhythmias

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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