Compare Apixaban and Vitamin K Antagonists in Patients With Atrial Fibrillation and End-Stage Kidney Disease - AXADIA-AFNET 8

Feb 08, 2023
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Bristol Myers Squibb, Pfizer, and Kompetenznetz Vorhofflimmern eV.
Date Published:
01/24/2023
Original Posted Date:
02/08/2023
References

Contribution To Literature:

The AXADIA-AFNET 8 trial showed that apixaban did not meet criteria for noninferiority compared with VKA for safety and efficacy among patients with AF on chronic hemodialysis.

Description:

The goal of the trial was to assess the safety and efficacy of apixaban 2.5 mg BID vs. vitamin K antagonist (VKA) among patients with atrial fibrillation (AF) on chronic hemodialysis.

Study Design

Patients were randomized in a 1:1 fashion to an oral anticoagulant with either apixaban 2.5 mg BID (n = 48) or phenprocoumon international normalized ratio (INR) goal 2-3 (n = 49).

  • Total number of enrollees: 97
  • Duration of follow-up: 429 days
  • Mean age: 75 years
  • Percentage female: 30%

Inclusion criteria:

  • AF documented on ≥2 electrocardiograms at different days
  • Increased stroke risk estimated by CHA2DS2-VASc score ≥2
  • Age ≥18 years

Exclusion criteria:

  • Stroke within 3 months of enrollment
  • Hemodialysis for <3 months
  • Moderate or severe aortic or mitral stenosis
  • Conditions other than AF requiring anticoagulation
  • Active endocarditis
  • Planned AF or atrial flutter ablation
  • Active bleeding, serious bleeding <6 months before enrollment
  • Uncontrolled diabetes
  • History of cancer
  • Need for chronic aspirin therapy

Other salient features/characteristics:

  • No coronary artery disease: 33%
  • Heart valve disease: 47%
  • Median CHA2DS2-VASc score: 5
  • Median HAS-BLED score: 4
  • Days since first dialysis (mean): 1,687 days

Of 48 patients randomized to apixaban, 44 adhered to the intake of medication according to protocol; 4 patients missed >20% of the apixaban doses during the therapy. The median time in target range (TTR) in patients randomized to VKA was 50.7%.

Principal Findings:

The primary safety endpoint, composite of major bleeding, clinically relevant nonmajor bleeding, or all-cause mortality, for apixaban vs. VKA, was: 45.8% vs. 51% (p = 0.16 for noninferiority, p = 0.40 for superiority).

The primary efficacy endpoint, myocardial infarction (MI), transient ischemic attack (TIA), all-cause death, deep vein thrombosis, or pulmonary embolism, for apixaban vs. VKA, was: 20.8% vs. 30.6% (p = 0.51).

Secondary analyses for apixaban vs. VKA:

  • Major bleeding: 10.4% vs. 12.2% (p = 1.0)
  • Cardiovascular mortality: 14.6% vs. 10.2% (p = 0.55)
  • MI: 4.2% vs. 6.1% (p = 1.0)
  • Shunt thrombosis: 12.5% vs. 6.1% (p = 0.32)

Interpretation:

In this small trial, apixaban did not meet criteria for noninferiority compared with VKA for safety and efficacy among patients with AF on chronic hemodialysis. Rates of bleeding were high in both arms. Results are more or less similar to the RENAL-AF trial, in which both doses of apixaban 2.5 mg and 5 mg BID were utilized.

References:

Reinecke H, Engelbertz C, Bauersachs R, et al. A Randomized Controlled Trial Comparing Apixaban With the Vitamin K Antagonist Phenprocoumon in Patients on Chronic Hemodialysis: The AXADIA-AFNET 8 Study. Circulation 2023;147:296-309.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Geriatric Cardiology, Valvular Heart Disease, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Anticoagulants, Arrhythmias, Cardiac, Atrial Fibrillation, Dialysis, Electrocardiography, Geriatrics, Heart Valve Diseases, Hemorrhage, Ischemic Attack, Transient, Kidney Diseases, Myocardial Infarction, Phenprocoumon, Pulmonary Embolism, Renal Dialysis, Stroke, Thrombosis, Vitamin K


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