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:
Compare Apixaban and Vitamin K Antagonists AF documented on ≥2 electrocardiograms at different days
in Patients With Atrial Fibrillation and End- Increased stroke risk estimated by CHA2DS2-VASc score ≥2
Age ≥18 years
Stage Kidney Disease - AXADIA-AFNET 8
Exclusion criteria:
Feb 08, 2023
Stroke within 3 months of enrollment
Hemodialysis for <3 months
Author/Summarized by Dharam J. Kumbhani, MD, SM, FACC Moderate or severe aortic or mitral stenosis
Author: Conditions other than AF requiring anticoagulation
Active endocarditis
Summary Reviewer: Deepak L. Bhatt, MD, MPH, FACC Planned AF or atrial flutter ablation
Trial Sponsor: Bristol Myers Squibb, Pfizer, and Kompetenznetz Active bleeding, serious bleeding <6 months before enrollment
Vorhofflimmern eV. Uncontrolled diabetes
History of cancer
Date Published: 01/24/2023 Need for chronic aspirin therapy
Original Posted Date: 02/08/2023 Other salient features/characteristics:
References No coronary artery disease: 33%
Contribution To Literature: Heart valve disease: 47%
Median CHA2DS2-VASc score: 5
The AXADIA-AFNET 8 trial showed that apixaban did not meet criteria for Median HAS-BLED score: 4
noninferiority compared with VKA for safety and efficacy among patients with AF Days since first dialysis (mean): 1,687 days
on chronic hemodialysis.
Of 48 patients randomized to apixaban, 44 adhered to the intake of medication
Description:
according to protocol; 4 patients missed >20% of the apixaban doses during the
The goal of the trial was to assess the safety and efficacy of apixaban 2.5 mg BID therapy. The median time in target range (TTR) in patients randomized to VKA was
vs. vitamin K antagonist (VKA) among patients with atrial fibrillation (AF) on 50.7%.
chronic hemodialysis. Principal Findings:

Study Design 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.
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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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