A Randomized Controlled Trial Comparing Apixaban With the Vitamin K Antagonist Phenprocoumon in Patients on Chronic Hemodialysis: The AXADIA-AFNET 8 Study.
Humans
Female
Aged
Male
Phenprocoumon
/ therapeutic use
Atrial Fibrillation
/ drug therapy
Prospective Studies
Anticoagulants
/ adverse effects
Stroke
/ prevention & control
Hemorrhage
/ chemically induced
Pyridones
/ adverse effects
Renal Dialysis
/ adverse effects
Myocardial Infarction
/ drug therapy
Treatment Outcome
atrial fibrillation
randomized controlled trial
renal dialysis
stroke
Journal
Circulation
ISSN: 1524-4539
Titre abrégé: Circulation
Pays: United States
ID NLM: 0147763
Informations de publication
Date de publication:
24 Jan 2023
24 Jan 2023
Historique:
pubmed:
7
11
2022
medline:
26
1
2023
entrez:
6
11
2022
Statut:
ppublish
Résumé
Non-vitamin K oral anticoagulants have become the standard therapy for preventing stroke and ischemic thromboembolism in most patients with atrial fibrillation (AF). The effectiveness and safety of non-vitamin K oral anticoagulants in patients on hemodialysis is not well known. From June 2017 through May 2022, AXADIA-AFNET 8 (Compare Apixaban and Vitamin K Antagonists in Patients With Atrial Fibrillation and End-Stage Kidney Disease), an investigator-initiated PROBE (prospective randomized open blinded end point) outcome assessment trial, randomized patients with AF on chronic hemodialysis to either apixaban (2.5 mg BID) or the vitamin K antagonist (VKA) phenprocoumon (international normalized ratio, 2.0 to 3.0). The composite primary safety outcome was defined by a first event of major bleeding, clinically relevant nonmajor bleeding, or all-cause death. The primary efficacy outcome was a composite of ischemic stroke, all-cause death, myocardial infarction, and deep vein thrombosis or pulmonary embolism. Our hypothesis was that apixaban is noninferior to VKA. Thirty-nine sites randomized 97 patients (30% women; mean age 75 years; mean CHA In this randomized trial comparing apixaban and VKA in patients with AF on hemodialysis with long follow-up, no differences were observed in safety or efficacy outcomes. Even on oral anticoagulation, patients with AF on hemodialysis remain at high risk of cardiovascular events. Larger randomized trials are needed to determine the optimal anticoagulation regimen for patients with AF on hemodialysis. URL: https://www. gov; Unique identifier: NCT02933697.
Sections du résumé
BACKGROUND
BACKGROUND
Non-vitamin K oral anticoagulants have become the standard therapy for preventing stroke and ischemic thromboembolism in most patients with atrial fibrillation (AF). The effectiveness and safety of non-vitamin K oral anticoagulants in patients on hemodialysis is not well known.
METHODS
METHODS
From June 2017 through May 2022, AXADIA-AFNET 8 (Compare Apixaban and Vitamin K Antagonists in Patients With Atrial Fibrillation and End-Stage Kidney Disease), an investigator-initiated PROBE (prospective randomized open blinded end point) outcome assessment trial, randomized patients with AF on chronic hemodialysis to either apixaban (2.5 mg BID) or the vitamin K antagonist (VKA) phenprocoumon (international normalized ratio, 2.0 to 3.0). The composite primary safety outcome was defined by a first event of major bleeding, clinically relevant nonmajor bleeding, or all-cause death. The primary efficacy outcome was a composite of ischemic stroke, all-cause death, myocardial infarction, and deep vein thrombosis or pulmonary embolism. Our hypothesis was that apixaban is noninferior to VKA.
RESULTS
RESULTS
Thirty-nine sites randomized 97 patients (30% women; mean age 75 years; mean CHA
CONCLUSIONS
CONCLUSIONS
In this randomized trial comparing apixaban and VKA in patients with AF on hemodialysis with long follow-up, no differences were observed in safety or efficacy outcomes. Even on oral anticoagulation, patients with AF on hemodialysis remain at high risk of cardiovascular events. Larger randomized trials are needed to determine the optimal anticoagulation regimen for patients with AF on hemodialysis.
REGISTRATION
BACKGROUND
URL: https://www.
CLINICALTRIALS
RESULTS
gov; Unique identifier: NCT02933697.
Identifiants
pubmed: 36335915
doi: 10.1161/CIRCULATIONAHA.122.062779
pmc: PMC9875840
doi:
Substances chimiques
Phenprocoumon
Q08SIO485D
apixaban
3Z9Y7UWC1J
Anticoagulants
0
Pyridones
0
Banques de données
ClinicalTrials.gov
['NCT02933697']
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
296-309Commentaires et corrections
Type : CommentIn
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