Efficacy and safety of apixaban vs warfarin in patients with atrial fibrillation and prior bioprosthetic valve replacement or valve repair: Insights from the ARISTOTLE trial.
Aged
Anticoagulants
/ adverse effects
Atrial Fibrillation
/ complications
Bioprosthesis
Factor Xa Inhibitors
/ adverse effects
Female
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation
/ adverse effects
Heart Valves
/ surgery
Hemorrhage
/ chemically induced
Humans
Male
Middle Aged
Pyrazoles
/ adverse effects
Pyridones
/ adverse effects
Risk Factors
Stroke
/ diagnosis
Time Factors
Treatment Outcome
Warfarin
/ adverse effects
apixaban
atrial fibrillation
bioprosthetic valves
valve repair
Journal
Clinical cardiology
ISSN: 1932-8737
Titre abrégé: Clin Cardiol
Pays: United States
ID NLM: 7903272
Informations de publication
Date de publication:
May 2019
May 2019
Historique:
received:
14
02
2019
accepted:
22
03
2019
pubmed:
25
3
2019
medline:
19
12
2019
entrez:
26
3
2019
Statut:
ppublish
Résumé
The optimal anticoagulation strategy for patients with atrial fibrillation (AF) and bioprosthetic valve (BPV) replacement or native valve repair remains uncertain. We evaluated the safety and efficacy of apixaban vs warfarin in patients with AF and a history of BPV replacement or native valve repair. Using data from Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) (n = 18 201), a randomized trial comparing apixaban with warfarin in patients with AF, we analyzed the subgroup of patients (n = 251) with prior valve surgery. We contacted sites by telephone to obtain additional data about prior valve surgery. Full data were available for 156 patients. The primary efficacy endpoint was stroke/systemic embolism. The primary safety endpoint was major bleeding. Treatment groups were compared using a Cox regression model. In ARISTOTLE, 104 (0.6%) patients had a history of BPV replacement (n = 73 [aortic], n = 26 [mitral], n = 5 [mitral and aortic]) and 52 (0.3%) had a history of valve repair (n = 50 [mitral], n = 2 [aortic]). Among patients with BPVs, 55 were randomized to apixaban and 49 to warfarin. Among those with a history of native valve repair, 32 were randomized to apixaban and 20 to warfarin. Overall clinical event rates were low, with no significant differences between apixaban and warfarin for any outcomes. In patients with AF and a history of BPV replacement or repair, the safety and efficacy of apixaban compared with warfarin was consistent with results from ARISTOTLE. These data suggest that apixaban may be reasonable for patients with BPVs or prior valve repair, though future larger randomized trials are needed. CLINICALTRIALS.GOV: NCT00412984.
Sections du résumé
BACKGROUND
BACKGROUND
The optimal anticoagulation strategy for patients with atrial fibrillation (AF) and bioprosthetic valve (BPV) replacement or native valve repair remains uncertain.
HYPOTHESIS
OBJECTIVE
We evaluated the safety and efficacy of apixaban vs warfarin in patients with AF and a history of BPV replacement or native valve repair.
METHODS
METHODS
Using data from Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) (n = 18 201), a randomized trial comparing apixaban with warfarin in patients with AF, we analyzed the subgroup of patients (n = 251) with prior valve surgery. We contacted sites by telephone to obtain additional data about prior valve surgery. Full data were available for 156 patients. The primary efficacy endpoint was stroke/systemic embolism. The primary safety endpoint was major bleeding. Treatment groups were compared using a Cox regression model.
RESULTS
RESULTS
In ARISTOTLE, 104 (0.6%) patients had a history of BPV replacement (n = 73 [aortic], n = 26 [mitral], n = 5 [mitral and aortic]) and 52 (0.3%) had a history of valve repair (n = 50 [mitral], n = 2 [aortic]). Among patients with BPVs, 55 were randomized to apixaban and 49 to warfarin. Among those with a history of native valve repair, 32 were randomized to apixaban and 20 to warfarin. Overall clinical event rates were low, with no significant differences between apixaban and warfarin for any outcomes.
CONCLUSIONS
CONCLUSIONS
In patients with AF and a history of BPV replacement or repair, the safety and efficacy of apixaban compared with warfarin was consistent with results from ARISTOTLE. These data suggest that apixaban may be reasonable for patients with BPVs or prior valve repair, though future larger randomized trials are needed. CLINICALTRIALS.GOV: NCT00412984.
Identifiants
pubmed: 30907005
doi: 10.1002/clc.23178
pmc: PMC6522998
doi:
Substances chimiques
Anticoagulants
0
Factor Xa Inhibitors
0
Pyrazoles
0
Pyridones
0
apixaban
3Z9Y7UWC1J
Warfarin
5Q7ZVV76EI
Banques de données
ClinicalTrials.gov
['NCT00412984']
Types de publication
Comparative Study
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
568-571Subventions
Organisme : Bristol-Myers Squibb
Organisme : Pfizer
Informations de copyright
© 2019 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.
Références
Clin Cardiol. 2019 May;42(5):568-571
pubmed: 30907005
Eur Heart J. 2014 Dec 14;35(47):3328-35
pubmed: 25265975
Circulation. 2015 Aug 25;132(8):624-32
pubmed: 26106009
N Engl J Med. 2011 Sep 15;365(11):981-92
pubmed: 21870978
Circulation. 2017 Mar 28;135(13):1273-1275
pubmed: 28209729
Circulation. 2017 Feb 14;135(7):714-716
pubmed: 28193802