Impact of gender: Rivaroxaban for patients with atrial fibrillation in the XANTUS real-world prospective study.
Aged
Atrial Fibrillation
/ complications
Dose-Response Relationship, Drug
Europe
/ epidemiology
Factor Xa Inhibitors
/ administration & dosage
Female
Humans
Incidence
Male
Prospective Studies
Risk Assessment
/ methods
Risk Factors
Rivaroxaban
/ administration & dosage
Sex Distribution
Sex Factors
Survival Rate
/ trends
Thromboembolism
/ epidemiology
anticoagulant
atrial fibrillation
real-world evidence
stroke
Journal
Clinical cardiology
ISSN: 1932-8737
Titre abrégé: Clin Cardiol
Pays: United States
ID NLM: 7903272
Informations de publication
Date de publication:
Dec 2020
Dec 2020
Historique:
received:
03
02
2020
revised:
04
08
2020
accepted:
06
08
2020
pubmed:
9
9
2020
medline:
10
8
2021
entrez:
8
9
2020
Statut:
ppublish
Résumé
The XANTUS study (NCT01606995) demonstrated low rates of stroke and major bleeding in patients with atrial fibrillation (AF) receiving rivaroxaban in clinical practice for the prevention of thromboembolic events (N = 6784). Because previous real-world studies have not reported gender-dependent responses to rivaroxaban treatment, this sub-analysis of the XANTUS study investigated the effect of gender on outcomes. The centrally adjudicated outcomes were compared between genders. Primary outcomes were major bleeding and all-cause death. Secondary outcomes included symptomatic thromboembolic events. Multivariable Cox regression analysis was performed to assess the effect of risk factors on outcomes between genders. A total of 2765 female and 4016 male patients were included in the analysis. Baseline characteristics were generally similar. No nominally significant interaction between gender and risk factors for the study outcomes was observed. Rates of major bleeding, all-cause death and symptomatic thromboembolic events in patients with non-valvular AF receiving rivaroxaban for stroke prevention were similar in men and women; no significant differences in risk factors for these outcomes were observed between genders. Further research is needed to better characterize the relative importance of different risk factors on outcomes in men vs women and to determine whether gender differences exist in patients treated with non-vitamin K antagonist oral anticoagulants.
Sections du résumé
BACKGROUND
BACKGROUND
The XANTUS study (NCT01606995) demonstrated low rates of stroke and major bleeding in patients with atrial fibrillation (AF) receiving rivaroxaban in clinical practice for the prevention of thromboembolic events (N = 6784).
HYPOTHESIS
OBJECTIVE
Because previous real-world studies have not reported gender-dependent responses to rivaroxaban treatment, this sub-analysis of the XANTUS study investigated the effect of gender on outcomes.
METHODS
METHODS
The centrally adjudicated outcomes were compared between genders. Primary outcomes were major bleeding and all-cause death. Secondary outcomes included symptomatic thromboembolic events. Multivariable Cox regression analysis was performed to assess the effect of risk factors on outcomes between genders.
RESULTS
RESULTS
A total of 2765 female and 4016 male patients were included in the analysis. Baseline characteristics were generally similar. No nominally significant interaction between gender and risk factors for the study outcomes was observed. Rates of major bleeding, all-cause death and symptomatic thromboembolic events in patients with non-valvular AF receiving rivaroxaban for stroke prevention were similar in men and women; no significant differences in risk factors for these outcomes were observed between genders.
CONCLUSIONS
CONCLUSIONS
Further research is needed to better characterize the relative importance of different risk factors on outcomes in men vs women and to determine whether gender differences exist in patients treated with non-vitamin K antagonist oral anticoagulants.
Identifiants
pubmed: 32896928
doi: 10.1002/clc.23452
pmc: PMC7724214
doi:
Substances chimiques
Factor Xa Inhibitors
0
Rivaroxaban
9NDF7JZ4M3
Types de publication
Comparative Study
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1405-1413Subventions
Organisme : Bayer
Organisme : Janssen Research and Development
Informations de copyright
© 2020 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.
Références
Vasc Health Risk Manag. 2014 Jul 17;10:425-34
pubmed: 25083135
Eur Heart J. 2016 Apr 7;37(14):1145-53
pubmed: 26330425
Arch Intern Med. 1995 Mar 13;155(5):469-73
pubmed: 7864703
QJM. 2014 Dec;107(12):955-67
pubmed: 24633256
Clin Cardiol. 2020 Dec;43(12):1405-1413
pubmed: 32896928
Eur Heart J. 2015 Dec 7;36(46):3258-64
pubmed: 26424865
Lancet. 2015 Jul 11;386(9989):154-62
pubmed: 25960110
Circulation. 2014 Feb 25;129(8):837-47
pubmed: 24345399
Chest. 2010 Feb;137(2):263-72
pubmed: 19762550
BMJ Open. 2017 Mar 6;7(3):e014579
pubmed: 28264833
Heart. 2017 Jul;103(13):1024-1030
pubmed: 28228467
J Thromb Haemost. 2005 Apr;3(4):692-4
pubmed: 15842354
Arch Intern Med. 2004 Jul 12;164(13):1422-6
pubmed: 15249351
BMJ. 2016 Jan 19;532:h7013
pubmed: 26786546
Clin Epidemiol. 2014 Jun 16;6:213-20
pubmed: 24966695
Circulation. 2017 Feb 7;135(6):593-608
pubmed: 28153995
Chest. 2010 Nov;138(5):1093-100
pubmed: 20299623
J Am Coll Cardiol. 2014 Mar 11;63(9):891-900
pubmed: 24315894
Chest. 2013 Nov;144(5):1555-1563
pubmed: 23669885
Eur Heart J. 2016 Oct 7;37(38):2893-2962
pubmed: 27567408
JAMA Cardiol. 2016 Jun 1;1(3):282-91
pubmed: 27438106
Am J Cardiol. 2016 Mar 15;117(6):1021-7
pubmed: 26923085
Am J Cardiol. 2014 Feb 1;113(3):485-90
pubmed: 24315113
J Am Coll Cardiol. 2014 May 27;63(20):2141-2147
pubmed: 24657685
J Am Coll Cardiol. 2011 Jul 19;58(4):395-401
pubmed: 21757117
Stroke. 2017 Mar;48(3):778-780
pubmed: 28151397