Abstract
BackgroundThe 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).HypothesisBecause 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.MethodsThe 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.ResultsA 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.ConclusionsFurther 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.
Highlights
Atrial fibrillation (AF) is a common cardiac arrhythmia.[1]
Of the 6784 patients included in the safety population, 4016 (59.2%), were male and 2765 (40.8%) were female
Because female gender accounted for most of the difference in CHA2DS2-VASc score, it is unlikely that other factors such as age > 75 years contributed substantially to the difference in CHA2DS2-VASc score between men and women
Summary
Atrial fibrillation (AF) is a common cardiac arrhythmia.[1]. Its reported prevalence has increased in recent years, due to the aging population and perhaps partly due to improved detection.[1,2] AF is associated with a 5-fold increase in the risk of stroke. 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). Primary outcomes were major bleeding and all-cause death. No nominally significant interaction between gender and risk factors for the study outcomes was observed. 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: 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
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
