Why the study?
Previous real-world studies had not reported gender-dependent responses to rivaroxaban treatment in patients with AF.
Does gender affect the rates of major bleeding, all-cause death, and thromboembolic events in patients with non-valvular atrial fibrillation receiving rivaroxaban?
Does gender affect the rates of major bleeding, all-cause death, and thromboembolic events in patients with non-valvular atrial fibrillation receiving rivaroxaban?
Gender does not appear to significantly affect the rates of major bleeding, all-cause death, or thromboembolic events in patients with non-valvular atrial fibrillation treated with rivaroxaban in routine clinical practice.
Similar event rates by gender support consistent rivaroxaban use in AF; leaves open gender-specific risk factor effects or differences with other agents.
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: 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: 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: 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: 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.
No takes yet. Share an insight, caveat, or question.
Camm et al. (2020) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: