Sex related differences in patients with acute venous thromboembolism treated with new oral anticoagulants. A meta-analysis of the interventional trials

•No significant difference of recurrent VTE was found between men and women.•Compared to men, women with VTE treated with NOACs have a higher risk of bleeding.•Future trials should assess the relationship between gender and NOACs in VTE.

BackgroundGender differences have been reported in patients with acute VTE treated with antithrombotic drugs.ObjectiveTo address the relationship between gender and new oral anticoagulants (NOACs), we performed a meta-analysis to evaluate the incidence of recurrent VTE and major plus clinically relevant non-major bleedings in males and females, with acute VTE, treated with NOACs over the treatment period.DesignSystematic review and meta-analysis of double blind randomized controlled trials (RCTs).Data sourcesMEDLINE, Cochrane Library of Clinical Trials (up to September 2015).Study selectionRCTs that compared the beneficial and harmful effects of NOAC drugs (apixaban, dabigatran, edoxaban and rivaroxaban).Data extractionThree authors abstracted data. Study-specific risk ratios (RR) were combined using random-effects model.ResultsNine studies including 16,372 patients were selected. No significant difference for the incidence of recurrent VTE was found between men and women. Compared to men, women had a higher incidence of major bleedings plus clinically relevant minor bleedings (5.3% and 7.9% respectively; RR: 0.635; 95% CI: 0.54-0.74; p < 0.001). The subgroup analysis showed a significant gender difference in incidence of major bleedings and clinically relevant minor bleedings only for Edoxaban (RR: 0.52; 95% CI: 0.42-0.64; p < 0.001).ConclusionsThis meta-analysis showed, compared to men, a higher risk of bleeding in women with acute VTE treated with NOACs. Future trials should evaluate the effect of gender on bleeding in patients with acute VTE treated with NOACs.