Sex differences in clinical characteristics, management, and outcomes in patients with venous thromboembolism in the direct oral anticoagulant era: Insight from the COMMAND VTE Registry-2

Introduction: Sex-specific differences in the prognosis of venous thromboembolism (VTE) remain controversial, particularly in the current era of widespread use of direct oral anticoagulants. Real-world management and outcomes of VTE stratified by sex were investigated in a nationwide registry. Methods: The COMMAND VTE Registry-2 is a multicenter registry that enrolled 5197 consecutive acute symptomatic VTE patients from 31 centers in Japan between January 2015 and August 2020. In this cohort, baseline characteristics, anticoagulation strategies, and long-term clinical outcomes were compared between men and women. Multivariable Cox proportional hazards models were used to estimate adjusted hazard ratios for clinical outcomes. Results: The study population consisted of 2134 men (41.1 %) and 3063 women (58.9 %). Compared with women, men were younger (mean age ± standard deviation, 66.1 ± 14.7 vs. 68.9 ± 16.2 years, P < 0.001), more frequently had active cancer (31.1 % vs. 27.6 %, P = 0.006), and were less likely to present with transient risk factors (32.4 % vs. 40.5 %, P < 0.001). Pulmonary embolism was more common in men (56.7 % vs. 51.5 %, P < 0.001). There were no significant differences in the cumulative 5-year incidences of recurrent VTE or major bleeding between men and women (7.3 % vs. 7.8 %, P = 0.77; 10.8 % vs. 12.4 %, P = 0.20). Although the incidence of all-cause death was higher in men (34.5 % vs. 30.6 %, P = 0.02), this difference was not significant after multivariable adjustment (hazard ratio 1.05, 95 % confidence interval 0.94–1.17, P = 0.39). Conclusion: In this large, multicenter registry, sex was not associated with recurrent thrombosis, major bleeding, or long-term mortality after multivariable adjustment.