Key result
Male sex was not associated with a significantly different risk of recurrent venous thromboembolism (HR 0.83) or major bleeding compared to female sex in real-world patients.
Why the study?
It remains controversial whether sex category is a risk factor for recurrent venous thromboembolism and major bleeding among VTE patients.
Does male sex compared to female sex affect the risk of recurrent VTE and major bleeding in patients with acute symptomatic VTE?
Observational (n=3,027)
Yes
Does male sex compared to female sex affect the risk of recurrent VTE and major bleeding in patients with acute symptomatic VTE?
Hazard Ratio: 0.83 (95% CI 0.63–1.09)
Absolute Event Rate: 7% vs 8.6%
p-value: p=0.17
In a real-world Japanese registry of acute symptomatic VTE patients, there was no significant sex-related difference in the risks for recurrent VTE or major bleeding at 3 years.
BACKGROUND: It remains controversial whether sex category is a risk for recurrent venous thromboembolism (VTE) and major bleeding among VTE patients. METHODS AND RESULTS: The COMMAND VTE Registry is a multicenter registry enrolling 3,027 consecutive acute symptomatic VTE patients from 29 centers in Japan between January 2010 and August 2014. We compared the clinical characteristics and outcomes of men and women. Men accounted for 1,169 (39%) and women 1,858 (61%). Compared with women, men were younger (64.9±14.7 vs. 68.6±15.6 years old, P<0.001), more often had prior VTE (7.2% vs. 5.1%, P=0.02), and less often had transient risk factors for VTE (30% vs. 40%, P<0.001). The proportions of active cancer and pulmonary embolism were comparable between men and women (24% vs. 22%, P=0.26; 56% vs. 57%, P=0.48, respectively). The cumulative 3-year incidences of recurrent VTE, major bleeding, and all-cause death were not significantly different between men and women (7.0% vs. 8.6%, P=0.47; 10.6% vs. 9.2%, P=0.25; 25.2% vs. 23.4%, P=0.35, respectively). The adjusted risks of men relative to women for recurrent VTE and for major bleeding remained insignificant (HR 0.83, 95% CI 0.63-1.09, P=0.17; HR 1.15, 95% CI 0.90-1.47, P=0.25, respectively). CONCLUSIONS: In real-world VTE patients, the clinical characteristics differed between men and women, but there was not a large sex-related difference in the risks for recurrent VTE or major bleeding.
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Yoshikawa et al. (2019) conducted an observational in Venous Thromboembolism (n=3,027). Male sex vs. Female sex was evaluated on Recurrent VTE (HR 0.83, 95% CI 0.63-1.09, p=0.17). Male sex was not associated with a significantly different risk of recurrent venous thromboembolism (HR 0.83) or major bleeding compared to female sex in real-world patients.
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