Rivaroxaban Versus Enoxaparin for Thromboprophylaxis After major Gynecological Cancer Surgery: The VALERIA Trial enous thromboembolism prophyl
Direct oral anticoagulants (DOACs) for venous thromboembolism (VTE) prevention after major gynecological cancer surgery might be an alternative to parenteral low-molecular-weight heparin (LMWH). Patients undergoing major gynecological cancer surgery were randomized at hospital discharge to receive r...
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Published in | Clinical and applied thrombosis/hemostasis Vol. 28 |
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Main Authors | , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Sage CA: Los Angeles, CA
SAGE Publications
06.12.2022
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Subjects | |
Online Access | Get full text |
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Summary: | Direct oral anticoagulants (DOACs) for venous thromboembolism (VTE) prevention
after major gynecological cancer surgery might be an alternative to parenteral
low-molecular-weight heparin (LMWH). Patients undergoing major gynecological
cancer surgery were randomized at hospital discharge to receive rivaroxaban 10
mg once daily or enoxaparin 40 mg once daily for 30 days. The primary efficacy
outcome was a combination of symptomatic VTE and VTE-related death or
asymptomatic VTE at day 30. The primary safety outcome was the incidence of
major or clinically relevant nonmajor bleeding. Two hundred and twenty-eight
patients were enrolled and randomly assigned to receive rivaroxaban
(n = 114)or enoxaparin (n = 114). The trial was stopped due to a
lower-than-expected event rate. The primary efficacy outcome occurred in 3.51%
of patients assigned to rivaroxaban and in 4.39% of patients assigned to
enoxaparin (relative risk 0.80, 95% CI 0.22 to 2.90; p = 0.7344). Patients
assigned to rivaroxaban had no primary bleeding event, and 3 patients (2.63%) in
the enoxaparin group had a major or CRNM bleeding event (hazard ratio, 0.14; 95%
CI, 0.007 to 2.73; P = 0.1963). In patients undergoing major gynecological
cancer surgery, thromboprophylaxis with rivaroxaban 10 mg daily for 30 days had
similar rates of thrombotic and bleeding events compared to parenteral
enoxaparin 40 mg daily. While the power is limited due to not reaching the
intended sample size, our results support the hypothesis that DOACs might be an
attractive alternative strategy to LMWH to prevent VTE in this high-risk
population. |
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Bibliography: | This article has not been presented anywhere. This article has not been published. |
ISSN: | 1076-0296 1938-2723 |
DOI: | 10.1177/10760296221132556 |