Rivaroxaban Versus Enoxaparin for Thromboprophylaxis After major Gynecological Cancer Surgery: The VALERIA Trial : V enous thromboembolism prophyl A xis after gyneco L ogical p E lvic cancer surgery with RI varoxaban versus enox A parin (VALERIA trial).
André Luiz Malavasi Longo de OliveiraRenata Fernanda de Oliveira PereiraLeandro Barile AgatiCamilla Moreira RibeiroGabrielly Yukimi Kawamura SuguiuraClaudia Helena CioniMarilsa BermudezMárcia Bermudez PiraniRoberto Augusto CaffaroValter CastelliValéria Cristina Resende AguiarGiuliano Giova VolpianiAdilson PaschoaAriane Vieira Scarlatelli MacedoPedro Gabriel Melo de Barros E SilvaJoão Carlos de Campos GuerraJawed FareedRenato Delascio LopesEduardo RamacciottiPublished in: Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis (2022)
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.
Keyphrases
- venous thromboembolism
- direct oral anticoagulants
- end stage renal disease
- atrial fibrillation
- minimally invasive
- ejection fraction
- chronic kidney disease
- patients undergoing
- papillary thyroid
- newly diagnosed
- prognostic factors
- physical activity
- clinical trial
- randomized controlled trial
- phase iii
- study protocol
- phase ii
- lymph node metastasis
- open label
- childhood cancer
- surgical site infection