Rivaroxaban Versus Enoxaparin for Thromboprophylaxis After major Gynecological Cancer Surgery: The VALERIA Trial

Autor: André Luiz Malavasi Longo de Oliveira MD, MSc, Renata Fernanda de Oliveira Pereira MD, Leandro Barile Agati Ph.D, Camilla Moreira Ribeiro Ph.D, Gabrielly Yukimi Kawamura Suguiura, Claudia Helena Cioni MD, Marilsa Bermudez MD, Márcia Bermudez Pirani MD, Roberto Augusto Caffaro MD, Ph.D, Valter Castelli, Valéria Cristina Resende Aguiar MD, Giuliano Giova Volpiani MD, Adilson Paschoa MD, Ph.D, Ariane Vieira Scarlatelli Macedo MD, Pedro Gabriel Melo de Barros e Silva MD, Ph.D, João Carlos de Campos Guerra MD, Ph.D, Jawed Fareed Ph.D, Renato Delascio Lopes MD, Ph.D, Eduardo Ramacciotti MD, Ph.D
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Clinical and Applied Thrombosis/Hemostasis, Vol 28 (2022)
Druh dokumentu: article
ISSN: 1938-2723
10760296
77352661
DOI: 10.1177/10760296221132556
Popis: 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.
Databáze: Directory of Open Access Journals
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