Rivaroxaban Versus Enoxaparin for Thromboprophylaxis After major Gynecological Cancer Surgery: The VALERIA Trial
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...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2022-12-01
|
| Series: | Clinical and Applied Thrombosis/Hemostasis |
| Online Access: | https://doi.org/10.1177/10760296221132556 |
| _version_ | 1811178021938266112 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | André Luiz Malavasi Longo de Oliveira MD, MSc |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T06:12:25Z |
| format | Article |
| id | doaj.art-ca4c7735266145b3a83e413a0be1d491 |
| institution | Directory Open Access Journal |
| issn | 1938-2723 |
| language | English |
| last_indexed | 2024-04-11T06:12:25Z |
| publishDate | 2022-12-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Clinical and Applied Thrombosis/Hemostasis |
| spelling | doaj.art-ca4c7735266145b3a83e413a0be1d4912022-12-22T04:41:14ZengSAGE PublishingClinical and Applied Thrombosis/Hemostasis1938-27232022-12-012810.1177/10760296221132556Rivaroxaban Versus Enoxaparin for Thromboprophylaxis After major Gynecological Cancer Surgery: The VALERIA TrialAndré Luiz Malavasi Longo de Oliveira MD, MSc0Renata Fernanda de Oliveira Pereira MD1Leandro Barile Agati Ph.D2Camilla Moreira Ribeiro Ph.D3Gabrielly Yukimi Kawamura Suguiura4Claudia Helena Cioni MD5Marilsa Bermudez MD6Márcia Bermudez Pirani MD7Roberto Augusto Caffaro MD, Ph.D8Valter Castelli9Valéria Cristina Resende Aguiar MD10Giuliano Giova Volpiani MD11Adilson Paschoa MD, Ph.D12Ariane Vieira Scarlatelli Macedo MD13Pedro Gabriel Melo de Barros e Silva MD, Ph.D14João Carlos de Campos Guerra MD, Ph.D15Jawed Fareed Ph.D16Renato Delascio Lopes MD, Ph.D17Eduardo Ramacciotti MD, Ph.D18 São Paulo State Public Women's Health Reference Center, São Paulo, Brazil São Paulo State Public Women's Health Reference Center, São Paulo, Brazil , Santo André, São Paulo, Brazil , Santo André, São Paulo, Brazil , Santo André, São Paulo, Brazil São Paulo State Public Women's Health Reference Center, São Paulo, Brazil São Paulo State Public Women's Health Reference Center, São Paulo, Brazil São Paulo State Public Women's Health Reference Center, São Paulo, Brazil Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil Hospital e Maternidade Christóvão da Gama, Grupo DASA, Santo André, SP, Brazil Hospital e Maternidade Christóvão da Gama, Grupo DASA, Santo André, SP, Brazil , Brazil Brazilian Clinical Research Institute, São Paulo, São Paulo, Brazil Brazilian Clinical Research Institute, São Paulo, São Paulo, Brazil Hematology and coagulation Laboratory, , São Paulo, Brazil Hemostasis & Thrombosis Research Laboratories at Loyola University Medical Center, Maywood, IL, USA Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA Hemostasis & Thrombosis Research Laboratories at Loyola University Medical Center, Maywood, IL, USADirect 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.https://doi.org/10.1177/10760296221132556 |
| spellingShingle | 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 Rivaroxaban Versus Enoxaparin for Thromboprophylaxis After major Gynecological Cancer Surgery: The VALERIA Trial Clinical and Applied Thrombosis/Hemostasis |
| title | Rivaroxaban Versus Enoxaparin for Thromboprophylaxis After major Gynecological Cancer Surgery: The VALERIA Trial |
| title_full | Rivaroxaban Versus Enoxaparin for Thromboprophylaxis After major Gynecological Cancer Surgery: The VALERIA Trial |
| title_fullStr | Rivaroxaban Versus Enoxaparin for Thromboprophylaxis After major Gynecological Cancer Surgery: The VALERIA Trial |
| title_full_unstemmed | Rivaroxaban Versus Enoxaparin for Thromboprophylaxis After major Gynecological Cancer Surgery: The VALERIA Trial |
| title_short | Rivaroxaban Versus Enoxaparin for Thromboprophylaxis After major Gynecological Cancer Surgery: The VALERIA Trial |
| title_sort | rivaroxaban versus enoxaparin for thromboprophylaxis after major gynecological cancer surgery the valeria trial |
| url | https://doi.org/10.1177/10760296221132556 |
| work_keys_str_mv | AT andreluizmalavasilongodeoliveiramdmsc rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT renatafernandadeoliveirapereiramd rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT leandrobarileagatiphd rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT camillamoreiraribeirophd rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT gabriellyyukimikawamurasuguiura rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT claudiahelenacionimd rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT marilsabermudezmd rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT marciabermudezpiranimd rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT robertoaugustocaffaromdphd rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT valtercastelli rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT valeriacristinaresendeaguiarmd rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT giulianogiovavolpianimd rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT adilsonpaschoamdphd rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT arianevieirascarlatellimacedomd rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT pedrogabrielmelodebarrosesilvamdphd rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT joaocarlosdecamposguerramdphd rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT jawedfareedphd rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT renatodelasciolopesmdphd rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial AT eduardoramacciottimdphd rivaroxabanversusenoxaparinforthromboprophylaxisaftermajorgynecologicalcancersurgerythevaleriatrial |