Evidence map›Paper›PMID 36474344›Full record

Trial reportClinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis

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

André Luiz Malavasi Longo de Oliveira, Renata Fernanda de Oliveira Pereira, Leandro Barile Agati, Camilla Moreira Ribeiro, Gabrielly Yukimi Kawamura Suguiura, Claudia Helena Cioni, Marilsa Bermudez, Márcia Bermudez Pirani, Roberto Augusto Caffaro, Valter Castelli and 9 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 5 pooled it
5.6field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 5 syntheses or guidelines pooled it, 28 citations in OpenAlex.

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  5. Efficacy and Safety of Rivaroxaban Versus Enoxaparin in Prevention of Recurrence of Venous Thrombo-Embolism Events in Cancer Patients: A Meta-Analysis.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 5 institutions in 2 countries.

André Luiz Malavasi Longo de OliveiraSão Paulo State Public Women's Health Reference Center, São Paulo, Brazil.
Renata Fernanda de Oliveira PereiraSão Paulo State Public Women's Health Reference Center, São Paulo, Brazil.
Leandro Barile Agati600818Science Valley Research Institute, Santo André, São Paulo, Brazil.
Camilla Moreira Ribeiro600818Science Valley Research Institute, Santo André, São Paulo, Brazil.
Gabrielly Yukimi Kawamura Suguiura600818Science Valley Research Institute, Santo André, São Paulo, Brazil.
Claudia Helena CioniSão Paulo State Public Women's Health Reference Center, São Paulo, Brazil.
Marilsa BermudezSão Paulo State Public Women's Health Reference Center, São Paulo, Brazil.
Márcia Bermudez PiraniSão Paulo State Public Women's Health Reference Center, São Paulo, Brazil.
Roberto Augusto CaffaroSanta Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.
Valter CastelliSanta Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.
Valéria Cristina Resende AguiarHospital e Maternidade Christóvão da Gama, Grupo DASA, Santo André, SP, Brazil.
Giuliano Giova VolpianiSanta Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.
Adilson Paschoa155099Beneficência Portuguesa de São Paulo, Brazil.
Ariane Vieira Scarlatelli MacedoBrazilian Clinical Research Institute, São Paulo, São Paulo, Brazil.ORCID 0000-0002-3453-8488
Pedro Gabriel Melo de Barros E SilvaBrazilian Clinical Research Institute, São Paulo, São Paulo, Brazil.ORCID 0000-0003-1940-4470
João Carlos de Campos GuerraHematology and coagulation Laboratory, 37896Hospital Israelita Albert Einstein, São Paulo, Brazil.
Jawed FareedHemostasis & Thrombosis Research Laboratories at Loyola University Medical Center, Maywood, IL, USA.ORCID 0000-0003-3465-2499
Renato Delascio LopesDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Eduardo Ramacciotti600818Science Valley Research Institute, Santo André, São Paulo, Brazil.ORCID 0000-0002-5735-1333
Faculdade de Ciências Médicas da Santa Casa de São Paulo · BRLoyola University Medical Center · USBeneficência Portuguesa de São Paulo · BRDuke University · USHospital Israelita Albert Einstein · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Pelvic NeoplasmsVenous ThromboembolismAnticoagulantsEnoxaparinHeparin, Low-Molecular-WeightHumansRivaroxabanAnticoagulantsEnoxaparinHeparin, Low-Molecular-WeightRivaroxabancancerenoxaparingynecology and obstetricsrivaroxabanvenous thromboembolism

Identifiers

PMID36474344
PMCPMC9732794
OpenAlexW4311586201

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.