Rivaroxaban Versus Enoxaparin for Thromboprophylaxis After major Gynecological Cancer Surgery: The VALERIA Trial : Venous thromboembolism prophylAxis after gynecoLogical pElvic cancer surgery with RIvaroxaban versus enoxAparin (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 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.

Comparison of different laboratory tests in the evaluation of hemorrhagic risk of patients using rivaroxaban in the critical care setting: diagnostic accuracy study.

BACKGROUND: Rivaroxaban is a direct oral anticoagulant designed to dispense with the necessity of laboratory monitoring. However, monitoring rivaroxaban levels is necessary in certain clinical conditions, especially in the critical care setting. METHODS: This is a diagnostic accuracy study evaluating sensitivity and specificity of prothrombin time (PT), activated partial thromboplastin time (aPTT), and Dilute Russell viper venom time (dRVVT), to evaluate the hemorrhagic risk in patients taking rivaroxaban. The study used a convenience sample of 40 clinically stable patients using rivaroxaban to treat deep vein thrombosis or atrial fibrillation admitted in a private hospital in Brazil, compared to a group of 60 healthy controls. The samples from patients were collected two hours after the use of the medication (peak) and two hours before the next dose (trough). RESULTS: The correlation with the plasmatic concentration measured by anti-FXa assay was higher for PT and dRVVTS. The PT and aPTT tests presented higher specificity, while dRVVT was 100% sensible. CONCLUSIONS: There was a strong correlation between the tests and the plasma concentration of the drug. Additionally, our results demonstrated the potential use of dRVVT as a screening test in the emergency room and the need of a second test to improve specificity.

Rediscussing Anticoagulation in Distal Deep Venous Thrombosis.

BACKGROUND: Distal deep venous thrombosis (DVT) accounts for approximately half of all the cases of lower limb thrombosis. The impact and management of this condition is still controversial. This study aims to evaluate the incidence of pulmonary embolism (PE) in patients with distal DVT in comparison to proximal DVT and evaluate the correlation between DVT and PE extension. METHODS: 100 patients with acute lower limb DVT diagnosed with whole leg Doppler ultrasound from January 2006 to December 2014 were retrospectively analyzed. Active investigation for PE was carried out in all patients using multislice computed tomography angiography. Classification of DVT and PE was based on the proximal extension of the thrombus. RESULTS: The overall incidence of PE in our sample patients was 72%. In the subgroup analysis, incidence of PE was equal in both the proximal and distal DVT groups (77%, p > 0.99). PE was detected in 43% of the patients with isolated calf vein thrombosis (ICVT). No statistical difference was observed between the distribution of lobar, segmental and subsegmental PE in the 3 DVT subgroups (p = 0.665); however, truncular PE was only observed in the proximal DVT group. CONCLUSION: Distal DVT is associated with a high incidence of PE compared to proximal DVT. Distal DVT and ICVT can provoke PE with involvement of proximal vessels in the pulmonary arterial tree, even in asymptomatic patients. Our study arises discussion in the controversial debate regarding the need for routine anticoagulation in distal DVT.

Highlights from the fifth international symposium of thrombosis and anticoagulation (ISTA V), October 18-19, 2012, Belo Horizonte, Minas Gerais, Brazil.

To discuss and share knowledge about advances in the care of patients with thrombotic disorders, the Fifth International Symposium of Thrombosis and Anticoagulation was held in Belo Horizonte, Minas Gerais, Brazil, on October 18-19, 2012. This scientific program was developed by clinicians for clinicians and was promoted by three major clinical research institutes: the Brazilian Clinical Research Institute, the Duke Clinical Research Institute of the Duke University School of Medicine, and Hospital do Coração Research Institute. Comprising 2 days of academic presentations and open discussion, the symposium had as its primary goal to educate, motivate, and inspire internists, cardiologists, hematologists, and other physicians by convening national and international visionaries, thought-leaders, and dedicated clinician-scientists. This paper summarizes the symposium proceedings.

Risk of asymptomatic pulmonary embolism in patients with deep venous thrombosis.

OBJECTIVE: The aim of our study is to evaluate the incidence of asymptomatic pulmonary embolism (PE) in patients with deep venous thrombosis (DVT), submitted to routine angiography of pulmonary vessels, and analyze the relationship between the site of DVT and extent of PE. METHODS: Between January 2006 and April 2012, 52 consecutive patients with acute inferior limb DVT were divided into two study groups composed of individuals with proximal and distal thrombotic involvement. All patients had no respiratory symptoms and were submitted to routine pulmonary computed tomography angiography for active investigation of PE. We assessed the incidence and extent of PE in both study groups. RESULTS: Thirty-eight patients (72%) had PE, detected by computed tomography angiography. The incidence of PE in patients with proximal and distal thrombosis, respectively, was 72.7% and 73.7%. Occurrence of segmental embolism was equally high in both groups, affecting 71.4% of the patients with distal thrombosis and 66.6% of the individuals with proximal DVT (P > .99). CONCLUSIONS: The incidence of asymptomatic PE observed in patients with DVT is higher than what is reported in the current literature. This supports the importance of screening and the need for high levels of suspicion regarding this complication.