The management of acute venous thromboembolism in clinical practice. Results from the European PREFER in VTE Registry

Venous thromboembolism (VTE) is a significant cause of morbidity and mortality in Europe. Data from real-world registries are necessary, as clinical trials do not represent the full spectrum of VTE patients seen in clinical practice. We aimed to document the epidemiology, management and outcomes of VTE using data from a large, observational database. PREFER in VTE was an international, non-interventional disease registry conducted between January 2013 and July 2015 in primary and secondary care across seven European countries. Consecutive patients with acute VTE were documented and followed up over 12 months. PREFER in VTE included 3,455 patients with a mean age of 60.8 ± 17.0 years. Overall, 53.0 % were male. The majority of patients were assessed in the hospital setting as inpatients or outpatients (78.5 %). The diagnosis was deep-vein thrombosis (DVT) in 59.5 % and pulmonary embolism (PE) in 40.5 %. The most common comorbidities were the various types of cardiovascular disease (excluding hypertension; 45.5 %), hypertension (42.3 %) and dyslipidaemia (21.1 %). Following the index VTE, a large proportion of patients received initial therapy with heparin (73.2 %), almost half received a vitamin K antagonist (48.7 %) and nearly a quarter received a DOAC (24.5 %). Almost a quarter of all presentations were for recurrent VTE, with >80 % of previous episodes having occurred more than 12 months prior to baseline. In conclusion, PREFER in VTE has provided contemporary insights into VTE patients and their real-world management, including their baseline characteristics, risk factors, disease history, symptoms and signs, initial therapy and outcomes

The FuGas 2.3 Framework for Atmosphere–Ocean Coupling: Comparing Algorithms for the Estimation of Solubilities and Gas Fluxes

Accurate estimates of the atmosphere–ocean fluxes of greenhouse gases and dimethyl sulphide (DMS) have great importance in climate change models. A significant part of these fluxes occur at the coastal ocean which, although much smaller than the open ocean, have more heterogeneous conditions. Hence, Earth System Modelling (ESM) requires representing the oceans at finer resolutions which, in turn, requires better descriptions of the chemical, physical and biological processes. The standard formulations for the solubilities and gas transfer velocities across air–water surfaces are 36 and 24 years old, and new alternatives have emerged. We have developed a framework combining the related geophysical processes and choosing from alternative formulations with different degrees of complexity. The framework was tested with fine resolution data from the European coastal ocean. Although the benchmark and alternative solubility formulations generally agreed well, their minor divergences yielded differences of up to 5.8% for CH4 dissolved at the ocean surface. The transfer velocities differ strongly (often more than 100%), a consequence of the benchmark empirical wind-based formulation disregarding significant factors that were included in the alternatives. We conclude that ESM requires more comprehensive simulations of atmosphere–ocean interactions, and that further calibration and validation is needed for the formulations to be able to reproduce it. We propose this framework as a basis to update with formulations for processes specific to the air–water boundary, such as the presence of surfactants, rain, the hydration reaction or biological activity

Incidence and predictors of venous thromboembolism recurrence after a first isolated distal deep vein thrombosis

International audienceBACKGROUND:Isolated distal deep vein thrombosis (iDDVT) (i.e. without proximal DVT or pulmonary embolism) represents half of all cases of lower limb DVT. Its clinical significance and management are controversial. Data on long-term follow-up are scarce, especially concerning risk and predictors of venous thromboembolism (VTE) recurrence.METHODS:Using data from the OPTIMEV (OPTimisation de l'Interrogatoire dans l'évaluation du risque throMbo-Embolique Veineux) study, a prospective, observational, multicenter study, we compared, 3 years after an index VTE event and after discontinuation of anticoagulants, (i) the incidence and type of recurrence in patients without cancer with a first iDDVT vs. a first isolated proximal DVT (iPDVT) and (ii) predictors of recurrence after iDDVT.RESULTS:Compared with patients with iPDVT (n = 259), patients with an iDDVT (n = 490) had a lower annualized incidence of overall VTE recurrence (5.2% [95% confidence interval 3.6-7.6] vs. 2.7% [1.9-3.8], respectively; P = 0.02) but a similar incidence of pulmonary embolism recurrence (1.0% [0.5-2.3] vs. 0.9% [0.5-1.6], respectively; P = 0.83). An age of > 50 years, unprovoked character of index iDDVT, and involvement of more than one vein in one or both legs each independently tripled the risk of recurrence, with the latter then being ≥ 3% per patient-year. Neither muscular vein nor deep-calf vein location of iDDVT nor clot diameter with compression influenced the risk of recurrence.CONCLUSIONS:After stopping anticoagulants, patients with iDDVT have a significantly lower risk of overall VTE recurrence than did patients with iPDVT but a similar risk of serious recurrent VTE. Age > 50 years, unprovoked iDDVT, and number of thrombosed veins (more than one) influenced the risk of recurrence and may help to define patients at significant risk of recurrence

Anticoagulant therapy for symptomatic calf deep vein thrombosis (CACTUS): a randomised, double-blind, placebo-controlled trial.

The efficacy and safety of anticoagulant treatment is not established for patients with acute symptomatic deep vein thrombosis (DVT) of the calf. We aimed to assess whether therapeutic anticoagulation is superior to placebo in patients with symptomatic calf DVT. In this randomised, double-blind, placebo-controlled trial, we enrolled low-risk outpatients (without active cancer or previous venous thromboembolic disease) with a first acute symptomatic DVT in the calf from 23 university medical centres or community medical clinics in Canada, France, and Switzerland. We randomly assigned (1:1) patients to receive either the low-molecular-weight heparin nadroparin (171 UI/kg, subcutaneously, once a day) or placebo (saline 0·9%, subcutaneously, once a day) for 6 weeks (42 days). Central randomisation was done using a computer-generated randomisation list, stratified by study centre. Random allocation sequences of variable block size were centrally determined by an independent research clinical centre. Study staff, patients, and outcome assessors (central adjudication committee) were masked to group assignment. Numbered boxes of active drug or placebo were provided to pharmacies in identical packaging. All patients were prescribed compression stockings and followed up for 90 days. The primary efficacy outcome was a composite measure of extension of calf DVT to proximal veins, contralateral proximal DVT, and symptomatic pulmonary embolism at day 42 in the modified intention-to-treat population. The primary safety outcome was major or clinically relevant non-major bleeding at day 42. The trial was registered with ClinicalTrials.gov, number NCT00421538. Between Feb 1, 2008, and Nov 30, 2014, we screened 746 patients, enrolling 259 patients (50% of the prespecified sample size), before the trial steering committee terminated the trial because of expiry of study drug and slow recruitment. The intention-to-treat analysis population comprised 122 patients in the nadroparin group and 130 in the placebo group. There was no significant difference between the groups in the composite primary outcome, which occurred in four patients (3%) in the nadroparin group and in seven (5%) in the placebo group (risk difference -2·1%, 95% CI -7·8 to 3·5; p=0·54). Bleeding occurred in five patients (4%) in the nadroparin group and no patients in the placebo group (risk difference 4·1, 95% CI 0·4 to 9·2; p=0·0255). In the nadroparin group one patient died from metastatic pancreatic cancer and one patient was diagnosed with heparin-induced thrombocytopenia type 2. Nadroparin was not superior to placebo in reducing the risk of proximal extension or venous thromboembolic events in low-risk outpatients with symptomatic calf DVT, but did increase the risk of bleeding. Avoidance of systematic anticoagulation for calf DVT could have a substantial impact on individual patients and from a public health perspective. Swiss National Science Foundation, the Programme Hospitalier de Recherche Clinique in France, and the Canadian Institutes of Health Research

Questions non résolues sur la maladie thrombo-embolique veineuse. Consensus de la Société française de médecine vasculaire (SFMV)

International audienceNo abstract availabl

Proposal of the French Society of Vascular Medicine for the prevention, diagnosis and treatment of venous thromboembolic disease in outpatients with COVID-19

International audienceThe proposal is intended to help physicians treating patients with COVID-19 for the diagnosis, treatment and prevention of venous thromboembolic disease either when leaving the hospital or treated as outpatients.This document is a synthesis of opinions of a working group from the French Society of Vascular Medicine (SFMV) composed of private practice and hospital-based physicians. This proposal is based on a limited level of evidence. This proposal is likely to evolve with the knowledge of the disease

The management of acute venous thromboembolism in clinical practice - study rationale and protocol of the European PREFER in VTE Registry

Background: Venous thromboembolism (VTE) is a major health problem, with over one million events every year in Europe. However, there is a paucity of data on the current management in real life, including factors influencing treatment pathways, patient satisfaction, quality of life (QoL), and utilization of health care resources and the corresponding costs. The PREFER in VTE registry has been designed to address this and to understand medical care and needs as well as potential gaps for improvement. Methods/design: The PREFER in VTE registry was a prospective, observational, multicenter study conducted in seven European countries including Austria, France Germany, Italy, Spain, Switzerland, and the UK to assess the characteristics and the management of patients with VTE, the use of health care resources, and to provide data to estimate the costs for 12 months treatment following a first-time and/or recurrent VTE diagnosed in hospitals or specialized or primary care centers. In addition, existing anticoagulant treatment patterns, patient pathways, clinical outcomes, treatment satisfaction, and health related QoL were documented. The centers were chosen to reflect the care environment in which patients with VTE are managed in each of the participating countries. Patients were eligible to be enrolled into the registry if they were at least 18 years old, had a symptomatic, objectively confirmed first time or recurrent acute VTE defined as either distal or proximal deep vein thrombosis, pulmonary embolism or both. After the baseline visit at the time of the acute VTE event, further follow-up documentations occurred at 1, 3, 6 and 12 months. Follow-up data was collected by either routinely scheduled visits or by telephone calls. Results: Overall, 381 centers participated, which enrolled 3,545 patients during an observational period of 1 year. Conclusion: The PREFER in VTE registry will provide valuable insights into the characteristics of patients with VTE and their acute and mid-term management, as well as into drug utilization and the use of health care resources in acute first-time and/or recurrent VTE across Europe in clinical practice. Trial registration: Registered in DRKS register, ID number: DRKS0000479

The management of patients with venous thromboembolism in Italy: insights from the PREFER in VTE registry

Venous thromboembolism (VTE) is the third most common cardiovascular disease. Real-life data on the clinical presentation, risk factors, diagnosis, and treatment of VTE in Italy and Europe are required to optimize the management of this disease. The PREFER in VTE registry, a prospective non-interventional real-life study, was designed to assess clinical characteristics and management of patients with VTE, use of health care resources, and on-treatment patient quality of life. Eligible consecutive patients with objectively diagnosed VTE were enrolled in the registry and followed up for 12 months. Between January and December 2013, 816 Italian and 1027 patients from 6 European countries other than Italy (European patients) were enrolled in the registry, and followed up until December 2014. Italian patients were the oldest (mean age 65.7 years) among the European patients. The Italian patients with a history of cancer were 24.6 % of whom 63.2 % had an active cancer (18.2 and 57.0 %, respectively, in Europe). Parenteral heparin was given, as initial treatment, in 73.8 % of Italian patients (66.4 % in Europe); VKA in combination with other treatments in 45.8 % (34.7 % in Europe); and VKA as the only anticoagulant treatment in 24.4 % (17.2 % in Europe). Of the Italian patients, 43.2 and 90.6 % of patients were hospitalized for deep vein thrombosis and pulmonary embolism, respectively; 65.4 % were admitted to the hospital through the emergency department. Following a real world approach, PREFER in VTE shows that the Italian patients, among and compared to the European patients, are the oldest, have a history of cancer more commonly, receive an initial treatment with heparin more commonly, and are more commonly hospitalized, particularly if affected by PE