Abstract
BackgroundVenous 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/designThe 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.ResultsOverall, 381 centers participated, which enrolled 3,545 patients during an observational period of 1 year.ConclusionThe 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 registrationRegistered in DRKS register, ID number: DRKS00004795
Highlights
Venous thromboembolism (VTE) is a major health problem, with over one million events every year in Europe
According to current practice guidelines the management of patients with acute VTE consists of an initial treatment with bodyweightadjusted subcutaneous low molecular weight heparin (LMWH); adjusted-dose intravenous or fixed dose subcutaneous unfractionated heparin (UFH); or bodyweightadjusted subcutaneous fondaparinux followed by longterm treatment with a vitamin K antagonist (VKA) or non-VKA oral anticoagulants (NOACs) [5]
For the treatment of pulmonary embolism (PE) the current 2014 European Society of Cardiology Guidelines on the diagnosis and management of acute PE recommend the use of NOACs as alternatives to VKAs [6]
Summary
Venous thromboembolism (VTE) is a major health problem, with over one million events every year in Europe. For most patients with a DVT and/or PE secondary to a transient risk factor the currently recommended duration of treatment is sufficient, extension by another 3 to 6 months of therapy may be indicated in some patients [3]. For those with unprovoked DVT or PE, the recommendation is to evaluate the risks and benefits for prolonged therapy. The VKA dosage regimen needs to be adjusted to maintain the INR in the therapeutic range (target 2.5, range 2.0 to 3.0)
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