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
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.


CONCLUSIONS
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.


BACKGROUND
Registered in DRKS register, ID number: DRKS00004795.
University of Perugia, Santa Maria della Misericordia Hospital, Perugia, Italy.
Giancarlo
G
Agnelli
Herzzentrum Ludwigshafen Med. Klinik B, Ludwigshafen, Germany.
Anselm K
AK
Gitt
Klinikum Darmstadt GmbH, Darmstadt, Center of Thrombosis and Hemostasis, University of Mainz, Mainz, Germany ; Center of Thrombosis and Haemostasis, University of Mainz, Mainz, Germany.
Rupert
R
Bauersachs
Daiichi Sankyo Europe GmbH, Munich, Germany.
Eva-Maria
EM
Fronk
Daiichi Sankyo Europe GmbH, Munich, Germany.
Petra
P
Laeis
CHU Saint-Etienne Hopital Nord, Saint Etienne, Cedex 2 France.
Patrick
P
Mismetti
Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.
Manuel
M
Monreal
Charité - Universitätsmedizin Berlin, Berlin, Germany.
Stefan N
SN
Willich
Center of Thrombosis and Haemostasis, University of Mainz, Mainz, Germany.
Wolf-Peter
WP
Wolf
King's College, Guys and St Thomas' Hospitals NHS Foundation Trust, Westminster Bridge Road, London, SE1 7EH UK.
Alexander T
AT
Cohen
Anticoagulation; Novel Oral Anticoagulants; Prevention; Registry; Venous Thromboembolism; Vitamin K antagonists