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Prediction of which patients with venous thromboembolism may benefit from an extended anticoagulation 3 months post diagnosis
Safe People
Organisation name
Bristol-Myers Squibb Pharmaceuticals Ltd (BMS)
Organisation sector
Commercial
Applicant name(s)
Kevin Pollock - Chief Investigator - Bristol-Myers Squibb Pharmaceuticals Limited - UK ( BMS )
Carlos Martinez - Corresponding Applicant - Institute for Epidemiology
Statistics and Informatics GmbH (Pharma Epi)
Alexander Cohen - Collaborator - King's College London
Amaia Irizar - Collaborator - Forecom Bioscience Ltd
Christopher Wallenhorst - Collaborator - Institute for Epidemiology
Statistics and Informatics GmbH (Pharma Epi)
Imran Khan - Collaborator - Pfizer Ltd - UK
Mikel Bober - Collaborator - Forecom Bioscience Ltd
Miroslaw Bober - Collaborator - University of Surrey
Satarupa Choudhuri - Collaborator - Not from an Organisation
Stephan Rietbrock - Collaborator - Institute for Epidemiology
Statistics and Informatics GmbH (Pharma Epi)
Susan Miller - Collaborator - Pfizer Ltd - UK
Zbigniew Galias - Collaborator - Forecom Bioscience Ltd
Safe Projects
Project ID
CPRD252
Lay summary
Blood clots often form in the veins of the legs or in the lungs. They are usually treated with “blood thinning” drugs called anticoagulants. Guidelines recommend treatment for 3-6 months for some patients and longer for others. The general recommendation is that all patients receive at least 3 months of anticoagulation. After stopping anticoagulants blood clots are more likely to recur, whilst taking anticoagulants patients are more likely to have bleeding complications. The balance between continuing or stopping anticoagulants is clear for some patients but not for others where the risks and benefits may be more closely balanced. Our aim is to be able to predict more accurately the risks and benefits of stopping anticoagulation after 3-6 months or continuing anticoagulation for a longer period of time.
Technical summary
Venous thromboembolism (VTE) which consists of deep vein thrombosis (DVT) and pulmonary embolism (PE) is a common cause of morbidity and mortality. Many guidelines divide the anticoagulation (AC) therapy of VTE into various phases of treatment following the initial diagnosis, the acute phase for the first 1-2 weeks, the long-term treatment phase for 3-6 months, and the extended phase after the first 3-6months. Treatment duration is mainly based upon the risk of recurrence of VTE (R-VTE). The recommendation is that patients receive at least 3 months of anticoagulation. Patients at high risk of recurrence are offered extended anticoagulation. The risk of bleeding, unless very high, is not usually a major part of that calculation. Bleeding risks are considered separately and are loosely based on accumulating risks from data derived in both VTE and atrial fibrillation patients. Currently, insufficient data exist to support the integration of bleeding risk into duration of therapy planning and a combination of clinical insight, patient prothrombotic factors and patient choice informs anticoagulation duration.
Latest approval date
22/04/2021
Safe Data
Dataset(s) name
HES Admitted Patient Care
HES Diagnostic Imaging Dataset
HES Outpatient
ONS Death Registration Data
Patient Level Index of Multiple Deprivation
Safe Setting
Access type
Release