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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 EpidemiologyStatistics and Informatics GmbH (Pharma Epi)Alexander Cohen - Collaborator - King's College LondonAmaia Irizar - Collaborator - Forecom Bioscience LtdChristopher Wallenhorst - Collaborator - Institute for EpidemiologyStatistics and Informatics GmbH (Pharma Epi)Imran Khan - Collaborator - Pfizer Ltd - UKMikel Bober - Collaborator - Forecom Bioscience LtdMiroslaw Bober - Collaborator - University of SurreySatarupa Choudhuri - Collaborator - Not from an OrganisationStephan Rietbrock - Collaborator - Institute for EpidemiologyStatistics and Informatics GmbH (Pharma Epi)Susan Miller - Collaborator - Pfizer Ltd - UKZbigniew 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