Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort study

ObjectivesTo evaluate the short-term (12 weeks) safety and utilisation of rivaroxaban prescribed to new-user adult patients for the treatment of deep vein thrombosis and pulmonary embolism and for the prevention of recurrent deep vein thrombosis and pulmonary embolism in a secondary care setting in...

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Bibliographic Details
Published in:BMJ open Vol. 10; no. 11; p. e038102
Main Authors: Evans, Alison, Davies, Miranda, Osborne, Vicki, Roy, Debabrata, Shakir, Saad
Format: Journal Article
Language:English
Published: England British Medical Journal Publishing Group 03.11.2020
BMJ Publishing Group LTD
BMJ Publishing Group
Series:Original research
Subjects:
Age
Aged
Anticoagulants
Anticoagulants - adverse effects
anticoagulation
Cardiovascular Medicine
Clinical trials
Cohort analysis
Cohort Studies
Drug dosages
England - epidemiology
Family physicians
Female
Humans
Hypertension
Incidence
Male
Middle Aged
Non-pharmacological intervention
Observational studies
Patients
Prevention
Primary care
Pulmonary Embolism - drug therapy
Pulmonary Embolism - epidemiology
Pulmonary Embolism - prevention & control
Pulmonary embolisms
Questionnaires
risk management
Rivaroxaban - adverse effects
Secondary Care
State Medicine
Stroke
Thromboembolism
Thrombosis
United Kingdom - epidemiology
Venous Thromboembolism - drug therapy
Venous Thromboembolism - epidemiology
Venous Thromboembolism - prevention & control
Venous Thrombosis - drug therapy
Venous Thrombosis - epidemiology
Venous Thrombosis - prevention & control
Wales
England
United Kingdom
Wales
United Kingdom > UK
risk management
thromboembolism
anticoagulation
ISSN:2044-6055, 2044-6055
Online Access:Get full text
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Summary:ObjectivesTo evaluate the short-term (12 weeks) safety and utilisation of rivaroxaban prescribed to new-user adult patients for the treatment of deep vein thrombosis and pulmonary embolism and for the prevention of recurrent deep vein thrombosis and pulmonary embolism in a secondary care setting in England and Wales.DesignAn observational cohort study using the technique of Specialist Cohort Event Monitoring.SettingThe Rivaroxaban Observational Safety Evaluation study was conducted across 87 participating National Health Service secondary care trusts in England and Wales.Participants1532 patients treated with rivaroxaban for the prevention and treatment of deep vein thrombosis/pulmonary embolism from September 2013 to January 2016.InterventionsNon-interventional postauthorisation safety study of rivaroxaban.Primary and secondary outcome measures(1) Risk of major bleeding in gastrointestinal, intracranial, and urogenital sites and (2) risk of all major and clinically relevant non-major bleeds.ResultsOf a total of 4846 patients enrolled in the study from September 2013 to January 2016, 1532 were treated with rivaroxaban for the prevention and treatment of deep vein thrombosis/pulmonary embolism. The median age of the deep vein thrombosis/pulmonary embolism cohort was 63 years, and 54.6% were men. The risk of major bleeding within the gastrointestinal, urogenital and intracranial primary sites was 0.7% (n=11), 0.3% (n=5) and 0.1% (n=1), respectively. The risk of major bleeding in all sites was 1.5% (n=23) at a rate of 8.3 events per 100 patient-years.ConclusionsIn terms of the primary outcome risk of major bleeding in gastrointestinal, intracranial and urogenital sites, the risk estimates in the population using rivaroxaban for deep vein thrombosis/pulmonary embolism were low (<1%) and consistent with the risk estimated from clinical trial data and in routine clinical practice.Trial registration numbersClinicalTrials.gov Registry (NCT01871194); ENCePP Registry (EUPAS3979).
Bibliography:Original research
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ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2020-038102