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. Issue 11 (3rd November 2020)

• Record Type: Journal Article
• Authors: Evans, Alison; Davies, Miranda; Osborne, Vicki; Roy, Debabrata; Shakir, Saad
• Is Part Of: BMJ open. Volume 10:Issue 11(2020)
• Publication Date: 2020-11-03
• Subjects: thromboembolism -- anticoagulation -- risk management; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-038102
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Objectives: To 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. Design: An observational cohort study using the technique of Specialist Cohort Event Monitoring. Setting: The Rivaroxaban Observational Safety Evaluation study was conducted across 87 participating National Health Service secondary care trusts in England and Wales. Participants: 1532 patients treated with rivaroxaban for the prevention and treatment of deep vein thrombosis/pulmonary embolism from September 2013 to January 2016. Interventions: Non-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. Results: Of 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. Conclusions: In 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 numbers: ClinicalTrials.gov Registry (NCT01871194 ); ENCePP Registry (EUPAS3979).