Page 194 - Haematologica-April 2018

Coagulation & its Disorders
A three-year prospective study of the presentation and clinical outcomes of major bleeding episodes associated with oral anticoagulant use in the UK (ORANGE study)
Laura Green,*1,2,3 Joachim Tan,*1 Joan K Morris,1 Raza Alikhan,4 Nicola Curry,5,6 Tamara Everington,7,8 Rhona Maclean,9 Khalid Saja,10 Simon Stanworth,5,6,11 Campbell Tait12 and Peter MacCallum1,2
Barts and the London School of Medicine and Dentistry, Queen Mary University of London; 2Barts Health NHS Trust, London; 3NHS Blood and Transplant, Colindale; 4University Hospital of Wales, Cardiff and Vale University Health Board; 5Department of Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford 6Radcliffe Department of Medicine, University of Oxford, and Oxford BRC Haematology Theme; 7Hampshire Hospitals NHS Foundation Trust; 8Salisbury NHS Foundation Trust; 9Sheffield Teaching Hospitals NHS Foundation Trust; 10Barking, Havering and Redbridge University Hospitals NHS Trust; 11Transfusion Medicine, NHS Blood and Transplant, Oxford and 12Glasgow Royal Infirmary, NHS Greater Glasgow and Clyde, UK
ABSTRACT
The outcomes of patients developing major bleeding while on oral anticoagulants remain largely unquantified. The objectives of this study were to: (i) describe the burden of major hemorrhage asso- ciated with all available oral anticoagulants in terms of proportion of bleeds which are intracranial hemorrhages, in-hospital mortality and duration of hospitalization following major bleeding; (ii) identify risk factors for mortality; and (iii) compare the characteristics of major hem- orrhage between cases treated with warfarin and direct oral anticoagu- lants for the subgroups of patients with atrial fibrillation or venous thromboembolism. This was a multicenter, 3-year prospective cohort study of patients aged ≥18 years on oral anticoagulants who developed major hemorrhage leading to hospitalization. The patients were fol- lowed up for 30 days or until discharge or death, whichever occurred first. In total 2,192 patients (47% female, 81% on warfarin, median age 80 years) were reported between October 2013 and August 2016 from 32 hospitals in the UK. Bleeding sites were intracranial (44%), gastroin- testinal (33%), and other (24%). The in-hospital mortality was 21% (95% CI: 19%-23%) overall, and 33% (95% CI: 30%-36%) for patients with intracranial hemorrhage. Intracranial hemorrhage, advanced age, spontaneous bleeding, liver failure and cancer were risk factors for death. Compared to warfarin-treated patients, patients treated with direct oral anticoagulants were older and had lower odds of subdural/epidural, sub- arachnoid and intracerebral bleeding. The mortality rate due to major bleeding was not different between patients being treated with warfarin or direct oral anticoagulants. Major bleeding while on oral anticoagulant therapy leads to considerable hospital stays and short-term mortality.
Introduction
Oral anticoagulants (OAC) are highly effective for stroke prevention in patients with atrial fibrillation,1,2 for the treatment and prevention of venous thromboem- bolism,3 and for the prevention of thrombosis related to mechanical heart valves.4,5 It is estimated that OAC therapy is required for 1.25 million people per year in the UK with approximately 70% being for those with atrial fibrillation.6 This require- ment is likely to continue to rise in an aging population, given that the prevalence
Correspondence:
laura.green@bartshealth.nhs.uk
Received: October 6, 2017. Accepted: January 22, 2018. Pre-published: January 25, 2018.
doi:10.3324/haematol.2017.182220
Check the online version for the most updated information on this article, online supplements, and information on authorship & disclosures: www.haematologica.org/content/103/4/x738
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Haematologica 2018 Volume 103(4):738-745
Ferrata Storti Foundation
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*Joint first authors
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