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)
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The outcomes of patients developing major bleeding on oral anticoagulants remain largely unquantified. Objectives are to: 1) describe the burden of major haemorrhage associated with all available oral anticoagulants in terms of: proportion of bleeds which are intracranial-haemorrhages, in-hospital mortality and duration of hospitalisation following major bleeding; 2) identify risk factors for mortality; 3) compare characteristics of major haemorrhage between warfarin and direct-oral anticoagulants for the subgroup of atrial fibrillation and venous-thromboembolism patients. A multi-centre, three-year prospective cohort study of patients aged ≥18 on oral anticoagulants who developed major haemorrhage leading to hospitalisation. Follow-up was for 30 days or until discharge or death, whichever occurred first. In total 2,192 patients (47% female, 81% warfarin, median age 80 years) were reported between October 2013 and August 2016 from 32 UK hospitals. Bleed sites were: intracranial-haemorrhage (44%); gastrointestinal (33%); and other (24%). The in-hospital mortality was 21% (95%CI: 19%-23%) overall, and 33% (95%CI: 30%-36%) for intracranial haemorrhage patients. Intracranial-haemorrhage, advanced age, spontaneous bleeding, liver failure and cancer were risk factors for death. Compared to warfarin, direct-oral anticoagulant patients were comparatively older and were associated with lower odds of subdural/epidural, subarachnoid and intracerebral bleeding, versus lower gastrointestinal bleeding. Mortality of major bleeding on warfarin and direct-oral anticoagulants were not different. Major bleeding on oral anticoagulants leads to considerable hospital stays and short-term mortality. Direct-oral anticoagulants were associated with lower odds of an intracranial haemorrhage versus gastrointestinal bleeding, compared to warfarin. The case-fatalities of major bleeding on warfarin and direct- oral anticoagulants were similar.