Hospital admissions for bleeding events associated with treatment with apixaban, dabigatran and rivaroxaban

• Published in: European journal of hospital pharmacy : science and practice Vol. 26; no. 2; pp. 106 - 112
• Main Authors: Marco Garbayo, José Luis, Koninckx Cañada, Manuel, Pérez Castelló, Isabel, Faus Soler, María Teresa, Perea Ribis, Mariam
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.03.2019; BMJ Publishing Group
• Subjects: Anemia; Anticoagulants; Cardiac arrhythmia; Computerized physician order entry; Consortia; Disease prevention; Drug therapy; Family medical history; Heart; Hospitals; Mortality; Original; Patient safety; Population; Stroke; Thrombosis; Borja Spain; Spain; direct oral anticoagulants; atrial fibrillation; bleeding; non–vitamin K antagonist oral anticoagulants; safety; intracranial haemorrhage; pharmacovigilance; gastrointestinal haemorrhage; hospitalisation
• ISSN: 2047-9956; 2047-9964
• DOI: 10.1136/ejhpharm-2017-001390

ObjectivesTo analyse the hospital admissions for bleeding events associated with treatment with direct oral anticoagulants (DOACs). To describe the characteristics and outcomes of those patients.MethodsA retrospective observational study was carried out in the framework of an integral risk management plan of drugs and proactive pharmacovigilance of hospital admissions for bleeding associated with apixaban, dabigatran and rivaroxaban from April 2015 through December 2016. Cases were identified using the information management tool of Orion Clinic (hospital electronic medical history) and by reviewing the hospital discharge reports. Various biometric, clinical and pharmacotherapeutic variables of each patient were registered.Results37 hospitalisation episodes for DOAC-induced bleeding in 32 patients (15 received rivaroxaban, 9 apixaban and 8 dabigatran) were detected, representing an incidence rate of 3.44 per 100 person-years (95% CI 2.35 to 4.86). The most common bleeding site was gastrointestinal (27 cases, 73.0%). Intracranial bleeding was rare (three cases, 8.1%). Four patients (12.5%) were receiving DOACs at full doses and had a ’dose reduction indication'. The mean (SD) length of stay was 8.4 (5.2) days. Three patients (8.1%) died during the hospitalisation. Among bleeding episodes without fatal outcome, DOACs were stopped in 14 cases, continued in 14 cases, switched for another DOAC in two cases and the dose was reduced in four cases.ConclusionsDOACs are associated with serious bleeding events that require hospitalisation. The risk/benefit ratio assessment considering patient preferences and an individualised follow-up, especially in patients who are elderly, polymedicated or have impaired renal function, can help to reinforce the safe use of DOACs.