OBJECTIVES: To analyse the hospital admissions for bleeding events associated with treatment with direct oral anticoagulants (DOACs). To describe the characteristics and outcomes of those patients. METHODS: A 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. RESULTS: 37 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. CONCLUSIONS: DOACs 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.
OBJECTIVES: To analyse the hospital admissions for bleeding events associated with treatment with direct oral anticoagulants (DOACs). To describe the characteristics and outcomes of those patients. METHODS: A 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. RESULTS: 37 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. CONCLUSIONS: DOACs 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.
Entities:
Keywords:
atrial fibrillation; bleeding; direct oral anticoagulants; gastrointestinal haemorrhage; hospitalisation; intracranial haemorrhage; non–vitamin K antagonist oral anticoagulants; pharmacovigilance; safety
Authors: Manesh R Patel; Kenneth W Mahaffey; Jyotsna Garg; Guohua Pan; Daniel E Singer; Werner Hacke; Günter Breithardt; Jonathan L Halperin; Graeme J Hankey; Jonathan P Piccini; Richard C Becker; Christopher C Nessel; John F Paolini; Scott D Berkowitz; Keith A A Fox; Robert M Califf Journal: N Engl J Med Date: 2011-08-10 Impact factor: 91.245
Authors: Ron Pisters; Deirdre A Lane; Robby Nieuwlaat; Cees B de Vos; Harry J G M Crijns; Gregory Y H Lip Journal: Chest Date: 2010-03-18 Impact factor: 9.410
Authors: Roxana Mehran; Sunil V Rao; Deepak L Bhatt; C Michael Gibson; Adriano Caixeta; John Eikelboom; Sanjay Kaul; Stephen D Wiviott; Venu Menon; Eugenia Nikolsky; Victor Serebruany; Marco Valgimigli; Pascal Vranckx; David Taggart; Joseph F Sabik; Donald E Cutlip; Mitchell W Krucoff; E Magnus Ohman; Philippe Gabriel Steg; Harvey White Journal: Circulation Date: 2011-06-14 Impact factor: 29.690
Authors: Christopher B Granger; John H Alexander; John J V McMurray; Renato D Lopes; Elaine M Hylek; Michael Hanna; Hussein R Al-Khalidi; Jack Ansell; Dan Atar; Alvaro Avezum; M Cecilia Bahit; Rafael Diaz; J Donald Easton; Justin A Ezekowitz; Greg Flaker; David Garcia; Margarida Geraldes; Bernard J Gersh; Sergey Golitsyn; Shinya Goto; Antonio G Hermosillo; Stefan H Hohnloser; John Horowitz; Puneet Mohan; Petr Jansky; Basil S Lewis; Jose Luis Lopez-Sendon; Prem Pais; Alexander Parkhomenko; Freek W A Verheugt; Jun Zhu; Lars Wallentin Journal: N Engl J Med Date: 2011-08-27 Impact factor: 91.245
Authors: Stuart J Connolly; Michael D Ezekowitz; Salim Yusuf; John Eikelboom; Jonas Oldgren; Amit Parekh; Janice Pogue; Paul A Reilly; Ellison Themeles; Jeanne Varrone; Susan Wang; Marco Alings; Denis Xavier; Jun Zhu; Rafael Diaz; Basil S Lewis; Harald Darius; Hans-Christoph Diener; Campbell D Joyner; Lars Wallentin Journal: N Engl J Med Date: 2009-08-30 Impact factor: 91.245
Authors: Robert P Giugliano; Christian T Ruff; Eugene Braunwald; Sabina A Murphy; Stephen D Wiviott; Jonathan L Halperin; Albert L Waldo; Michael D Ezekowitz; Jeffrey I Weitz; Jindřich Špinar; Witold Ruzyllo; Mikhail Ruda; Yukihiro Koretsune; Joshua Betcher; Minggao Shi; Laura T Grip; Shirali P Patel; Indravadan Patel; James J Hanyok; Michele Mercuri; Elliott M Antman Journal: N Engl J Med Date: 2013-11-19 Impact factor: 91.245
Authors: Sally Tamayo; W Frank Peacock; Manesh Patel; Nicholas Sicignano; Kathleen P Hopf; Larry E Fields; Troy Sarich; Shujian Wu; Daniel Yannicelli; Zhong Yuan Journal: Clin Cardiol Date: 2015-01-14 Impact factor: 2.882