title: Major bleeding complications in patients treated with direct oral anticoagulants: One-year observational study in a Paris Hospital.
abstract: Direct oral anticoagulants (DAOC) are indicated for the treatment of venous thromboembolism and the prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation. Given their advantages and friendly use for patient, the prescription of long term DOAC therapy has rapidly increased both as first line treatment while initiating anticoagulation and as a substitute to vitamins K antagonist (VKA) in poorly controlled patients. However, DOAC therapy can also be associated with significant bleeding complications, and in the absence of specific antidote at disposal, treatment of serious hemorrhagic complications under DOAC remains complex. We report and discuss herein five cases of major hemorrhagic complications under DOAC, which were reported to the pharmacological surveillance department over one year at Saint-Louis University Hospital (Paris, France). We further discuss the need for careful assessment of the risk/benefit ratio at time of starting DOAC therapy in daily clinical practice.
authors.affiliation: Service de pharmacie, hôpital Saint-Louis, Assistance publique-Hôpitaux de Paris, 1, avenue Claude-Vellefaux, 75010 Paris, France.
authors.forename: L
authors.initials: L
authors.lastname: Deville
authors.affiliation: Unité de médecine interne et pathologie vasculaire, hôpital Saint-Louis, Assistance publique-Hôpitaux de Paris, 1, avenue Claude-Vellefaux, 75010 Paris, France; Service de médecine interne, CHU de Treichville, Abidjan, Côte d'Ivoire.
authors.forename: M
authors.initials: M
authors.lastname: Konan
authors.affiliation: Unité de médecine interne et pathologie vasculaire, hôpital Saint-Louis, Assistance publique-Hôpitaux de Paris, 1, avenue Claude-Vellefaux, 75010 Paris, France.
authors.forename: A
authors.initials: A
authors.lastname: Hij
authors.affiliation: Unité de pharmacologie, hôpital Saint-Louis, Assistance publique-Hôpitaux de Paris, 1, avenue Claude-Vellefaux, 75010 Paris, France.
authors.forename: L
authors.initials: L
authors.lastname: Goldwirt
authors.affiliation: Service des urgences, hôpital Saint-Louis, Assistance publique-Hôpitaux de Paris, 1, avenue Claude-Vellefaux, 75010 Paris, France.
authors.forename: O
authors.initials: O
authors.lastname: Peyrony
authors.affiliation: Service de réanimation chirurgicale, hôpital Saint-Louis, Assistance publique-Hôpitaux de Paris, 1, avenue Claude-Vellefaux, 75010 Paris, France.
authors.forename: F
authors.initials: F
authors.lastname: Fieux
authors.affiliation: Service de pharmacie, hôpital Saint-Louis, Assistance publique-Hôpitaux de Paris, 1, avenue Claude-Vellefaux, 75010 Paris, France.
authors.forename: P
authors.initials: P
authors.lastname: Faure
authors.affiliation: Service de pharmacie, hôpital Saint-Louis, Assistance publique-Hôpitaux de Paris, 1, avenue Claude-Vellefaux, 75010 Paris, France.
authors.forename: I
authors.initials: I
authors.lastname: Madelaine
authors.affiliation: Service d'anesthésie réanimation, hôpital Saint-Louis, Assistance publique-Hôpitaux de Paris, 1, avenue Claude-Vellefaux, 75010 Paris, France.
authors.forename: S
authors.initials: S
authors.lastname: Villiers
authors.affiliation: Unité de médecine interne et pathologie vasculaire, hôpital Saint-Louis, Assistance publique-Hôpitaux de Paris, 1, avenue Claude-Vellefaux, 75010 Paris, France.
authors.forename: D
authors.initials: D
authors.lastname: Farge-Bancel
authors.affiliation: Service d'hématologie biologique, CHU Timone, Assistance publique-Hôpitaux de Marseille, 264, rue Saint-Pierre, 13385 Marseille, France; Inserm UMRS 1076, VRCM, Aix-Marseille université, 13385 Marseille, France. Electronic address: Corinne.Frere@ap-hm.fr.
authors.forename: C
authors.initials: C
authors.lastname: Frère
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000638:Amiodarone / Q000009:adverse effects / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000150:complications; D000069604:Dabigatran / Q000008:administration & dosage / Q000009:adverse effects*; D017707:Erythrocyte Transfusion; D065427:Factor Xa Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced; D006470:Hemorrhage / Q000139:chemically induced* / Q000453:epidemiology / Q000628:therapy; D006785:Hospitals, University; D006801:Humans; D020300:Intracranial Hemorrhages / Q000139:chemically induced; D007674:Kidney Diseases / Q000150:complications; D008297:Male; D010297:Paris / Q000453:epidemiology; D060735:Pharmacovigilance; D012307:Risk Factors; D000069552:Rivaroxaban / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D065427:Factor Xa Inhibitors; D000069552:Rivaroxaban; D000069604:Dabigatran; D000638:Amiodarone
keywords: Contraindications; Direct oral anticoagulants; Major hemorrhage; Precautions for use; Risk/benefit ratio