title: Major bleeding with vitamin K antagonists or direct oral anticoagulants in real-life.
abstract: BACKGROUND
  Limited data are available on major bleeding (MB) occurring during treatment with vitamin K (VKAs) or direct oral anticoagulants (DOACs) outside clinical trials.
  
  
  METHODS
  Patients hospitalized for MB while on treatment with VKAs or DOACs were included in a multicenter study to compare clinical presentation, management and outcome of bleeding. The primary study outcome was death at 30days.
  
  
  RESULTS
  Between September 2013 and September 2015, 806 patients were included in the study, 76% on VKAs and 24% on DOACs. MB was an intracranial hemorrhage in 51% and 21% patients on VKAs or DOACs, respectively (Odds Ratio [OR] 3.79; 95% confidence interval [CI] 2.59-5.54) a gastrointestinal bleeding in 46% and 25% patients on DOACs and VKAs, respectively (OR 2.62; 95% CI 1.87-3.68). Death at 30days occurred in 130 patients (16%), 18% and 9% of VKA and DOAC patients (HR 1.95; 95% CI 1.19-3.22, p=0.008). The rate of death at 30days was similar in VKA and DOAC patients with intracranial hemorrhage (26% and 24%; HR 1.05, 95% CI 0.54-2.02) and gastrointestinal bleeding (11% and 7%; HR 1.46, 95% CI 0.57-3.74) and higher in VKA than DOAC patients with other MBs (10% and 3%; HR 3.42, 95% CI 0.78-15.03).
  
  
  CONCLUSIONS
  Admission for ICH is less frequent for DOAC patients compared with VKA patients. Admission for gastrointestinal MB is more frequent for DOAC as compared to VKA patients. Mortality seems lower in patients with MBs while on DOACs than VKAs but this finding varies across different types of MBs.
authors.affiliation: Internal and Cardiovascular Medicine-Stroke Unit, University of Perugia, Italy. Electronic address: cecilia.becattini@unipg.it.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Becattini
authors.affiliation: Internal and Cardiovascular Medicine-Stroke Unit, University of Perugia, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Franco
authors.affiliation: Center for Vascular Medicine, University Hospital "Carl Gustav Carus", Technische Universität Dresden, Dresden, Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Beyer-Westendorf
authors.affiliation: Internal Medicine, Santa Maria Nuova Hospital, Firenze, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Masotti
authors.affiliation: Emergency Medicine, Ospedali Riuniti Umberto I - Lancisi- Salesi, Ancona, Italy.
authors.forename: Cinzia
authors.initials: C
authors.lastname: Nitti
authors.affiliation: Department of Emergency Medicine, Careggi University Hospital, Firenze, Italy.
authors.forename: Simone
authors.initials: S
authors.lastname: Vanni
authors.affiliation: Emergency Medicine, Ospedale Maggiore, Lodi, Italy.
authors.forename: Giorgia
authors.initials: G
authors.lastname: Manina
authors.affiliation: Emergency Medicine, Ospedale Cattinara, Trieste, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Cattinelli
authors.affiliation: Internal Medicine, University of Siena, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Cappelli
authors.affiliation: Emergency Medicine, Santa Maria della Misericordia Hospital, Udine, Italy.
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Sbrojavacca
authors.affiliation: Internal Medicine, Santa Croce Hospital, Cuneo, Italy.
authors.forename: Fulvio
authors.initials: F
authors.lastname: Pomero
authors.affiliation: Center for Vascular Medicine, University Hospital "Carl Gustav Carus", Technische Universität Dresden, Dresden, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Marten
authors.affiliation: Internal and Cardiovascular Medicine-Stroke Unit, University of Perugia, Italy.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Agnelli
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000150:complications; D005260:Female; D006470:Hemorrhage / Q000453:epidemiology*; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D015996:Survival Rate; D054556:Venous Thromboembolism / Q000150:complications; D014812:Vitamin K / Q000037:antagonists & inhibitors* / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D014812:Vitamin K
keywords: Anticoagulants; Apixaban; Dabigatran; Intracranial hemorrhage; Major bleeding; Rivaroxaban