title: Sex differences in treatment quality of self-managed oral anticoagulant therapy: 6,900 patient-years of follow-up.
abstract: BACKGROUND
  Patient-self-management (PSM) of oral anticoagulant therapy with vitamin K antagonists has demonstrated efficacy in randomized, controlled trials. However, the effectiveness and efficacy of PSM in clinical practice and whether outcomes are different for females and males has been sparsely investigated.The objective is to evaluate the sex-dependent effectiveness of PSM of oral anticoagulant therapy in everyday clinical practice.
  
  
  METHODS
  All patients performing PSM affiliated to Aarhus University Hospital and Aalborg University Hospital, Denmark in the period 1996-2012 were included in a case-series study. The effectiveness was estimated using the following parameters: stroke, systemic embolism, major bleeding, intracranial bleeding, gastrointestinal bleeding, death and time spent in the therapeutic international normalized ratio (INR) target range. Prospectively registered patient data were obtained from two databases in the two hospitals. Cross-linkage between the databases and national registries provided detailed information on the incidence of death, bleeding and thromboembolism on an individual level.
  
  
  RESULTS
  A total of 2068 patients were included, representing 6,900 patient-years in total. Males achieved a significantly better therapeutic INR control than females; females spent 71.1% of the time within therapeutic INR target range, whereas males spent 76.4% (p<0.0001). Importantly, death, bleeding and thromboembolism were not significantly different between females and males.
  
  
  CONCLUSIONS
  Among patients treated with self-managed oral anticoagulant therapy, males achieve a higher effectiveness than females in terms of time spent in therapeutic INR range, but the incidence of major complications is low and similar in both sexes.
authors.affiliation: Department of Cardiothoracic and Vascular Surgery & Institute of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Hanna
authors.initials: H
authors.lastname: Nilsson
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Erik Lerkevang
authors.initials: EL
authors.lastname: Grove
authors.affiliation: Department of Cardiology, Centre for Cardiovascular Research, Aalborg University Hospital, Aalborg, Denmark; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, The Faculty of Medicine, Aalborg University, Aalborg, Denmark.
authors.forename: Torben Bjerregaard
authors.initials: TB
authors.lastname: Larsen
authors.affiliation: Aalborg Thrombosis Research Unit, Department of Clinical Medicine, The Faculty of Medicine, Aalborg University, Aalborg, Denmark.
authors.forename: Peter Brønnum
authors.initials: PB
authors.lastname: Nielsen
authors.affiliation: Aalborg Thrombosis Research Unit, Department of Clinical Medicine, The Faculty of Medicine, Aalborg University, Aalborg, Denmark.
authors.forename: Flemming
authors.initials: F
authors.lastname: Skjøth
authors.affiliation: Department of Cardiothoracic and Vascular Surgery & Institute of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Marianne
authors.initials: M
authors.lastname: Maegaard
authors.affiliation: Department of Cardiothoracic and Vascular Surgery & Institute of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Thomas Decker
authors.initials: TD
authors.lastname: Christensen
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D003718:Denmark / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000097:blood / Q000139:chemically induced / Q000401:mortality; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D012646:Self Administration; D012727:Sex Characteristics; D013923:Thromboembolism / Q000097:blood / Q000188:drug therapy* / Q000401:mortality*
chemical_list: D000925:Anticoagulants