title: Self-Management of Anticoagulant Therapy in Mechanical Heart Valve Patients: A Matched Cohort Study.
abstract: BACKGROUND
  Patient-self-management (PSM) of oral anticoagulant therapy with vitamin K antagonists for mechanical heart valves has demonstrated efficacy in randomized controlled trials. However, the effectiveness of PSM in clinical practice has only been investigated in small trials. Our aim was to evaluate the effectiveness of PSM of oral anticoagulant therapy in mechanical heart valve patients.
  
  
  METHODS
  We conducted a matched cohort study: cases were patients with a mechanical heart valve performing PSM affiliated with Aarhus University Hospital or Aalborg University Hospital, Denmark, in the period 1996 to 2012 (n = 615). Prospectively registered patient data were obtained from databases at two hospitals, and cross linkage between these databases and national patient registries provided detailed information on comorbidities and events. Control patients were matched (on sex, date of birth, year of first valve surgery, and grouped valve position) in a ratio of 5:1 (n = 3,075) with patients receiving conventional management who were randomly selected within the match group. The effectiveness and safety was estimated using major bleeding and thromboembolic events and death as outcomes.
  
  
  RESULTS
  We observed low event rates in the PSM group. After 5 years, PSM was associated with a lower risk of all-cause mortality compared with conventional management (adjusted hazard ratio of 0.49, 95% confidence interval: 0.34 to 0.71). The hazard ratios for thromboembolism and major bleeding were 0.91 (95% confidence interval: 0.66 to 1.24) and 0.83 (95% confidence interval: 0.56 to 1.22).
  
  
  CONCLUSIONS
  Owing to superior clinical effectiveness, self-managed oral anticoagulant therapy may potentially improve the standard of care for patients with mechanical heart valves.
authors.affiliation: Department of Cardiothoracic and Vascular Surgery and Institute of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark. Electronic address: tdc@clin.au.dk.
authors.forename: Thomas Decker
authors.initials: TD
authors.lastname: Christensen
authors.affiliation: Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Faculty of Medicine, Aalborg University, Aalborg, Denmark; Unit of Clinical Biostatistics and Bioinformatics, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: Flemming
authors.initials: F
authors.lastname: Skjøth
authors.affiliation: Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Faculty of Medicine, Aalborg University, Aalborg, Denmark; Unit of Clinical Biostatistics and Bioinformatics, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: Peter Brønnum
authors.initials: PB
authors.lastname: Nielsen
authors.affiliation: Department of Cardiothoracic and Vascular Surgery and Institute of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Marianne
authors.initials: M
authors.lastname: Maegaard
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, Aarhus University Hospital, Aarhus, Denmark; Department of Cardiology, AF Study Group, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: Torben Bjerregaard
authors.initials: TB
authors.lastname: Larsen
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D001705:Bioprosthesis; D016022:Case-Control Studies; D016001:Confidence Intervals; D003266:Continuity of Patient Care / Q000458:organization & administration*; D016208:Databases, Factual; D003718:Denmark; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance / Q000706:statistics & numerical data*; D061214:Patient Safety; D016016:Proportional Hazards Models; D011475:Prosthesis Failure; D012016:Reference Values; D012189:Retrospective Studies; D018570:Risk Assessment; D012648:Self Care / Q000379:methods*; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants