Self-Management of Anticoagulant Therapy in Mechanical Heart Valve Patients: A Matched Cohort Study.

Abstract

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. 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. 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). Owing to superior clinical effectiveness, self-managed oral anticoagulant therapy may potentially improve the standard of care for patients with mechanical heart valves.