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Fixed-Dose Versus Adjusted-Dose Warfarin in Patients with Prosthetic Heart Valves
in a Peri-Urban Impoverished Population Patients with mechanical heart valves are dependent on adequate anticoagulation. When patients are young, geographically dispersed and socioeconomically deprived, hospital attendance is erratic and compliance with anticoagulation difficult. The need exists for anticoagulation that requires neither regular visits nor adjustment of the warfarin dose. A five-year prospective randomized double-blind study was undertaken to compare the efficacy and safety of fixed-dose versus adjusted-dose warfarin. Postopoeratively, 296 patients received either fixed-dose or adjusted-dose warfarin. In those on fixed-dose warfarin, 63% of INRs were 2.0-4.5 compared with 64% after adjusted-dose warfarin. Mean follow up was 2.4 years in both groups; total follow up was 725 patient-years. Seven -patients on fixed-dose warfarin died, and five on adjusted-dose (p = 0.52); 13 and four thrombotic events occurred in these groups, respectively (p = 0.02), and 12 major hemorrhagic events in each group. In this population, fixed-dose warfarin was associated with increased thromboembolic events, but no increase in mortality or hemorrhagic events. Fixed-dose warfarin may be acceptable when conventional anticoagulation is impracticable. |
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