Dabigatran versus warfarin after mechanical mitral valve replacement in the swine model.

Abstract

Mechanical heart valve replacement is an absolute indication for anticoagulation. We report our experience comparing dabigatran to warfarin as thromboembolic prophylaxis after mechanical mitral valve replacement in the swine model.
Nineteen swine underwent mitral valve replacement with a regulatory approved, 27 mm mechanical valve. Two control groups consisted of three animals receiving no anticoagulation and five animals receiving warfarin (5 mg once a day [QD], adjusted to maintain international normalized ratio [INR] from 2.0 to 2.5). The experimental group consisted of 11 animals receiving dabigatran (20 mg/kg twice a day [BID]). The study period was 90 days. The primary outcome was animal mortality; secondary outcomes included presence of thrombus and bleeding complications.
The experimental group had four full-term survivors (40.0%); there were no full-term survivors in either control group. The average length of survival was 50.3 days in the experimental group compared with 18.7 and 15.6 days for the no anticoagulation and warfarin groups, respectively (p = .017). Valve thrombus was observed in all study groups. Hemorrhagic complications were present in 40% of the warfarin group and 27% of the dabigatran group.
There was a significant mortality benefit to the use of dabigatran as thromboembolic prophylaxis when compared with warfarin in the setting of mechanical heart valve replacement in the swine model. There was also a decreased incidence of bleeding complications in the dabigatran group compared with the warfarin group. Valve thrombus was observed in all study groups. Any conclusions regarding the rate of thrombus formation are outside the scope of this study and merit further investigation.