Anticoagulant treatment reduces the incidence of death and cardioembolic events in patients
with atrial fibrillation or prosthetic heart valve and the incidence of death and recurrences
in patients with VTE. Warfarin and similar vitamin K antagonists (VKA) have been the standard
therapy for patients with a metallic valve, or bioprosthesis with atrial fibrillation (AF).
The Dabigatran versus Warfarin in Patients with Mechanical Heart Valves (RE-ALIGN) trial
comparing dabigatran etexilate to warfarin was the only randomized controlled study in
patient with mechanical valve prosthesis, but it was terminated prematurely because of an
excess of thromboembolic and bleeding events among patients in the dabigatran group. To date,
novel oral anticoagulants (NOACs) have shown to be not both safe and or effective for
patients with mechanical valves.