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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.