This follows preliminary analysis of a phase 3 GALILEO trial showing risks of all-cause death and bleeding post- transcatheter aortic valve replacement were approximately doubled in patients assigned to a rivaroxaban-based anticoagulation strategy compared with those assigned to receive an antiplatelet-based strategy (clopidogrel and aspirin)
The direct-acting oral anticoagulants apixaban and edoxaban have not been studied in patients with prosthetic heart valves and their use is also not recommended in these patients; the use of dabigatran is contraindicated in patients with prosthetic heart valves requiring anticoagulant treatment.