Subclinical leaflet thickening and reduced leaflet motion of bioprosthetic aortic valves have been documented using four-dimensional computed tomography (4D-CT). The aim of this study was to establish whether anticoagulation with rivaroxaban can reduce these phenomena after transcatheter aortic-valve replacement.
In this substudy of the main GALILEO trial, the patients were randomized to the 3-month treatment with combination of 10 mg rivaroxaban and aspirin or treatment with combination of clopidogrel with aspirin. Treatment with rivaroxaban was more effective than an antiplatelet-based strategy in preventing subclinical leaflet motion abnormalities.
However, in the main trial, the rivaroxaban-based strategy was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than the antiplatelet-based strategy.