Why is this study important? 

The ADAPT-TAVR trial did not show benefit for routine use of anticoagulation with edoxaban to prevent valve thrombosis and stroke.

Should I change my practice because of these findings? 

Based on this study, current practice with single or dual anti-platelet therapy after TAVR without routine use of anticoagulation should continue. 

What question was the study supposed to answer? 

The goal of the study was to show whether routine use of anticoagulation after TAVR prevented valve leaflet thrombosis and secondarily if this would reduce the incidence of stroke.  

What did the study show? 

The ADAPT-TAVR trial randomized 229 patients in an open-label fashion to receive dual antiplatelet therapy (DAPT) with aspirin and clopidogrel or edoxaban monotherapy.  115 patients were in the edoxaban group and 120 in the DAPT group.  4D-CT scans were then obtained at 6-months with presence of leaflet thrombosis as the primary endpoint.  There was a trend towards reduction in leaflet thrombosis in the edoxaban group (9.8% vs. 18.4%) but this was not statistically significant (p=0.076).  There was no difference in clinical stroke of MRI new cerebral lesions between groups.  Death was numerically more common in the edoxaban group 2.7% vs. 1.7% but not statistically significant (p=0.68). 

How good was the approach/methodology?

ADAPT-TAVR was well designed but small and underpowered to draw conclusions about the role of anticoagulation to prevent leaflet thrombosis. 

All editors: Jared M. O'Leary, MD