Edoxaban vs DAPT: Which is better against post-TAVR leaflet thrombosis?

The incidence of leaflet thrombosis in patients without an indication for long-term anticoagulation after transcatheter aortic-valve replacement (TAVR) appears to be lower with edoxaban than with dual antiplatelet therapy (DAPT) although not significantly so, according to the results of the open-label ADAPT-TAVR trial.

ADAPT-TAVR included 229 patients who had undergone successful TAVR and did not have an indication for anticoagulation. They were randomized to receive edoxaban or DAPT (aspirin plus clopidogrel).

At 6 months, the primary outcome of the incidence of leaflet thrombosis, assessed using four-dimensional computed tomography, was numerically lower in the edoxaban group than in the DAPT group (9.8 percent vs 18.4 percent; absolute difference, −8.5 percent, 95 percent confidence interval [CI], −17.8 to 0.8; p=0.076).

There were no significant between-group differences in the key secondary outcomes such as the occurrence of new cerebral lesions on brain MRI (edoxaban vs DAPT: 25.0 percent vs 20.2 percent; difference, 4.8 percent, 95 percent CI, −6.4 to 16.0) and median total new lesion number and volume.

The two groups were also similar in terms of the proportion of patients with worsening of neurological and neurocognitive function as well as the incidence of any or major bleeding events.

On further analysis, the presence or extent of leaflet thrombosis showed no significant association with new cerebral lesions and a change of neurological or neurocognitive function.

The investigators acknowledged that ADAPT-TAVR was underpowered. As such, the results should be considered hypothesis-generating, and further studies are needed.