Edoxaban Versus Dual Antiplatelet Therapy For Valve Thrombosis And Cerebral Thromboembolism After Transcatheter Aortic-valve Replacement: A Randomized ADAPT-TAVR Trial

Presented at ACC.22 by Duk-Woo Park, MD, PhD (Seoul, Korea)

Introduction and methods

This multicenter, open-label randomized trial investigated whether edoxaban, compared to DAPT can reduce leaflet thrombosis, cerebral thromboembolism and neurological/neurocognitive dysfunction after transcatheter aortic-valve replacement (TAVR).

A total of 229 patients who had undergone successful TAVR and without an indication for long-term anticoagulation were randomized to receive edoxaban (n=110, 60 mg or 30 mg once daily) or DAPT (aspirin [100 mg once daily] plus clopidogrel [75 mg once daily]) for 6 months.

The primary endpoint was incidence of valve leaflet thrombosis on four-dimensional CT at 6 months. Key secondary endpoints were number of new cerebral lesions and total new lesion volume on brain MRI and changes in neurological/neurocognitive function tests between baseline and 6 months.

Results

• Incidence of leaflet thrombosis was numerically lower in the edoxaban group compared with the DAPT group, however, this difference was not statistically significant (9.8% vs. 18.4%, difference -8.5%, 95% CI -17.8% to 0.8%, Risk ratio 0.53, P=0.076).
• There was no significant difference in presence, number or volume of new cerebral lesions between the two groups.
• There was also no difference in the proportion of patients with worsening neurological or neurocognitive function between the two groups.
• The study found no association between subclinical leaflet thrombosis and new cerebral lesions and change of neurological/neurocognitive function.

Conclusion

In patients without an indication for long-term anticoagulation after successful TAVR, 6-months treatment with edoxaban, compared with DAPT, did not results in significant reductions in incidence of leaflet thrombosis, cerebral thromboembolism, or neurological/neurocognitive dysfunction.

– Our coverage of ACC.22 is based on the information provided during the congress –

The results of this study were simultaneously published in Circulation.