No reduction in cerebral thromboembolism with DOAC after TAVR
ACC 2022 Treatment with edoxaban, compared with DAPT, did not result in significant reductions in incidence of leaflet thrombosis, cerebral thromboembolism, or neurological/neurocognitive dysfunction in patients without an indication for long-term anticoagulation after successful TAVR.
Edoxaban Versus Dual Antiplatelet Therapy For Valve Thrombosis And Cerebral Thromboembolism After Transcatheter Aortic-valve Replacement: A Randomized ADAPT-TAVR Trial
News - Apr. 5, 2022
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 –