NOAC non-inferior to VKA for net adverse clinical events in AF patients after TAVI

Edoxaban Versus Vitamin K Antagonists After Transcatheter Aortic Valve Implantation in Patients with Atrial Fibrillation – The ENVISAGE-TAVI AF Trial

Presented at the ESC congress 2021 by: George Dangas, MD, PhD New York, NY, USA

Introduction and methods

The ENVISAGE-TAVI AF trial was a prospective, open-label, blinded evaluation, non-inferiority trial that compared edoxaban-based regimen vs. VKA-based regimen in AF patients. Patients who underwent successful completion of TAVI were enrolled and randomized from evening of TAVI to 5 days to either edoxaban 60 mg/day with or without antiplatelet therapy or to vitamin K antagonists (with a target INR of 2-3) with or without antiplatelet therapy. Primary endpoint was net adverse clinical events (NACE), including ischemic and bleeding endpoints. Safety endpoint was major bleeding.

Main results

• Edoxaban regimen was non-inferior to VKA regimen for the outcome of NACE (HR 1.05, 95%CI: 0.85-1.21, P=0.014).
• Major bleeding was higher in the edoxaban group compared to the VKA group (HR 1.40, 95%CI: 1.03-1.91, P=0.927). This was driven by higher major GI bleedings.
• Individual endpoints of ischemic stroke and all-cause death were not different between the edoxaban group and the VKA group.
• Prespecified analysis of outcomes by adjustment of edoxaban dose showed that major bleeding and major GI bleeding was similar for those who fulfilled dose adjustment criteria in the edoxaban group compared to the VKA group.
• Subgroup analysis of patients with antiplatelet therapy showed that edoxaban was associated with higher rates of major bleeding compared to VKA.

Conclusion

This non-inferiority trial demonstrated that edoxaban resulted in similar rate of NACE as VKA in AF patients who had undergone successful TAVI. Major bleeding rates were higher in those receiving edoxaban, which were mainly driven by major GI bleeding.

• Our reporting is based on the information provided at the ESC Congress -

The results of were simultaneously presented in N Eng J Med