Objective
to assess the incidence of clinically relevant non-major or major bleeding during treatment with Edoxaban compared to Vit K antagonists in patients with atrial fibrillation undergoing PCI
Study
multicentre, open-label phase 3b non-inferiority randomised study (margin 1.20)
Population
patients with atrial fibrillation requiring oral anticoagulation who had successful PCI in all-comers
Endpoints
composite of major or clinically relevant non-major (CRNM) bleeding (ISTH criteria) during 12-month follow-up
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Conclusion
in patients with atrial fibrillation and successful PCI edoxaban regimen was non-inferior to Vit K antagonist regimen with respect to bleeding
Vranckx et al. Lancet. 2019;394:1335-43