Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR
In this study (n=1426), edoxaban was non-inferior to vitamin K antagonists in terms of the primary composite endpoint (death, MI, ischaemic stroke, systemic thromboembolism, valve thrombosis, major bleeding) in people with AF after successful TAVR (HR 1.05; 95% 0.85-1.31; p=0.01)
Source:
New England Journal of Medicine
SPS commentary:
Non-inferiority of edoxaban was demonstrated as the upper boundary of the 95% CI for the hazard ratio for the efficacy endpoint (1.31) did not exceed 1.38. Rates of major bleeding were however higher with edoxaban (9.7 per 100 person-years versus 7.0 per 100 person-years with vitamin K antagonists; HR 1.40; 95% CI 1.03 to 1.91; P=0.93 for non-inferiority); this difference was mainly due to more gastrointestinal bleeding with edoxaban.