Van Mieghem NM, Unverdorben M, Hengstenberg C, et al. - The data illustrated that edoxaban was noninferior to vitamin K antagonists as determined by a hazard ratio margin of 38% for a composite primary outcome of adverse clinical events in patients with mainly prevalent atrial fibrillation who underwent successful transcatheter aortic valve replacement (TAVR). Compared with vitamin K antagonists, the incidence of major bleeding was higher with edoxaban.

• Researchers performed a multicenter, prospective, randomized, open-label, adjudicator-masked trial comparing edoxaban with vitamin K antagonists in patients with prevalent or incident atrial fibrillation as the indication for oral anticoagulation after successful TAVR.

• The study enrolled a total of 1,426 patients (713 in each group). In this study, 82.1 years was the mean age of the patients, and 47.5% of the patients were women.

• The findings demonstrated that almost all the patients had atrial fibrillation before TAVR.

• The results showed that 17.3 per 100 person-years was the rate of the composite primary efficacy outcome in the edoxaban group and 16.5 per 100 person-years in the vitamin K antagonist group (hazard ratio, 1.05; 95% confidence interval [CI], 0.85 to 1.31; P=0.01 for noninferiority).

• It was shown that rates of major bleeding were 9.7 per 100 person-years and 7.0 per 100 person-years, respectively (hazard ratio, 1.40; 95% CI, 1.03 to 1.91; P=0.93 for noninferiority); the difference between groups was mainly due to more gastrointestinal bleeding with edoxaban.

• In the edoxaban group, rates of death from any cause or stroke were 10.0 per 100 person-years, and 11.7 per 100 person-years in the vitamin K antagonist group (hazard ratio, 0.85; 95% CI, 0.66 to 1.11).