Edoxaban vs vitamin K antagonists in Japanese patients after TAVR with atrial fibrillation: a subanalysis of the ENVISAGE-TAVI AF trial

A subanalysis of the ENVISAGE-TAVI AF trial found no difference in safety and efficacy between edoxaban and vitamin K antagonist (VKA) treatment in Japanese patients with atrial fibrillation who underwent successful TAVR, Dr. Yusuke Watanabe of Teikyo University Hospital reported in the online edition of Circulation Journal.

In a subanalysis of the ENVISAGE-TAVI AF trial, Dr. Watanabe and colleagues compared the clinical outcomes of 159 Japanese patients with atrial fibrillation who had undergone successful TAVR included in the trial to those in the edoxaban (82 patients) and VKA (77 patients) groups.

The mean age of eligible patients was 83.8 years and 52.2% were women. Patients were followed for a mean of 483 days, and ITT analysis showed that NACE (all-cause mortality, MI, ischemic stroke, systemic embolic events, valve thrombosis, and severe bleeding as defined by ISTH) was 10.9%/year in the edoxaban group and 12.5%/year in the VKA group (HR 0.85 [95% CI 0.38-1.90]) and severe hemorrhage occurred in 8.9%/year and 7.3%/year (HR 1.17 [95%CI 0.45-3.05]), respectively. The incidence of ischemic stroke was 1.8%/year in the edoxaban group and 1.0%/year in the VKA group, and fatal bleeding was 0.9% and 2.0%, respectively. The analysis of actual patients treated was similar to that of the ITT analysis.

Dr. Watanabe concluded, "In Japanese patients with atrial fibrillation after successful TAVR, the safety and efficacy of treatment with edoxaban and VKA were similar. Because of the relatively small sample size in this study, studies with designs that can detect treatment effects in Japanese patients are needed to confirm these results."

Watanabe Y, et al. Circ J. 2022; in press

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