Edoxaban vs. Vitamin K Antagonist for Atrial Fibrillation After Transcatheter Aortic Valve Replacement in Japanese Patients - A Subanalysis of the ENVISAGE-TAVI AF Trial

Circ J. 2022 Oct 25;86(11):1756-1763. doi: 10.1253/circj.CJ-22-0093. Epub 2022 Aug 11.

Abstract

Background: Japanese patients undergoing transcatheter aortic valve replacement (TAVR) are often female and have a small body size, potentially impacting bleeding risk with antithrombotic therapy. Outcomes of direct oral anticoagulant use in these patients with atrial fibrillation (AF) need to be clarified.Methods and Results: This prespecified analysis included Japanese patients from ENVISAGE-TAVI AF, a prospective, randomized, open-label, adjudicator-masked trial that compared treatment with edoxaban and vitamin K antagonists (VKAs) in patients with AF after TAVR. The primary efficacy and safety outcomes were net adverse clinical events (NACE; composite of all-cause death, myocardial infarction, ischemic stroke, systemic embolic event, valve thrombosis, and International Society on Thrombosis and Haemostasis [ISTH]-defined major bleeding) and ISTH-defined major bleeding, respectively. Intention-to-treat (ITT) and on-treatment analyses were performed. Overall, 159 Japanese patients were enrolled (edoxaban group: 82, VKA group: 77) and followed for on average 483 days. Mean patient age was 83.8 years; 52.2% were female. In the ITT analysis, NACE rates were 10.9%/year with edoxaban and 12.5%/year with VKA (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.38-1.90); major bleeding occurred in 8.9%/year and 7.3%/year, respectively (HR, 1.17; 95% CI, 0.45-3.05). In edoxaban- and VKA-treated patients, rates of ischemic stroke were 1.8%/year and 1.0%/year, respectively; fatal bleeding rates were 0.9%/year and 2.0 %/year. On-treatment results were similar to ITT.

Conclusions: In Japanese patients with AF after successful TAVR, edoxaban and VKA treatment have similar safety and efficacy profiles.

Keywords: Atrial fibrillation; Direct oral anticoagulant; Transcatheter aortic valve replacement; Vitamin K antagonist.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged, 80 and over
  • Anticoagulants / adverse effects
  • Atrial Fibrillation* / complications
  • Female
  • Fibrinolytic Agents / therapeutic use
  • Hemorrhage / chemically induced
  • Humans
  • Ischemic Stroke*
  • Japan
  • Male
  • Prospective Studies
  • Stroke* / epidemiology
  • Stroke* / etiology
  • Stroke* / prevention & control
  • Transcatheter Aortic Valve Replacement* / adverse effects
  • Treatment Outcome
  • Vitamin K

Substances

  • edoxaban
  • Fibrinolytic Agents
  • Anticoagulants
  • Vitamin K