EP News: Clinical

  • N.A. Mark Estes III
    Address reprint requests and correspondence: Dr. N.A. Mark Estes III, UPMC Heart and Vascular Institute, Presbyterian Hospital, 200 Lothrop St, 3rd Floor South Tower (WE352.1), Pittsburgh, PA 15213.
    UPMC Heart and Vascular Institute, Presbyterian Hospital, Pittsburgh, Pennsylvania
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Published:November 04, 2020DOI:
      Okumura et al (N Engl J Med 2020;383:1735–1745, PMID 32865374) conducted a multicenter, randomized, double-blind, placebo-controlled trial comparing a once-daily, 15-mg dose of edoxaban (E) with placebo in elderly patients (age ≥80 years) with nonvalvular atrial fibrillation (AF) who were not candidates for oral anticoagulant therapy at doses approved for stroke prevention. The primary efficacy endpoint was the composite of stroke or systemic embolism. A total of 984 patients were randomly assigned in a 1:1 ratio to receive a daily dose of 15 mg of E (n = 492) or placebo (n = 492). The annualized rate of stroke or systemic embolism was 2.3% in the E group and 6.7% in the placebo group (hazard ratio [HR] 0.34; P <.001), and the annualized rate of major bleeding was 3.3% in the E group and 1.8% in the placebo group (HR 1.87; P = .09). The authors conclude that in very elderly patients with nonvalvular AF who were not appropriate candidates for standard doses of oral anticoagulants, a once-daily, 15-mg dose of E was superior to placebo in preventing stroke or systemic embolism and did not result in a significantly higher incidence of major bleeding than placebo.
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