Apixaban compared to heparin/Vitamin K antagonist in patients with atrial fibrillation scheduled for cardioversion: The EMANATE trial

Michael D. Ezekowitz, Charles V. Pollack, Jonathan L. Halperin, Richard D. England, Sandra Van Pelt Nguyen, Judith Spahr, Maria Sudworth, Nilo B. Cater, Andrei Breazna, Jonas Oldgren, Paulus Kirchhof

Research output: Contribution to journalArticlepeer-review

125 Scopus citations

Abstract

Aim: The primary objective was to compare apixaban to heparin/vitamin K antagonist (VKA) in patients with atrial fibrillation (AF) and <_48 h anticoagulation prior to randomization undergoing cardioversion. .Methods: One thousand five hundred patients were randomized. The apixaban dose of 5 mg b.i.d. was reduced to 2.5 mg b.i.d. in patients with two of the following: age >_ 80 years, weight <_ 60 kg, or serum creatinine >_ 133 mmol/L. To expedite cardioversion, at the discretion of the investigator, imaging and/or a loading dose of 10 mg (down-titrated to 5 mg) was allowed. The endpoints for efficacy were stroke, systemic embolism (SE), and death. The endpoints for safety were major bleeding and clinically relevant non-major (CRNM) bleeding. .Results: There were 1038 active and 300 spontaneous cardioversions; 162 patients were not cardioverted. Imaging was performed in 855 patients, and 342 received a loading dose of apixaban. Comparing apixaban to heparin/VKA in the full analysis set, there were 0/753 vs. 6/747 strokes [relative risk (RR) 0; 95% confidence interval (95% CI) 0-0.64; nominal P = 0.015], no SE, and 2 vs. 1 deaths (RR 1.98; 95% CI 0.19-54.00; nominal P > 0.999). In the safety population, there were 3/735 vs. 6/721 major (RR 0.49; 95% CI 0.10-2.07; nominal P = 0.338) and 11 vs. 13 CRNM bleeding events (RR 0.83; 95% CI 0.34-1.89; nominal P = 0.685). On imaging, 60/61 with thrombi continued randomized treatment; all (61) were without outcome events. Conclusion: Rates of strokes, systemic emboli, deaths, and bleeds were low for both apixaban and heparin/VKA treated AF patients undergoing cardioversion.

Original languageEnglish
Pages (from-to)2959-2971
Number of pages13
JournalEuropean Heart Journal
Volume39
Issue number32
DOIs
StatePublished - 1 Aug 2018

Keywords

  • Anticoagulation
  • Apixaban
  • Atrial fibrillation
  • Cardiac imaging
  • Cardioversion
  • Heparin/Vitamin K antagonist
  • Stroke

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