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CC BY-NC-ND 4.0 · Thromb Haemost 2021; 121(04): 518-528
DOI: 10.1055/s-0040-1717115
Stroke, Systemic or Venous Thromboembolism

Long-Term Treatment with Apixaban in Patients with Atrial Fibrillation: Outcomes during the Open-Label Extension following AVERROES

Alexander P. Benz 
1   Population Health Research Institute, Hamilton, Ontario, Canada
,
John W. Eikelboom
1   Population Health Research Institute, Hamilton, Ontario, Canada
,
Salim Yusuf
1   Population Health Research Institute, Hamilton, Ontario, Canada
,
Stefan H. Hohnloser
2   Division Clinical Electrophysiology, Department of Cardiology, Johann Wolfgang Goethe University, Frankfurt, Germany
,
Anja Kahl
3   Bristol-Myers Squibb, Lawrenceville, New Jersey, Unites States
,
Heather Beresh
1   Population Health Research Institute, Hamilton, Ontario, Canada
,
Kumar Balasubramanian
1   Population Health Research Institute, Hamilton, Ontario, Canada
,
Jeff S. Healey
1   Population Health Research Institute, Hamilton, Ontario, Canada
,
Stuart J. Connolly
1   Population Health Research Institute, Hamilton, Ontario, Canada
› Author Affiliations Funding AVERROES and its open-label extension were funded by Bristol-Myers Squibb and Pfizer. A.P.B. reports a personal research grant from the German Heart Foundation (Deutsche Herzstiftung e.V.).
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Abstract

Background AVERROES, a randomized controlled trial in high-risk patients with atrial fibrillation, unsuitable for vitamin K antagonist therapy, demonstrated efficacy and safety of apixaban compared with aspirin. At the conclusion of the double-blind phase, an open-label extension was initiated to allow study participants to receive apixaban until it became locally available. This study reports outcomes of patients on apixaban during the open-label extension.

Methods Rates of stroke or systemic embolism, hemorrhagic stroke, major bleeding, and other outcomes during the open-label extension are reported.

Results Of the 5,599 participants enrolled in AVERROES, 3,275 (58.5%) received apixaban during the open-label extension. Median (interquartile range) follow-up in the open-label extension was 3.0 (2.5–3.5) years. The rate of stroke or systemic embolism during the open-label extension was 1.0% per year, and the annual rates of hemorrhagic stroke and major bleeding were 0.3 and 1.2%, respectively. After adjustment for imbalances in patient variables, event rates in patients on apixaban during the open-label extension were similar to those of patients receiving apixaban during AVERROES. Additional analyses in all patients who received apixaban, at any time from the start of AVERROES to the end of the open-label extension, were performed. This cohort (n = 4,414) showed annual event rates of 1.1% for stroke or systemic embolism, 0.3% for hemorrhagic stroke, and 1.2% for major bleeding.

Conclusion During the open-label extension, annual rates of stroke or systemic embolism, hemorrhagic stroke, and major bleeding remained as low as those observed during apixaban treatment in AVERROES. These data support the long-term efficacy and safety of apixaban in patients with atrial fibrillation.

Keywords

apixaban - extension - atrial fibrillation - stroke - bleeding

Supplementary Material



Publication History

Received: 20 February 2020

Accepted: 18 August 2020

Article published online:
04 October 2020

© 2020. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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Comment to this article:

Long-Term Effects of Apixaban Confirmed in the Open-Label Extension of AVERROES TrialThromb Haemost 2021; 121(04): 405-407
DOI: 10.1055/a-1367-0184

 

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