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J Am Coll Cardiol. 2014 Mar 25;63(11):1082-7. doi: 10.1016/j.jacc.2013.09.062. Epub 2013 Nov 6.

Efficacy and safety of apixaban in patients after cardioversion for atrial fibrillation: insights from the ARISTOTLE Trial (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation).

Author information

1
Division of Cardiovascular Medicine, Department of Internal Medicine, University of Missouri, Columbia, Missouri. Electronic address: flakerg@missouri.edu.
2
Division of Cardiology, Department of Medicine, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.
3
Department of Electrocardiology, Instituto Nacional de Cardiologia, "Ignacio Chavez," Juan Badiano #1, Seccion XVI, Tlalpan, Mexico.
4
J.W. Goethe-University, Frankfurt, Germany.
5
Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.
6
Bristol-Myers Squibb, Princeton, New Jersey.
7
University of New Mexico, Albuquerque, New Mexico.
8
Cardiologisch Centrum, OLV Zienkenhuis, Aalst, Belgium.
9
University of Medicine and Pharmacy Carol Davila, Bucharest, Romania.
10
Department of Cardiology, Århus University Hospital, Århus, Denmark.
11
Division of Emergency Care, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland.
12
Department of Clinical Science and Education, Karolinska Institutet, Stockholm, Sweden.

Abstract

OBJECTIVES:

The aim of this study was to determine the risk of major clinical and thromboembolic events after cardioversion for atrial fibrillation in subjects treated with apixaban, an oral factor Xa inhibitor, compared with warfarin.

BACKGROUND:

In patients with atrial fibrillation, thromboembolic events may occur after cardioversion. This risk is lowered with vitamin K antagonists and dabigatran.

METHODS:

Using data from the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial, we conducted a post-hoc analysis of patients undergoing cardioversion.

RESULTS:

A total of 743 cardioversions were performed in 540 patients: 265 first cardioversions in patients assigned to apixaban and 275 in those assigned to warfarin. The mean time to the first cardioversion for patients assigned to warfarin and apixaban was 243 ± 231 days and 251 ± 248 days, respectively; 75% of the cardioversions occurred by 1 year. Baseline characteristics were similar between groups. In patients undergoing cardioversion, no stroke or systemic emboli occurred in the 30-day follow-up period. Myocardial infarction occurred in 1 patient (0.2%) receiving warfarin and 1 patient receiving apixaban (0.3%). Major bleeding occurred in 1 patient (0.2%) receiving warfarin and 1 patient receiving apixaban (0.3%). Death occurred in 2 patients (0.5%) receiving warfarin and 2 patients receiving apixaban (0.6%).

CONCLUSIONS:

Major cardiovascular events after cardioversion of atrial fibrillation are rare and comparable between warfarin and apixaban. (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation [ARISTOTLE]; NCT00412984).

KEYWORDS:

atrial fibrillation; cardioversion; factor Xa inhibitor; thromboembolic events; vitamin K antagonist

PMID:
24211508
DOI:
10.1016/j.jacc.2013.09.062
[Indexed for MEDLINE]
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