A Prospective Randomized Trial of Apixaban Dosing During Atrial Fibrillation Ablation The AEIOU Trial

被引:59
|
作者
Reynolds, Matthew R. [1 ,2 ]
Allison, J. Scott [3 ]
Natale, Andrea [4 ]
Weisberg, Ian L. [5 ]
Ellenbogen, Kenneth A. [6 ]
Richards, Mark [7 ]
Hsieh, Wen-Hua [8 ]
Sutherland, Julie [8 ]
Cannon, Christopher P. [2 ,8 ]
机构
[1] Lahey Hosp & Med Ctr, Burlington, MA USA
[2] Baim Inst Clin Res, 930 Commonwealth Ave, Boston, MA 02215 USA
[3] Heart Ctr Res, Huntsville, AL USA
[4] Texas Cardiac Arrhythmia Res Fdn, Austin, TX USA
[5] Baptist Heart & Vasc Inst, Pensacola, FL USA
[6] Virginia Commonwealth Univ, Richmond, VA USA
[7] ProMed Toledo Hosp, Toledo, OH USA
[8] Brigham & Womens Hosp, 75 Francis St, Boston, MA 02115 USA
关键词
anticoagulation; apixaban; atrial fibrillation; catheter ablation; clinical trial; warfarin; RADIOFREQUENCY CATHETER ABLATION; VITAMIN-K ANTAGONISTS; TRANSESOPHAGEAL ECHOCARDIOGRAPHY; ORAL ANTICOAGULANTS; THROMBUS PRIOR; WARFARIN; SAFETY; DABIGATRAN; EFFICACY; COMPLICATIONS;
D O I
10.1016/j.jacep.2017.11.005
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
OBJECTIVES This study sought to determine whether uninterrupted apixaban would have similar rates of bleeding and thromboembolic events as does minimally interrupted apixaban at the time of atrial fibrillation (AF) ablation and to compare those results with rates in historical patients treated with uninterrupted warfarin. BACKGROUND The safety, efficacy, and optimal dosing regimen for apixaban at the time of AF ablation are uncertain. METHODS This prospective, multicenter clinical trial enrolled 306 patients undergoing catheter ablation for nonvalvular AF and randomized 300 to uninterrupted versus minimally interrupted (holding 1 dose) periprocedural apixaban. A retrospective cohort of patients treated with uninterrupted warfarin at the same centers was matched to the apixaban-treated subjects for comparison. Endpoints included clinically significant bleeding, major bleeding, and nonhemorrhagic stroke or systemic embolism (SE) from the time of ablation through 30 days. RESULTS There were no stroke or SE events. Clinically significant bleeding occurred in 11.3% of 150 evaluable patients on uninterrupted apixaban and 9.7% of 145 evaluable patients on interrupted apixaban (risk difference: 1.7% [95% confidence interval: -5.5% to 8.8%]; p = NS). Rates of major bleeding were 1.3% with uninterrupted apixaban, and 2.1% with interrupted (risk difference: -0.7%; p = NS). The rates of clinically significant and major bleeding were similar for all apixaban patients combined (10.5% and 1.7%), compared with the matched warfarin group (9.8% and 1.4%). CONCLUSIONS Both uninterrupted and minimally interrupted apixaban at the time of AF ablation were associated with a very low rate of thromboembolic events, and rates of both major (<2%) and clinically significant bleeding were similar to uninterrupted warfarin. (C) 2018 by the American College of Cardiology Foundation.
引用
收藏
页码:580 / 588
页数:9
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