Author + information
- Received August 8, 2017
- Revision received October 25, 2017
- Accepted November 2, 2017
- Published online May 21, 2018.
- Matthew R. Reynolds, MD, MSca,b,∗ (, )
- J. Scott Allison, MDc,
- Andrea Natale, MDd,
- Ian L. Weisberg, MDe,
- Kenneth A. Ellenbogen, MDf,
- Mark Richards, MD, PhDg,
- Wen-Hua Hsieh, PhDb,
- Julie Sutherland, MDb and
- Christopher P. Cannon, MDb,h
- aLahey Hospital & Medical Center, Burlington, Massachusetts
- bBaim Institute for Clinical Research, Boston, Massachusetts
- cHeart Center Research, Huntsville, Alabama
- dTexas Cardiac Arrhythmia Research Foundation, Austin, Texas
- eBaptist Heart and Vascular Institute, Pensacola, Florida
- fVirginia Commonwealth University, Richmond, Virginia
- gProMedica Toledo Hospital, Toledo, Ohio
- hBrigham & Women’s Hospital, Boston, Massachusetts
- ↵∗Address for correspondence:
Dr. Matthew R. Reynolds, Baim Institute for Clinical Research, 930 Commonwealth Avenue, Boston, Massachusetts 02215.
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. (Apixaban Evaluation of Interrupted Or Uninterrupted Anticoagulation for Ablation of Atrial Fibrillation [AEIOU]; NCT02608099)
The AEIOU study was an investigator-initiated study sponsored by the Baim Institute for Clinical Research, with financial support from Bristol-Myers Squibb and Pfizer. Dr. Reynolds has served as a consultant for St. Jude Medical (Abbott), Medtronic, and Sanofi. Dr. Allison has served on the Speakers Bureau for Bristol-Myers Squibb and Pfizer. Dr. Weisberg has served as a speaker for Boehringer Ingelheim, Janssen, Bristol-Myers Squibb, Pfizer, and Biosense Webster. Dr. Richards has served on the Speakers Bureau for Medtronic, Boston Scientific, Biotronik, Pfizer, Boehringer Ingelheim, and Janssen; and has served on medical advisory boards for Boston Scientific, Biotronik, Janssen, and Cardialen. Dr. Cannon has served as a consultant for AstraZeneca Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Takeda; and has received research grant support from Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Janssen, and Takeda. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received August 8, 2017.
- Revision received October 25, 2017.
- Accepted November 2, 2017.
- 2018 American College of Cardiology Foundation
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