Author + information
- Received June 6, 2016
- Revision received October 7, 2016
- Accepted October 20, 2016
- Published online January 2, 2017.
- Julia Seeger, MD,
- Birgid Gonska, MD,
- Christoph Rodewald, MD,
- Wolfgang Rottbauer, MD and
- Jochen Wöhrle, MD∗ ()
- ↵∗Reprint requests and correspondence:
Prof. Dr. Jochen Wöhrle, University of Ulm, Department of Internal Medicine II, Albert-Einstein-Allee 23, 89081 Ulm, Germany.
Objectives The aims of this study were to assess the impact of atrial fibrillation (AF) on outcome in transfemoral aortic valve replacement (TAVR) and to evaluate the safety and efficacy of apixaban compared with a vitamin K antagonist (VKA) in patients with AF after TAVR.
Background Non-VKA oral anticoagulant agents have not been systematically used in patients with AF after TAVR.
Methods Of the 617 patients enrolled, 55.9% (n = 345) were in sinus rhythm and 44.1% (n = 272) in AF. Clinical follow-up was performed after 30 days and 12 months.
Results The early safety endpoint at 30 days was significantly more frequent in patients with AF compared with those in sinus rhythm (23.2% vs. 11.0%; p < 0.01). During 12-month follow-up, the secondary endpoint of all-cause mortality and stroke was significantly higher in patients with AF (20.6% vs. 9.7%; p = 0.02), driven by a significantly higher rate of all-cause mortality (19.1% vs. 7.8%; p = 0.01). Among patients with AF, 141 (51.8%) were treated with apixaban and 131 (48.2%) with a VKA. There was a significantly lower rate of the early safety endpoint in patients with AF treated with apixaban compared with patients treated with a VKA (13.5% vs. 30.5%; p < 0.01), with a numerically lower stroke rate (2.1% vs. 5.3%; p = 0.17) at 30 days and 12 months (1.2% vs. 2.0%; p = 0.73) of follow-up.
Conclusions In patients undergoing TAVR, AF was associated with a significantly higher rate of all-cause mortality throughout 12 months follow-up. The early safety endpoint in patients with AF on apixaban was significantly less frequent compared with patients receiving a VKA.
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received June 6, 2016.
- Revision received October 7, 2016.
- Accepted October 20, 2016.
- American College of Cardiology Foundation