Abstract 15761: Outcomes After Ablation And Cardioversion in Patients With Non-valvular Atrial Fibrillation: Results From the XANTUS Study
Introduction: Catheter ablation and cardioversion are standard care for re-establishing sinus rhythm in patients with non-valvular atrial fibrillation (AF) but carry a risk of periprocedural thromboembolic and bleeding events.
Methods: XANTUS was a non-interventional study of unselected non-valvular AF patients started on rivaroxaban. Patient data collected at ~3-month intervals included information on AF treatment procedures and all adverse events. The primary outcome was major bleeding (ISTH definition) with secondary outcomes of treatment-emergent adjudicated stroke, systemic embolism (SE) and death.
Results: Of the 6784 XANTUS patients, 502 underwent cardioversion and 173 ablation. Cardioversion patients were generally younger than those with no intervention (mean age 67.4 vs 71.8 years), with more newly diagnosed AF (32.1% vs 17.4%), fewer co-morbidities, lower CHA2DS2-VASc (2.7 vs 3.4) and lower HAS-BLED (1.7 vs 2.0) scores. A similar pattern was seen in ablation patients for age (64.1 vs 71.7 years), co-morbidities, CHA2DS2-VASc (2.4 vs 3.4) and HAS-BLED scores (1.6 vs 2.0), with more hospitalizations at baseline. In ablation patients, 30-day event rates for major bleeding were 2.9% (5/173), and the corresponding rate for ischemic stroke was 1.2% (2/173) with no SE or deaths. In cardioversion patients, the 42-day event rate for major bleeding was 0.6% (3/502), and the corresponding rate for ischemic stroke was 0.2% (1/502) with no SE or deaths. XANTUS showed low rates of adverse outcomes after cardioversion or ablation similar to those of the phase III X-VeRT and VENTURE AF studies (Table).
Conclusions: Prospective real-world data from XANTUS showed that outcome rates associated with cardioversion and ablation were low and similar to those of specialist-center-based phase III studies with rivaroxaban.
Author Disclosures: A. Camm: Research Grant; Modest; Bayer, BMS/Pfizer, Daiichi Sankyo, Boehringher Ingelheim. Honoraria; Modest; Bayer, BMS/Pfizer, Daiichi Sankyo, Boehringher Ingelheim. Consultant/Advisory Board; Modest; Bayer, BMS/Pfizer, Daiichi Sankyo, Boehringher Ingelheim. A. Turpie: Speakers Bureau; Modest; Janssen. Consultant/Advisory Board; Modest; Bayer Pharm. S. Hess: Employment; Modest; Bayer Healthcare. P. Amarenco: None. S. Kuhls: Employment; Modest; Bayer HealthCare Pharmaceuticals. S. Haas: Honoraria; Modest; Aspen, Bayer Healthcare, Bristol-Myers Squibb, Daiichi-Sankyo, Pfizer. Consultant/Advisory Board; Modest; Bayer Healthcare, Bristol-Myers Squibb, CSL-Behring, Daiichi-Sankyo, Sanofi. M. van Eickels: Employment; Modest; Bayer HealthCare Pharmaceuticals. P. Kirchhof: Consultant/Advisory Board; Modest; 3M Medica, MEDA Pharma, AstraZeneca, Bayer Healthcare, Biosense Webster, Boehringer Ingelheim, Daiichi Sankyo, German Cardiac Society, Medtronic, Merck, MSD, Otsuka Pharma, Pfizer/Bristol-Myers Squibb, Sanofi, Servier, Siemens, Takeda.
- © 2016 by American Heart Association, Inc.