Author + information
- Received September 24, 2012
- Revision received February 14, 2013
- Accepted February 25, 2013
- Published online May 14, 2013.
- Jonathan P. Piccini, MD, MHS⁎,⁎ (, )
- Susanna R. Stevens, MS⁎,
- Yuliya Lokhnygina, PhD⁎,
- Manesh R. Patel, MD⁎,
- Jonathan L. Halperin, MD†,
- Daniel E. Singer, MD‡,
- Graeme J. Hankey, MD§,
- Werner Hacke, MD, PhD∥,
- Richard C. Becker, MD⁎,
- Christopher C. Nessel, MD¶,
- Kenneth W. Mahaffey, MD⁎,
- Keith A.A. Fox, MB, ChB#,
- Robert M. Califf, MD⁎⁎,
- Günter Breithardt, MD††,
- ROCKET AF Steering Committee & Investigators
- ↵⁎Reprint requests and correspondence:
Dr. Jonathan P. Piccini, Electrophysiology Section, Duke University Medical Center, Duke Clinical Research Institute, PO Box 17969, Durham, North Carolina 27710
Objectives This study sought to investigate the outcomes following cardioversion or catheter ablation in patients with atrial fibrillation (AF) treated with warfarin or rivaroxaban.
Background There are limited data on outcomes following cardioversion or catheter ablation in AF patients treated with factor Xa inhibitors.
Methods We compared the incidence of electrical cardioversion (ECV), pharmacologic cardioversion (PCV), or AF ablation and subsequent outcomes in patients in a post hoc analysis of the ROCKET AF (Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation) trial.
Results Over a median follow-up of 2.1 years, 143 patients underwent ECV, 142 underwent PCV, and 79 underwent catheter ablation. The overall incidence of ECV, PCV, or AF ablation was 1.45 per 100 patient-years (n = 321; 1.44 [n = 161] in the warfarin arm, 1.46 [n = 160] in the rivaroxaban arm). The crude rates of stroke and death increased in the first 30 days after cardioversion or ablation. After adjustment for baseline differences, the long-term incidence of stroke or systemic embolism (hazard ratio [HR]: 1.38; 95% confidence interval [CI]: 0.61 to 3.11), cardiovascular death (HR: 1.57; 95% CI: 0.69 to 3.55), and death from all causes (HR: 1.75; 95% CI: 0.90 to 3.42) were not different before and after cardioversion or AF ablation. Hospitalization increased after cardioversion or AF ablation (HR: 2.01; 95% CI: 1.51 to 2.68), but there was no evidence of a differential effect by randomized treatment (p value for interaction = 0.58). The incidence of stroke or systemic embolism (1.88% vs. 1.86%) and death (1.88% vs. 3.73%) were similar in the rivaroxaban-treated and warfarin-treated groups.
Conclusions Despite an increase in hospitalization, there were no differences in long-term stroke rates or survival following cardioversion or AF ablation. Outcomes were similar in patients treated with rivaroxaban or warfarin. (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation [ROCKET AF]; NCT00403767)
The ROCKET AF trial was sponsored by Johnson & Johnson Pharmaceutical Research and Development and Bayer HealthCare AG. Dr. Piccini has received research grants from Johnson & Johnson and is a consultant/advisory board member for Medtronic, Forest Laboratories, Sanofi Aventis, and Johnson & Johnson. Dr. Lokhnygina receives consulting fees from Johnson & Johnson and Bayer. Dr. Patel has received honoraria from Johnson & Johnson and Bayer; and consultancy fees from Ortho McNeil Janssen, Bayer HealthCare, and is an advisory board member with Genzyme. Dr. Singer is supported, in part, by the Eliot B. and Edith C. Shoolman fund of Massachusetts General Hospital; and has received consulting fees from Bayer HealthCare, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Johnson & Johnson, Pfizer, and Sanofi. Dr. Halperin has received honoraria from Johnson & Johnson and Bayer; and advisory fees from Boehringer-Ingelheim, Bristol Myers-Squibb, and Pfizer. Dr. Hankey has received honoraria from Johnson & Johnson, Bayer, and Sanofi-Aventis and is a member of the trial adjudication committee and advisory board for Boehringer-Ingelheim. Dr. Hacke has received honoraria from Johnson & Johnson and Bayer and advisory board fees from Boehringer-Ingelheim. Dr. Becker has received research support from Bayer and Johnson & Johnson. Dr. Nessel is an employee of Johnson & Johnson Mahaffey; received grant support from AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck, Momenta Pharmaceuticals, Novartis, Portola, Pozen, Regado Biotechnologies, Sanofi-Aventis, Schering-Plough (now Merck), and The Medicines Company; and has received consulting fees from AstraZeneca and Johnson & Johnson, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Ortho/McNeill, Pfizer, Polymedix, Sanofi-Aventis, and Schering-Plough (now Merck). Dr. Fox has received research grants and honoraria from Bayer, Lilly, Boehringer-Ingelheim, Sanofi-Aventis, and GlaxoSmithKline. Dr. Califf has received consulting fees and research funding from Johnson & Johnson and all other industry interactions are listed at the Duke Clinical Research Institute website. Dr. Breithardt has received honoraria from Johnson & Johnson and Bayer; and advisory board fees from Boehringer-Ingelheim, Bristol-Myers Squibb, Pfizer, and Sanofi-Aventis.
- Received September 24, 2012.
- Revision received February 14, 2013.
- Accepted February 25, 2013.
- American College of Cardiology Foundation