Author + information
- Received April 23, 2015
- Revision received September 25, 2015
- Accepted November 5, 2015
- Published online April 1, 2016.
- Amit Noheria, MBBS, SMa,
- Peter Shrader, MAb,
- Jonathan P. Piccini, MD, MHSb,
- Gregg C. Fonarow, MDc,
- Peter R. Kowey, MDd,
- Kenneth W. Mahaffey, MDe,
- Gerald Naccarelli, MDf,
- Peter A. Noseworthy, MDg,
- James A. Reiffel, MDh,
- Benjamin A. Steinberg, MD, MHSb,
- Laine E. Thomas, PhD, MPHb,
- Eric D. Peterson, MD, MPHb,
- Bernard J. Gersh, MBChB, DPhilg,∗ (, )
- ORBIT-AF Investigators and Patients
- aCardiovascular Division, Washington University, St. Louis, Missouri
- bDuke Clinical Research Unit, Durham, North Carolina
- cDepartment of Medicine, University of California Los Angeles, Los Angeles, California
- dLankenau Medical Center and Jefferson Medical College, Wynnewood, Pennsylvania
- eStanford Center for Clinical Research, Department of Medicine, Stanford University, Palo Alto, California
- fPenn State Heart and Vascular Institute, Hershey, Pennsylvania
- gDivision of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota
- hDivision of Cardiology, Columbia University, New York, New York
- ↵∗Reprint requests and correspondence:
Dr. Bernard J. Gersh, Mayo Clinic, 200 First Street Southwest, Rochester, Minnesota 55905.
Objectives The study sought to evaluate clinical outcomes in clinical practice with rhythm control versus rate control strategy for management of atrial fibrillation (AF).
Background Randomized trials have not demonstrated significant differences in stroke, heart failure, or mortality between rhythm and rate control strategies. The comparative outcomes in contemporary clinical practice are not well described.
Methods Patients managed with a rhythm control strategy targeting maintenance of sinus rhythm were retrospectively compared with a strategy of rate control alone in a AF registry across various U.S. practice settings. Unadjusted and adjusted (inverse-propensity weighted) outcomes were estimated.
Results The overall study population (N = 6,988) had a median of 74 (65 to 81) years of age, 56% were males, 77% had first detected or paroxysmal AF, and 68% had CHADS2 score ≥2. In unadjusted analyses, rhythm control was associated with lower all-cause death, cardiovascular death, first stroke/non–central nervous system systemic embolization/transient ischemic attack, or first major bleeding event (all p < 0.05); no difference in new onset heart failure (p = 0.28); and more frequent cardiovascular hospitalizations (p = 0.0006). There was no difference in the incidence of pacemaker, defibrillator, or cardiac resynchronization device implantations (p = 0.99). In adjusted analyses, there were no statistical differences in clinical outcomes between rhythm control and rate control treated patients (all p > 0.05); however, rhythm control was associated with more cardiovascular hospitalizations (hazard ratio: 1.24; 95% confidence interval: 1.10 to 1.39; p = 0.0003).
Conclusions Among patients with AF, rhythm control was not superior to rate control strategy for outcomes of stroke, heart failure, or mortality, but was associated with more cardiovascular hospitalizations.
The ORBIT-AF registry is sponsored by Janssen Scientific Affairs, LLC, Raritan, New Jersey. Dr. Piccini has received grants for clinical research from ARCA Biopharma, Boston Scientific, Johnson & Johnson, Gilead, St. Jude Medical, and ResMed; and has served as a consultant to Bristol-Myers Squibb, GlaxoSmithKline, Janssen Pharmaceuticals, Medtronic, and Spectranetics. Dr. Fonarow has served as a consultant to Janssen (modest) and Medtronic (significant). Dr. Kowey is a consultant for Johnson & Johnson. Dr. Mahaffey has received research grants from Amgen, Daiichi-Sankyo, Johnson & Johnson, Medtronic, St. Jude, and Tenax; has received consultant fees from the American College of Cardiology, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cubist, Eli Lilly, Elsevier, Epson, Forest, GlaxoSmithKline, Johnson & Johnson, Medtronic, Merck, Mt. Sinai, Myokardia, Orthera, Portola, Purdue Pharma, Spring Publishing, The Medicines Company, Vindico, and WebMD; and has equity in BioPrint Fitness. Dr. Naccarelli has served on the steering committee for Janssen, Biotechnology Inc., and Otsuka; as a consultant to Janssen, GlaxoSmithKline, Pfizer, Daiichi-Sankyo, Boehringer Ingelheim, Bristol-Myers Squibb, Sanofi, AstraZeneca, and Otsuka; and on the adjudications committee for GlaxoSmithKline. Dr. Steinberg has served as a consultant to Bristol-Myers Squibb. Dr. Peterson has served as a consultant for Janssen, AstraZeneca, Bayer, Merck, and Boehringer Ingelheim. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 23, 2015.
- Revision received September 25, 2015.
- Accepted November 5, 2015.
- 2016 American College of Cardiology Foundation