Author + information
- Received August 25, 2015
- Revision received September 30, 2015
- Accepted October 7, 2015
- Published online April 1, 2016.
- Konstantinos C. Siontis, MDa,
- John P.A. Ioannidis, MD, DScb,c,d,e,
- George D. Katritsis, MB, ChB, BScf,
- Peter A. Noseworthy, MDg,
- Douglas L. Packer, MDg,
- John D. Hummel, MDh,
- Pierre Jais, MD, PhDi,
- Rungroj Krittayaphong, MDj,
- Llius Mont, MD, PhDk,
- Carlos A. Morillo, MDl,
- Jens Cosedis Nielsen, MDm,
- Hakan Oral, MDn,
- Carlo Pappone, MD, PhDo,
- Vincenzo Santinelli, MDo,
- Rukshen Weerasooriya, MBBSp,
- David J. Wilber, MDq,
- Bernard J. Gersh, MB, ChB, DPhilg,
- Mark E. Josephson, MDr and
- Demosthenes G. Katritsis, MD, PhDr,∗ ()
- aDepartment of Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota
- bDepartment of Medicine, Stanford University School of Medicine, Stanford, California
- cDepartment of Health Research and Policy, Stanford University School of Medicine, Stanford, California
- dDepartment of Statistics, Stanford University School of Humanities and Sciences, Stanford, California
- eMeta-Research Innovation Center at Stanford (METRICS), Stanford, California
- fOxford University Clinical Academic Graduate School, Radcliffe Hospital, Oxford, United Kingdom
- gDivision of Cardiovascular Diseases, Mayo Clinic College of Medicine, Rochester, Minnesota
- hDivision of Cardiology, Ohio State University Wexner Medical Center, Ohio State University, Columbus, Ohio
- iHôpital Cardiologique du Haut-L'évêque, l'Université Victor Segalen Bordeaux II, Institut LYRIC, Bordeaux, France
- jDivision of Cardiology, Siriraj Hospital, Mahidol University, Bangkok, Thailand
- kThorax Institute (ICT), Cardiology Department, Hospital Clinic, University of Barcelona, Barcelona, Spain
- lCardiology Division, Department of Medicine, Arrhythmia Service, Hamilton Health Sciences, McMaster University, Population Health Research Institute, Hamilton, Ontario, Canada
- mDepartment of Cardiology, Aarhus University Hospital, Aarhus, Denmark
- nDivision of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan
- oDepartment of Arrhythmology, IRCCS Policlinico San Donato, San Donato Milanese, Milano, Italy
- pUniversity of Western Australia, Crawley, Australia
- qDivision of Cardiology, Department of Medicine, Loyola University Medical Center, Maywood, Illinois
- rBeth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
- ↵∗Reprint requests and correspondence:
Dr. Demosthenes G. Katritsis, Beth Israel Deaconess Medical Center, Division of Cardiology, 185 Pilgrim Road, Baker 4, Boston, Massachusetts 02215.
Objectives The aim of this study was to perform a collaborative meta-analysis of published and unpublished quality-of-life, morbidity, and mortality data from randomized controlled trial comparisons of radiofrequency ablation (RFA) and antiarrhythmic drug therapy (AAD) in symptomatic atrial fibrillation.
Background RFA is superior to AAD in decreasing recurrences of atrial fibrillation, but the effects on other clinical outcomes are not well established.
Methods The primary investigators of eligible randomized controlled trials were invited to contribute standardized outcome data. Random-effects summary estimates were calculated as standardized mean differences and risk ratios with 95% confidence intervals for continuous and binary outcomes, respectively. Fixed effects were used in subgroup analyses.
Results Twelve randomized controlled trials (n = 1,707 patients) were included. RFA led to greater improvements in 4 36-Item Short Form Health Survey areas and the symptom frequency score from baseline to 3 months. In all quality-of-life metrics, there was a trend toward diminution of the differences between the 2 approaches with follow-up. There were 7 of 866 (5 in a study using phased RFA) and 0 of 704 strokes in the RFA and AAD arms, respectively (p = 0.02, Fisher exact test). Bleeding and mortality events were not significantly different between the 2 arms. There was high heterogeneity for hospitalizations, with decreased hospitalization risk with RFA when it was not first-line therapy (risk ratio: 0.34; 95% confidence interval: 0.24 to 0.46) and increased risk as first-line therapy (risk ratio: 1.22; 95% confidence interval: 1.03 to 1.45).
Conclusions RFA demonstrates an early but nonsustained superiority over AAD for the improvement of quality of life. There are no obvious differences in other clinical outcomes, and the periprocedural stroke risk is non-negligible.
The MANTRA-PAF trial was supported by The Danish Heart Foundation and Biosense Webster. Dr. Nielsen has received speaking fees from Biotronik and Biosense Webster; and consulting fees from Boston Scientific. Dr. Hummel is a consultant for Medtronic and Biosense Webster. Dr. Krittayaphong has received honoraria and been on the advisory boards of Bayer and Boehringer Ingelheim. Dr. Mont has received research grants and honoraria for consulting and lectures from Medtronic, Biosense Webster, Boston Scientific, and St. Jude Medical. Dr. Pappone has financial relationships with St. Jude Medical and Biotronik. Dr. Gersh is a consultant for Medtronic and Boston Scientific. Dr. D.G. Katritsis has received research grants from Medtronic and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Eric Prystowsky, MD, served as Guest Editor for this paper.
- Received August 25, 2015.
- Revision received September 30, 2015.
- Accepted October 7, 2015.
- 2016 American College of Cardiology Foundation