Michalina Kołodziejczak, MD; Felicita Andreotti, MD, PhD; Mariusz Kowalewski, MD; Antonino Buffon, MD; Marco Matteo Ciccone, MD; Gianfranco Parati, MD; Pietro Scicchitano, MD; Julia M. Umińska, MD; Stefano De Servi, MD; Kevin P. Bliden, MBA; Jacek Kubica, MD, PhD; Alessandro Bortone, MD, PhD; Filippo Crea, MD; Paul Gurbel, MD; Eliano P. Navarese, MD, PhD
Disclosures: Dr. Andreotti reports personal fees from Actelion, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb–Pfizer, Daiichi Sankyo, and the Menarini International Foundation outside the submitted work. Dr. Parati reports honoraria from Pfizer, Daiichi Sankyo, and the Menarini International Foundation outside the submitted work. Dr. Gurbel reports grants from Haemonetics, Duke Clinical Research Institute, National Institutes of Health, Merck, MedImmune, and Coramed and personal fees from AstraZeneca, Boehringer Ingelheim, Merck, Janssen, Bayer, and Medicure, outside the submitted work, and has been issued a patent for Platelet Function Testing. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-0120.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol: Available from Dr. Navarese (e-mail, firstname.lastname@example.org). Statistical code: See Methods. Data set: See tables, figures, and Supplement.
Requests for Single Reprints: Eliano P. Navarese, MD, PhD, Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, 3300 Gallows Road, Falls Church, VA 22042; e-mail, email@example.com.
Current Author Addresses: Dr. Kołodziejczak: Ludwik Rydygier Collegium Medicum, Nicolaus Copernicus University, Skłodowskiej-Curie Street No. 9, 85-094 Bydgoszcz, Poland.
Drs. Andreotti, Buffon, and Crea: Institute of Cardiology, Catholic University Medical School, Via Massimi 96, 00136 Rome, Italy.
Dr. Kowalewski: Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital, Skłodowskiej-Curie Street No. 9, 85-094 Bydgoszcz, Poland.
Drs. Ciccone, Scicchitano, and Bortone: Department of Emergency and Organ Transplantation, Section of Cardiovascular Diseases, School of Medicine, University of Bari, Piazza G. Cesare 11, 70124, Bari, Italy.
Dr. Parati: Department of Cardiovascular, Neural and Metabolic Sciences, S. Luca Hospital, IRCCS Istituto Auxologico Italiano, Piazzale Brescia, 20, 20149 Milan, Italy.
Drs. Umińska and Kubica: Department of Cardiology and Internal Medicine, Ludwik Rydygier Collegium Medicum, Nicolaus Copernicus University, Skłodowskiej-Curie Street No. 9, 85-094 Bydgoszcz, Poland.
Dr. De Servi: Department of Cardiology, Multimedica IRCCS, Via Milanese, 300, 20141 Milan, Italy.
Mr. Bliden and Drs. Gurbel and Navarese: Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, 3300 Gallows Road, Falls Church, VA 22042.
Author Contributions: Conception and design: M. Kołodziejczak, F. Andreotti, M.M. Ciccone, G. Parati, J. Kubica, P. Gurbel, E.P. Navarese.
Analysis and interpretation of the data: M. Kołodziejczak, F. Andreotti, M. Kowalewski, A. Buffon, M.M. Ciccone, G. Parati, P. Scicchitano, S. De Servi, E.P. Navarese.
Drafting of the article: M. Kołodziejczak, F. Andreotti, M. Kowalewski, A. Buffon, M.M. Ciccone, P. Scicchitano, K.P. Bliden, E.P. Navarese.
Critical revision for important intellectual content: M. Kołodziejczak, F. Andreotti, M. Kowalewski, A. Buffon, M.M. Ciccone, G. Parati, P. Scicchitano, J. Umińska, J. Kubica, A. Bortone, F. Crea, P. Gurbel, E.P. Navarese.
Final approval of the article: M. Kołodziejczak, F. Andreotti, M. Kowalewski, A. Buffon, M.M. Ciccone, G. Parati, P. Scicchitano, J. Umińska, S. De Servi, K.P. Bliden, J. Kubica, A. Bortone, F. Crea, P. Gurbel, E.P. Navarese.
Provision of study materials or patients: F. Andreotti, M.M. Ciccone; P. Schicchitano.
Statistical expertise: M. Kowalewski, E.P. Navarese.
Administrative, technical, or logistic support: K.P. Bliden.
Collection and assembly of data: M. Kołodziejczak, M. Kowalewski, M.M. Ciccone, P. Schicchitano.
Implantable cardioverter-defibrillators (ICDs) have a role in preventing cardiac arrest in patients at risk for life-threatening ventricular arrhythmias.
To compare ICD therapy with conventional care for the primary prevention of death of various causes in adults with ischemic or nonischemic cardiomyopathy.
MEDLINE, Cochrane Central Register of Controlled Trials, Google Scholar, and EMBASE databases, as well as several Web sites, from 1 April 1976 through 31 March 2017.
Randomized controlled trials, published in any language, comparing ICD therapy with conventional care and reporting mortality outcomes (all-cause, sudden, any cardiac, or noncardiac) in the primary prevention setting.
2 independent investigators extracted study data and assessed risk of bias.
Included were 11 trials involving 8716 patients: 4 (1781 patients) addressed nonischemic cardiomyopathy, 6 (4414 patients) ischemic cardiomyopathy, and 1 (2521 patients) both types of cardiomyopathy. Mean follow-up was 3.2 years. An overall reduction in all-cause mortality, from 28.26% with conventional care to 21.37% with ICD therapy (hazard ratio [HR], 0.81 [95% CI, 0.70 to 0.94]; P = 0.043), was found. The magnitude of reduction was similar in the cohorts with nonischemic (HR, 0.81 [CI, 0.72 to 0.91]) and ischemic (HR, 0.82 [CI, 0.63 to 1.06]) disease, although the latter estimate did not reach statistical significance. The rate of sudden death fell from 12.15% with conventional care to 4.39% with ICD therapy (HR, 0.41 [CI, 0.30 to 0.56]), with a similar magnitude of reduction in patients with ischemic (HR, 0.39 [CI, 0.23 to 0.68]) and those with nonischemic disease (HR, 0.44 [CI, 0.17 to 1.12]). Noncardiac and any cardiac deaths did not differ significantly by treatment.
Heterogeneous timing of ICD placement; heterogeneous pharmacologic and resynchronization co-interventions; trials conducted in different eras; adverse events and complications not reviewed.
Overall, primary prevention with ICD therapy versus conventional care reduced the incidence of sudden and all-cause death.
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Kołodziejczak M, Andreotti F, Kowalewski M, Buffon A, Ciccone MM, Parati G, et al. Implantable Cardioverter-Defibrillators for Primary Prevention in Patients With Ischemic or Nonischemic Cardiomyopathy: A Systematic Review and Meta-analysis. Ann Intern Med. 2017;167:103-111. doi: 10.7326/M17-0120
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Published: Ann Intern Med. 2017;167(2):103-111.
Published at www.annals.org on 27 June 2017
Cardiology, Prevention/Screening, Rhythm Disorders and Devices.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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