Cited by 6,552Cardiac pacing and defibrillation studiesHeart Failure Treatment and ManagementCardiac Health and Mental Health

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Amiodarone or an Implantable Cardioverter–Defibrillator for Congestive Heart Failure

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Bardy, Gust H., Lee, Kerry L., Mark, Daniel B., Poole, Jeanne E., Packer, Douglas L., Boineau, Robin, Domanski, Michael, Troutman, Charles, Anderson, Jill, Johnson, George, McNulty, Steven E., Clapp-Channing, Nancy, Davidson-Ray, Linda D., Fraulo, Elizabeth S., Fishbein, Daniel P., Luceri, Richard M., Ip, John H.·2005·New England Journal of Medicine

DOI 10.1056/nejmoa043399

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Abstract

BACKGROUND: Sudden death from cardiac causes remains a leading cause of death among patients with congestive heart failure (CHF). Treatment with amiodarone or an implantable cardioverter-defibrillator (ICD) has been proposed to improve the prognosis in such patients. METHODS: We randomly assigned 2521 patients with New York Heart Association (NYHA) class II or III CHF and a left ventricular ejection fraction (LVEF) of 35 percent or less to conventional therapy for CHF plus placebo (847 patients), conventional therapy plus amiodarone (845 patients), or conventional therapy plus a conservatively programmed, shock-only, single-lead ICD (829 patients). Placebo and amiodarone were administered in a double-blind fashion. The primary end point was death from any cause. RESULTS: The median LVEF in patients was 25 percent; 70 percent were in NYHA class II, and 30 percent were in class III CHF. The cause of CHF was ischemic in 52 percent and nonischemic in 48 percent. The median follow-up was 45.5 months. There were 244 deaths (29 percent) in the placebo group, 240 (28 percent) in the amiodarone group, and 182 (22 percent) in the ICD group. As compared with placebo, amiodarone was associated with a similar risk of death (hazard ratio, 1.06; 97.5 percent confidence interval, 0.86 to 1.30; P=0.53) and ICD therapy was associated with a decreased risk of death of 23 percent (0.77; 97.5 percent confidence interval, 0.62 to 0.96; P=0.007) and an absolute decrease in mortality of 7.2 percentage points after five years in the overall population. Results did not vary according to either ischemic or nonischemic causes of CHF, but they did vary according to the NYHA class. CONCLUSIONS: In patients with NYHA class II or III CHF and LVEF of 35 percent or less, amiodarone has no favorable effect on survival, whereas single-lead, shock-only ICD therapy reduces overall mortality by 23 percent.

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Authors: Bardy, G. H., Lee, K. L., Mark, D. B., Poole, J. E., Packer, D. L., Boineau, R., Domanski, M., Troutman, C., Anderson, J., Johnson, G., McNulty, S. E., Clapp-Channing, N., Davidson-Ray, L. D., Fraulo, E. S., Fishbein, D. P., Luceri, R. M., & Ip, J. H.
Affiliations: The Seattle Institute for Cardiac Research (US)
Duke University (US)
University of Washington (US)
Mayo Clinic (US)
National Heart, Lung, and Blood Institute (US)
ORCID: Lee, Kerry L.
Mark, Daniel B.
Poole, Jeanne E.
Packer, Douglas L.
Boineau, Robin
Davidson-Ray, Linda D.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2005-01-20
Volume: 352
Issue: 3
Pages: 225-237
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa043399
OpenAlex: W2075175982
Semantic Scholar: cf04075b17dbae3fc6bc9a3a2f9673f9fad192ea
Cited by: 6,552
References: 20
Citations by year: 2026: 126 · 2025: 170 · 2024: 173 · 2023: 186 · 2022: 231 · 2021: 236 · 2020: 261 · 2019: 285 · 2018: 287 · 2017: 394 · 2016: 326 · 2015: 355 · 2014: 335 · 2013: 369 · 2012: 376
FWCI: 292.60
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Funders: National Heart, Lung, and Blood Institute (UO1 HL55297, UO1 HL55496, UO1 HL55766, U01HL055297, U01HL055766, U01HL055496)
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Health and Mental Health
Keywords: amiodarone, implantable cardioverter-defibrillator, congestive heart failure, sudden cardiac death, mortality, left ventricular ejection fraction, NYHA functional class, antiarrhythmic therapy
MeSH terms: Aged, Amiodarone, Anti-Arrhythmia Agents, Cause of Death, Female, Heart Failure, Humans, Male, Middle Aged, Risk, Stroke Volume, Survival Analysis, Death, Sudden, Cardiac, Defibrillators, Implantable, Cross-Over Studies

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Amiodarone or an Implantable Cardioverter–Defibrillator for Congestive Heart Failure

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