Cited by 2,489Cardiac electrophysiology and arrhythmiasCardiac pacing and defibrillation studiesCardiac Arrhythmias and Treatments

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A Randomized Study of the Prevention of Sudden Death in Patients with Coronary Artery Disease

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Buxton, Alfred E., Lee, Kerry L., Fisher, John D., Josephson, Mark E., Prystowsky, Eric N., Hafley, Gail·1999·New England Journal of Medicine

DOI 10.1056/nejm199912163412503

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Abstract

BACKGROUND: Empirical antiarrhythmic therapy has not reduced mortality among patients with coronary artery disease and asymptomatic ventricular arrhythmias. Previous studies have suggested that antiarrhythmic therapy guided by electrophysiologic testing might reduce the risk of sudden death. METHODS: We conducted a randomized, controlled trial to test the hypothesis that electrophysiologically guided antiarrhythmic therapy would reduce the risk of sudden death among patients with coronary artery disease, a left ventricular ejection fraction of 40 percent or less, and asymptomatic, unsustained ventricular tachycardia. Patients in whom sustained ventricular tachyarrhythmias were induced by programmed stimulation were randomly assigned to receive either antiarrhythmic therapy, including drugs and implantable defibrillators, as indicated by the results of electrophysiologic testing, or no antiarrhythmic therapy. Angiotensin-converting-enzyme inhibitors and beta-adrenergic-blocking agents were administered if the patients could tolerate them. RESULTS: A total of 704 patients with inducible, sustained ventricular tachyarrhythmias were randomly assigned to treatment groups. Five-year Kaplan-Meier estimates of the incidence of the primary end point of cardiac arrest or death from arrhythmia were 25 percent among those receiving electrophysiologically guided therapy and 32 percent among the patients assigned to no antiarrhythmic therapy (relative risk, 0.73; 95 percent confidence interval, 0.53 to 0.99), representing a reduction in risk of 27 percent). The five-year estimates of overall mortality were 42 percent and 48 percent, respectively (relative risk, 0.80; 95 percent confidence interval, 0.64 to 1.01). The risk of cardiac arrest or death from arrhythmia among the patients who received treatment with defibrillators was significantly lower than that among the patients discharged without receiving defibrillator treatment (relative risk, 0.24; 95 percent confidence interval, 0.13 to 0.45; P<0.001). Neither the rate of cardiac arrest or death from arrhythmia nor the overall mortality rate was lower among the patients assigned to electrophysiologically guided therapy and treated with antiarrhythmic drugs than among the patients assigned to no antiarrhythmic therapy. CONCLUSIONS: Electrophysiologically guided antiarrhythmic therapy with implantable defibrillators, but not with antiarrhythmic drugs, reduces the risk of sudden death in high-risk patients with coronary disease.

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“However, only a small number of women received ICDs in these clinical trials, ranging from b20 each in the Multicenter Unsustained Tachycardia Trial (MUSTT) and Multicenter Automatic Defibrillator Implantation Trial (MADIT) to 185 in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).(1,3,5) In contrast to the…”
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Increased left ventricular mass and decreased left ventricular systolic function have independent pathways to ventricular arrhythmogenesis in coronary artery disease
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“In addition, initial trials on SCD primary prevention included PES for risk stratification of high-risk patients with LVEF < 35–40%.(53,54) However, subsequent trials showed that the risk was already high enough in patients with LVEF < 30 or 35% to warrant ICD implantation without further PES stratification.”
Background
Rationale and design of a randomized controlled trial to assess the safety and efficacy of cardiac resynchronization therapy in patients with asymptomatic left ventricular dysfunction with previous symptoms or mild heart failure—the REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) study
Linde, C. M., Gold, M. R., Abraham, W. T., & Daubert, J. (2006) · American Heart Journal · doi:10.1016/j.ahj.2005.03.002 · Cited by 86
Disparities in the Use of Primary Prevention and Defibrillator Therapy Among Blacks and Women
Gauri, A. J., Davis, A. M., Hong, T. E., Burke, M. C., & Knight, B. P. (2006) · The American Journal of Medicine · doi:10.1016/j.amjmed.2005.08.021 · Cited by 83
Low heart rate variability is a risk factor for sudden cardiac death in type 2 diabetes
Kataoka, M., Ito, C., Sasaki, H., Yamane, K., & Kohno, N. (2003) · Diabetes Research and Clinical Practice · doi:10.1016/j.diabres.2003.10.009 · Cited by 85

Authors: Buxton, A. E., Lee, K. L., Fisher, J. D., Josephson, M. E., Prystowsky, E. N., & Hafley, G.
Affiliations: Brown University (US)
Duke University (US)
Albert Einstein College of Medicine (US)
Beth Israel Deaconess Medical Center (US)
ORCID: Buxton, Alfred E.
Lee, Kerry L.
Fisher, John D.
Prystowsky, Eric N.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 1999-12-16
Volume: 341
Issue: 25
Pages: 1882-1890
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejm199912163412503
OpenAlex: W2313547185
Cited by: 2,489
References: 34
Citations by year: 2026: 20 · 2025: 36 · 2024: 23 · 2023: 34 · 2022: 44 · 2021: 41 · 2020: 51 · 2019: 54 · 2018: 54 · 2017: 92 · 2016: 75 · 2015: 87 · 2014: 95 · 2013: 114 · 2012: 122
FWCI: 70.29
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Funders: National Institutes of Health (5u01hl045726-06)
National Heart, Lung, and Blood Institute (UO1HL45700, UO1-HL45726, U01HL045700)
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac electrophysiology and arrhythmias
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Arrhythmias and Treatments
Keywords: coronary artery disease, asymptomatic ventricular arrhythmia, implantable cardioverter-defibrillator, antiarrhythmic drugs, electrophysiologic testing, programmed electrical stimulation, cardiac arrest, all-cause mortality, left ventricular ejection fraction, ACE inhibitors, beta-blockers
MeSH terms: Aged, Anti-Arrhythmia Agents, Cardiac Pacing, Artificial, Coronary Disease, Electrophysiology, Female, Humans, Male, Middle Aged, Survival Analysis, Death, Sudden, Cardiac, Defibrillators, Implantable, Tachycardia, Ventricular

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A Randomized Study of the Prevention of Sudden Death in Patients with Coronary Artery Disease

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