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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“We did not observe differences in mean age (66±10 years) or sex distribution (83% males) in comparison with all major trials [1–3,5,6,8].”
BackgroundMethodResultInfluential
Use of Implantable Cardioverter‐Defibrillator in Inherited Arrhythmogenic Diseases: Data from Italian ICD Registry for the Years 2001–6
Proclemer, A., Ghidina, M., Facchin, D., Rebellato, L., Corrado, D., Gasparini, M., & Gregori, D. (2009) · Pacing and Clinical Electrophysiology · doi:10.1111/j.1540-8159.2009.02302.x · Cited by 16
Implantable Cardioverter-Defibrillators Confer Survival Benefit in Patients with Chronic Obstructive Pulmonary Disease
Razak, E., Kamireddy, S., & Saba, S. (2010) · Pacing and Clinical Electrophysiology · doi:10.1111/j.1540-8159.2010.02786.x · Cited by 16
Mean frequency of premature ventricular complexes as predictor of malignant ventricular arrhythmias.
Carrim, Z. I., & Khan, A. A. (2005) · PubMed · Cited by 16
Microvolt T-wave alternans during exercise and pacing are not comparable
Kraaier, K., Verhorst, P. M. J., van der Palen, J. A. M., van Dessel, P. F. H. M., Wilde, A. A. M., & SCHOLTEN, M. F. (2009) · EP Europace · doi:10.1093/europace/eup253 · Cited by 16
Internal defibrillation with minimal skeletal muscle activation: A new paradigm toward painless defibrillation
Jayam, V., Zviman, M. M., Jayanti, V. B., Roguin, A., Halperin, H. R., & Berger, R. D. (2005) · Heart Rhythm · doi:10.1016/j.hrthm.2005.06.030 · Cited by 16
Ventricular arrhythmia storm in the era of implantable cardioverter-defibrillator
Looi, K., Tang, A., & Agarwal, S. (2015) · Postgraduate Medical Journal · doi:10.1136/postgradmedj-2015-133550 · Cited by 16
Ethical challenges in advanced heart failure
Kini, V., & Kirkpatrick, J. N. (2013) · Current Opinion in Supportive and Palliative Care · doi:10.1097/spc.0b013e32835c4915 · Cited by 16
Antiarrhythmic Drugs and Strategies
Opie, L. H., Dimarco, J., & Gersh, B. J. (2009) · Elsevier eBooks · doi:10.1016/b978-1-4160-6158-8.50013-7 · Cited by 16
Impact of implantable cardioverter defibrillators on survival and recurrent hospitalization in advanced heart failure
Nazarian, S., Maisel, W. H., Miles, J. S., Tsang, S. W., Stevenson, L. W., & Stevenson, W. G. (2005) · American Heart Journal · doi:10.1016/j.ahj.2005.01.012 · Cited by 16
Chronic Kidney Disease and Mortality in Implantable Cardioverter-Defibrillator Recipients
Cheema, A., Singh, T., Kanwar, M. K., Chilukuri, K., Maria, V., Saleem, F., Johnson, K. M., Frank, J. J., Pires, L. A., & Hassan, S. A. (2010) · Cardiology Research and Practice · doi:10.4061/2010/989261 · Cited by 16
“SAGE-Hindawi Access to Research Cardiology Research and Practice Volume 2010, Article ID 989261, 6 pages doi:10.4061/2010/989261”
MethodInfluential
Effectiveness of Implantable Cardioverter-Defibrillators in Patients With Ischemic Heart Disease and Left Ventricular Dysfunction
Chan, P. S. (2006) · Archives of Internal Medicine · doi:10.1001/archinte.166.20.2228 · Cited by 16
Variability in Implantable Cardioverter Defibrillator Pulse Generator Longevity Between Manufacturers
Ellinor, P. T., Guy, M. L., Ruskin, J. N., & McGovern, B. A. (2003) · Pacing and Clinical Electrophysiology · doi:10.1046/j.1460-9592.2003.00153.x · Cited by 16
Prevention and management of chronic heart failure with electrical therapy
Engelstein, E. D. (2003) · The American Journal of Cardiology · doi:10.1016/s0002-9149(02)03340-4 · Cited by 16
Fear of Exertion Following ICD Storm: Considering ICD Shock and Learning History
Sears, S. F., Rauch, S. A. M., Handberg, E. M., & CONTI, J. B. (2001) · Journal of Cardiopulmonary Rehabilitation · doi:10.1097/00008483-200101000-00009 · Cited by 16
The DATAS rationale and design: a controlled, randomized trial to assess the clinical benefit of dual chamber (DDED) defibrillator
Quesada, A., Almendral, J. M., Arribas, F., Ricci, R. P., Wolpert, C., Adragão, P., Cobo, E., & Navarro, X. (2004) · EP Europace · doi:10.1016/j.eupc.2003.11.011 · Cited by 16
Internal low-energy cardioversion: A therapeutic option for restoring sinus rhythm in chronic atrial fibrillation after failure of external cardioversion
Taramasco, V. (1999) · EP Europace · doi:10.1053/eupc.1999.0035 · Cited by 16
All Patients With Hemodynamically Tolerated Postinfarction Ventricular Tachycardia Do Not Require an Implantable Cardioverter-Defibrillator
Almendral, J. M., & Josephson, M. E. (2007) · Circulation · doi:10.1161/circulationaha.106.670067 · Cited by 16
Self-citation
Heart Failure and Cardiac Resynchronization Therapies: U.S. Experience in the Year 2000
Saxon, L. A., Kumar, U., & Marco, T. D. (2000) · Annals of Noninvasive Electrocardiology · doi:10.1111/j.1542-474x.2000.tb00385.x · Cited by 16
Sudden cardiac death after PCI and CABG in the bare-metal stent era: Incidence, prevalence, and predictors
Nishiyama, K., Shizuta, S., Doi, T., Morimoto, T., & Kimura, T. (2009) · International Journal of Cardiology · doi:10.1016/j.ijcard.2009.01.040 · Cited by 15
Questionnaire Survey of Cardiologists’ Knowledge, Attitudes, and Guideline Application of Implantable Cardioverter Defibrillator Therapy
Sadarmin, P. P., Wong, K. C., Rajappan, K., Bashir, Y., & Betts, T. R. (2012) · Pacing and Clinical Electrophysiology · doi:10.1111/j.1540-8159.2012.03373.x · Cited by 15
Do Physicians’ Attitudes toward Implantable Cardioverter Defibrillator Therapy Vary by Patient Age, Gender, or Race?
Al‐Khatib, S. M., Sanders, G. D., O’Brien, S. M., Matlock, D. D., Zimmer, L. O., Masoudi, F. A., & Peterson, E. D. (2011) · Annals of Noninvasive Electrocardiology · doi:10.1111/j.1542-474x.2010.00412.x · Cited by 15
Does defibrillation threshold increase as left ventricular ejection fraction decreases?
Val-Mejias, J. E., & OZA, A. L. (2010) · EP Europace · doi:10.1093/europace/eup408 · Cited by 15
Cardioverter-defibrillators: a cost or an investment?
Leyva, F., Lozano, I. F., & Morgan, J. M. (2011) · EP Europace · doi:10.1093/europace/eur085 · Cited by 15
Current Treatment Strategies for Heart Failure: Role of Device Therapy and LV Reconstruction
Janaswamy, P., Walters, T. E., Nazer, B., & Lee, R. J. (2016) · Current Treatment Options in Cardiovascular Medicine · doi:10.1007/s11936-016-0479-1 · Cited by 15
Trends in the use of implantable cardioverter‐defibrillators for prevention of sudden cardiac arrest: A South Korean nationwide population‐based study
Roh, S., Choi, J., Kim, M. S., Cho, E. Y., Kim, Y. G., Lee, K., Baek, Y., Shim, J., Kim, J. S., Park, S. W., et al. (2019) · Pacing and Clinical Electrophysiology · doi:10.1111/pace.13741 · Cited by 15
Self-citation
Sudden cardiac death in patients with myocardial infarction: 1.5 primary prevention
Feng, Y., & Feng, X. (2021) · Reviews in Cardiovascular Medicine · doi:10.31083/j.rcm2203087 · Cited by 16
Cost-Effectiveness of Implantable Cardioverter-Defibrillators in Brugada Syndrome Treatment
Wang, K., Yamauchi, K., Li, P., Kato, H., Kobayashi, M., Kato, K., & Shimizu, Y. (2007) · Journal of Medical Systems · doi:10.1007/s10916-007-9107-7 · Cited by 15
Implantable Cardiac Pulse Generators: Pacemakers and Cardioverter-Defibrillators
Rozner, M. A. (2010) · Elsevier eBooks · doi:10.1016/b978-0-443-06959-8.00043-1 · Cited by 15
Heart Rhythm Society/Pediatric and Congenital Electrophysiology Society Clinical Competency Statement: Training pathways for implantation of cardioverter-defibrillators and cardiac resynchronization therapy devices in pediatric and congenital heart patients
Saul, J. P., Epstein, A. E., Silka, M. J., Berul, C. I., Dick, M., Dimarco, J., Friedman, R. A., Rosenthal, É., Stephenson, E. A., & Vetter, V. L. (2008) · Heart Rhythm · doi:10.1016/j.hrthm.2008.04.012 · Cited by 15
Efficacy of Pharmacologic and Cardiac Implantable Electronic Device Therapies in Patients With Heart Failure and Reduced Ejection Fraction
Tseng, A. S., Kunze, K. L., Lee, J. Z., Amin, M., Neville, M. R., Almader‐Douglas, D., Killu, A. M., Madhavan, M., Cha, Y., Asirvatham, S. J., et al. (2019) · Circulation Arrhythmia and Electrophysiology · doi:10.1161/circep.118.006951 · Cited by 14
Treatment of Arrhythmias and Use of Implantable Cardioverter-Defibrillators to Improve Survival in Elderly Patients with Cardiac Disease
Goldenberg, I., & Moss, A. J. (2007) · Clinics in Geriatric Medicine · doi:10.1016/j.cger.2006.08.010 · Cited by 15
Antiarrhythmic drugs and strategies
Nattel, S., Gersh, B. J., & Opie, L. H. (2013) · Elsevier eBooks · doi:10.1016/b978-1-4557-3322-4.00017-x · Cited by 15
Evaluation and Management of Cardiac Arrhythmias in the Elderly
Tresch, D. D. (2001) · Medical Clinics of North America · doi:10.1016/s0025-7125(05)70325-4 · Cited by 15
Implantable defibrillators: from the adult cardiac to the grown up congenital heart disease patient
Gatzoulis, K. A., Frogoudaki, A., Brili, S. V., & Stefanadis, C. (2004) · International Journal of Cardiology · doi:10.1016/j.ijcard.2004.08.016 · Cited by 15
An Analysis of Implantable Cardiac Device Reliability. The Case for Improved Postmarketing Risk Assessment and Surveillance
Laskey, W. K., Awad, K., Lum, J. J., Skodacek, K., Zimmerman, B., Selzman, K. A., & Zuckerman, B. D. (2012) · American Journal of Therapeutics · doi:10.1097/mjt.0b013e3182512ca5 · Cited by 15
POSTOPERATIVE ARRHYTHMIAS AND CONDUCTION DISORDERS
Sloan, S. B., & Weitz, H. H. (2001) · Medical Clinics of North America · doi:10.1016/s0025-7125(05)70371-0 · Cited by 15
Efficacy of Anti-Tachycardia Pacing for Terminating Fast Ventricular Tachycardia in Japanese Implantable Cardioverter Defibrillator Patients
Watanabe, T., Inoue, K., Kashiwase, K., Mine, T., Hirooka, K., Shutta, R., Okuyama, Y., Mizuno, H., Shimoshige, S., Takenaka, S., et al. (2014) · Circulation Journal · doi:10.1253/circj.cj-14-0146 · Cited by 15
“4–6 The 5 main findings of the present study are that (1) the first ATP for terminating FVT in the present subject group with mixed etiology was effective; (2) the efficacy of the first ATP for FVT in the present subject group was similar to that previously identified in patients mostly with CAD; (3) the efficacy of t…”
Result

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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