CLINICAL RESEARCH: HEART RHYTHM DISORDERS
Time Dependence of Defibrillator Benefit After Coronary Revascularization in the Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II
Ilan Goldenberg, MD*,*,
Arthur J. Moss, MD*,
Scott McNitt, MS*,
Wojciech Zareba, MD, PhD*,
W. Jackson Hall, PhD ,
Mark L. Andrews, BBS*,
David J. Wilber, MD ,
Helmut U. Klein, MD for the MADIT-II Investigators
* Cardiology Unit, Department of Medicine, University of Rochester Medical Center, Rochester, New York
Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York
Cardiovascular Institute, Loyola University Medical Center, Maywood, Illinois
Division of Cardiology, University Hospital, Magdeburg, Germany
Manuscript received September 6, 2005;
revised manuscript received December 5, 2005,
accepted December 13, 2005.
* Reprint requests and correspondence: Dr. Ilan Goldenberg, Heart Research Follow-Up Program, Box 653, University of Rochester Medical Center, Rochester, New York 14642 (Email: ilan.goldenberg{at}heart.rochester.edu).
OBJECTIVES: The study was designed to assess the effect of elapsed time from coronary revascularization (CR) on the benefit of the implantable cardioverter-defibrillator (ICD) and the risk of sudden cardiac death (SCD) in patients with ischemic left ventricular dysfunction.
BACKGROUND: The ICD improves survival in appropriately selected high-risk cardiac patients by 30% to 54%. However, in the Coronary Artery Bypass Graft (CABG)-Patch trial no evidence of improved survival was shown among a similar population of patients in whom an ICD was implanted prophylactically at the time of elective CABG.
METHODS: The outcome by time from CR was analyzed in 951 patients in whom a revascularization procedure was performed before enrollment in the Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II.
RESULTS: The adjusted hazard ratio (HR) of ICD versus conventional therapy was 0.64 (p = 0.01) among patients enrolled more than six months after CR, whereas no survival benefit with ICD therapy was shown among patients enrolled six months or earlier after CR (HR = 1.19; p = 0.76). In the conventional therapy group, the risk of cardiac death increased significantly with increasing time from CR (p for trend = 0.009), corresponding mainly to a six-fold increase in the risk of SCD among patients enrolled more than six months after CR.
CONCLUSIONS: In patients with ischemic left ventricular dysfunction, the efficacy of ICD therapy after CR is time dependent, with a significant life-saving benefit in patients receiving device implantation more than six months after CR. The lack of ICD benefit when implanted early after CR may be related to a relatively low risk of SCD during this time period.
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Abbreviations and Acronyms
| | CABG = coronary artery bypass graft | | CHD = coronary heart disease | | CR = coronary revascularization | | ICD = implantable cardioverter-defibrillator | | MADIT = Multicenter Automatic Defibrillator Implantation Trial | | PCI = percutaneous coronary intervention | | SCD = sudden cardiac death |
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