CLINICAL RESEARCH: ARRHYTHMIAS
Analysis of mortality events in the multicenter automatic defibrillator implantation trial (MADIT-II)
Henry Greenberg, MD* ,*,
Robert B. Case, MD*,
Arthur J. Moss, MD ,
Mary W. Brown, MS,
Elizabeth R. Carroll, MA,
Mark L. Andrews, BBS MADIT-II Investigators
* Cardiology Division of the Department of Medicine, St. Luke's Roosevelt Hospital Center and Columbia University College of Physicians and Surgeons, New York, New York, USA
Cardiology Unit, Department of Medicine, University of Rochester Medical Center, Rochester, New York, USA
Members of the MADIT-II End Point Review Committee, chaired by Dr. Henry Greenberg, USA
Manuscript received July 8, 2003;
revised manuscript received November 7, 2003,
accepted November 13, 2003.
* Reprint requests and correspondence: Dr. Henry Greenberg, Division of Cardiology, St. Luke's Roosevelt Hospital Center, 1000 10th Avenue, Room 3B-30, New York, New York 10019, USA.
hgreenberg{at}chpnet.org
OBJECTIVES: The purpose of this study was to determine the efficacy of implantable cardiac defibrillator (ICD) therapy in preventing sudden cardiac death (SCD) in post-infarction patients with advanced left ventricular (LV) dysfunction.
BACKGROUND: The Multicenter Automatic Defibrillator Implantation Trial (MADIT-II) randomized 1,232 post-infarction patients with an ejection fraction of  30% to ICD or conventional therapy. In the ICD group, there was a 31% decrease in the risk of total mortality. However, a better understanding of the mode of death is desirable in order to refine therapeutic interventions in high-risk populations.
METHODS: We evaluated the 202 deaths, using a variation of the Hinkle-Thaler classification system as well as a clinical classification system to determine the incidence of SCD and the incidence of cardiac death due to progressive LV failure.
RESULTS: The SCD rates were 10.0% in the conventional group and 3.8% in the ICD group (p < 0.01). The hazard ratio for the risk of SCD in the ICD group compared with the conventional therapy group was 0.33 (95% confidence interval 0.20 to 0.53, p < 0.0001). The ICD had no meaningful effect on non-sudden death (p = 0.32). The effect of defibrillator therapy in reducing SCD was similar in subgroup analyses stratified according to relevant baseline characteristics.
CONCLUSIONS: The decrease in mortality with ICD therapy in MADIT-II is entirely due to a reduction in SCD, with similar reductions in SCD in a spectrum of subgroups stratified according to relevant baseline characteristics.
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Abbreviations and Acronyms
| | ECG | = electrocardiographic | | EF | = ejection fraction | | HF | = heart failure | | HR | = hazard ratio | | ICD | = implantable cardiac defibrillator | | LV | = left ventricular | | MADIT-II | = Multicenter Automatic Defibrillator Implantation Trial | | MI | = myocardial infarction | | NYHA | = New York Heart Association | | SCD | = sudden cardiac death |
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