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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

View larger version (49K): [in a new window]   Figure 1 Distribution of sudden cardiac death (SCD), non-sudden cardiac death (NSCD), and unclassified cardiac deaths in the conventional and defibrillator therapy groups of MADIT-II, which randomized 490 patients to the conventional group and 742 patients to the defibrillator group. A total of 80 cardiac deaths occurred in the conventional group and 79 in the defibrillator group, with a cardiac death rate of 16.3% and 10.6%, respectively. The overall size of the two pie graphs is roughly proportional to the relative cardiac mortality rates in the two treatment groups. Sudden cardiac death makes up 61% of the cardiac deaths in the conventional therapy group and 35% in the defibrillator group, with reverse percentages for NSCD. The unlabeled solid-black area of each graph represents the percentage of unclassified cardiac deaths in each group.

View larger version (19K): [in a new window]   Figure 2 Kaplan-Meier estimates of the cumulative probability of sudden cardiac death (SCD) (A) and non-sudden cardiac death (B) in the groups assigned to receive an implantable cardioverter-defibrillator (ICD) or conventional medical therapy (CONV). For SCD, the overall difference in mortality between the two treatment groups was significant (nominal p < 0.0001), with two-year SCD rates of 4.9% and 12.1% in the ICD and CONV groups, respectively. For non-SCD, the overall difference in mortality between the two treatment groups was not significant (nominal p = 0.32), with two-year non-SCD rates of 7.0% and 4.6% in the ICD and CONV groups, respectively.