Long-term benefit of primary prevention with an implantable cardioverter-defibrillator: An extended 8-year follow-up study of the multicenter automatic defibrillator implantation trial II

Ilan Goldenberg, John Gillespie, Arthur J. Moss, W. Jackson Hall, Helmut Klein, Scott McNitt, Mary W. Brown, Iwona Cygankiewicz, Wojciech Zareba

Research output: Contribution to journalArticlepeer-review

Abstract

Background-: The Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II) showed a significant 31% reduction in the risk of death with primary implantable cardioverter-defibrillator (ICD) therapy during a median follow-up of 1.5 years. However, currently there are no data on the long-term efficacy of primary defibrillator therapy. Methods And Results-: MADIT-II enrolled 1232 patients with ischemic left ventricular dysfunction who were randomized to ICD and non-ICD medical therapy and were followed up through November 2001. For the present long-term study, we acquired posttrial mortality data through March 2009 for all study participants (median follow-up, 7.6 years). Multivariate Cox proportional hazards regression modeling was performed to calculate the hazard ratio for ICD versus non-ICD therapy during long-term follow-up. At 8 years of follow-up, the cumulative probability of all-cause mortality was 49% among patients treated with an ICD compared with 62% among non-ICD patients (P<0.001). Multivariate analysis demonstrated that ICD therapy was associated with a significant long-term survival benefit (hazard ratio for 0-through 8-year mortality=0.66 [95% confidence interval, 0.56 to 0.78]; P<0.001). Treatment with an ICD was shown to be associated with a significant reduction in the risk of death during the early phase of the extended follow-up period (0 through 4 years: hazard ratio=0.61 [95% confidence interval, 0.50 to 0.76]; P<0.001) and with continued life-saving benefit during the late phase of follow-up (5 through 8 years: hazard ratio=0.74 [95% confidence interval, 0.57 to 0.96]; P=0.02). Conclusions-: Our findings demonstrate a sustained 8-year survival benefit with primary ICD therapy in the MADIT-II population.

Original languageEnglish
Pages (from-to)1265-1271
Number of pages7
JournalCirculation
Volume122
Issue number13
DOIs
StatePublished - 28 Sep 2010
Externally publishedYes

Keywords

  • death, sudden
  • defibrillation
  • mortality

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