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MADIT II

Impact of the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II)

The landmark results of MADIT II provide hope for survival for many patients with prior myocardial infarction (MI) who would otherwise become victims of sudden cardiac death (SCD). Even with advancements in preventing recurrent MI and heart failure, SCD remains a major threat. Each year, SCD claims the lives of 300,000 Americans — with 80% to 90% of those deaths caused by ventricular fibrillation.1,2 Conventional antiarrhythmic drug therapy has proven to be not as effective in preventing SCD, as demonstrated in MADIT II.3-5

MADIT II was designed to determine if prophylactic implantable cardioverter defibrillator (ICD) therapy in moderately high-risk coronary patients — in addition to conventional therapy — would significantly reduce death compared with patients treated with conventional therapy alone.

The trial, which began July 11, 1997, was stopped by the Data and Safety Monitoring Board on November 20, 2001, after reaching the pre-specified efficacy boundary. The trial's principal investigator was Arthur J. Moss, MD, professor of medicine at the University of Rochester Medical Center in Rochester, New York.



References

  1. Myerburg RJ. Sudden cardiac death: exploring the limits of our knowledge. J Cardiovasc Electrophysiol. 2001;12:369-381.
  2. Moss AJ, Cannom DS, Daubert JP, et al, for the MADIT II Investigators. Multicenter Automatic Defibrillator Implantation Trial II (MADIT II): design and clinical protocol. Ann Noninvasive Electrocardiol. 1999;4:83-91.
  3. Echt DS, Liebson PR, Mitchell LB, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo: the Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1991;324:781-788.
  4. Waldo AL, Camm AJ, deRuyter H, et al, for the SWORD Investigators. Effect of d-sotalol on mortality in patients with left ventricular dysfunction after recent and remote myocardial infarction. Lancet. 1996;348:7-12.
  5. Farré J, Romero J, Rubio JM, Ayala R, Castro-Dorticós J. Amiodarone and "primary" prevention of sudden death: critical review of a decade of clinical trials. Am J Cardiol. 1999;83:55D-63D.

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