multicenter automatic defibrillator implantation trial II (MADIT II) The Question Patients who have had a heart attack and who have poor cardiac pumping function are at a higher risk for sudden cardiac arrest (also called sudden cardiac arrest). In order to reduce the large number of sudden cardiac arrests that occur annually in the United States, it is important to intervene in high-risk patients prior to the event. Will the use of implantable cardioverter-defibrillator devices (ICDs) in moderately high-risk patients significantly reduce death compared with patients treated with medical treatment alone? This Study Note: A prior trial – MADIT, the first Multicenter Automatic Defibrillator Implantation Trial, showed that patients with coronary heart disease, a reduced left ventricular ejection fraction, unsustained ventricular tachycardia and inducible sustained ventricular tachyarrhythmias in the electrophysiology lab benefited from ICD implantation. MADIT II did not require the electrophysiological testing of the first trial, broadening the patient population. MADIT II enrolled 1,232 patients from 76 centers in the United States and Europe. All patients suffered from coronary artery disease, had experienced a myocardial infarction at least 30 days prior to study enrollment, and had poor cardiac pumping function (left ventricular ejection fraction ≤30%). Patients were assigned to two groups: 1) medical therapy alone, and 2) medical therapy plus an ICD. The mortality rate was 19.8% in the conventional medical therapy group versus 14.2% in the ICD group. The trial, which began July 11, 1997, was stopped early by the Data and Safety Monitoring Board on November 20, 2001, after data showed a 31% decrease in mortality for those patients receiving an ICD versus those receiving medical therapy alone. Bottom Line Heart attack survivors treated with medical therapy and an ICD have a reduced risk of death compared to those treated only with medical therapy. Who may be affected by these findings? Following publication of the MADIT II findings, a joint committee from the American College of Cardiology, the Heart Rhythm Society and the American Heart Association released new guidelines for the use ICDs. Approximately 10 to 15 percent of the 1 million annual U.S. heart attack survivors meet the MADIT II criteria and would be indicated for an ICD under the newly released guidelines. Caveats The potential patient population that could benefit from such ICD treatment is large - an estimated three to four million patients have coronary artery disease and advanced left ventricular dysfunction in the United States, with an estimated 400,000 new cases annually. Find this Study New England Journal of Medicine 2002;346:877-83 http://content.nejm.org/cgi/content/full/346/12/877?ijkey=8v5Z.lX5/FtZY&keytype=ref&siteid=nejm Sponsor Guidant Corporation. Presented at the American College of Cardiology Scientific Sessions in March of 2002.