Late-Breaking Clinical Trial Results Announced at Heart Rhythm 2009: MADIT-II Trial
New trial reveals long-term outcomes of patients treated with an ICD, sustained survival benefits after eight years of follow-up

FOR IMMEDIATE RELEASE
Contact: Ann-Marie White
Heart Rhythm Society
(202) 464-3476
awhite@hrsonline.org

Lucy McDonald: (202) 306-3456
Heart Rhythm 2009 Press Room: (617) 954-3399 (number effective May 13-16, 2009)

BOSTON, May 14, 2009 — Results of the Multicenter Automatic Defibrillator Trial II (MADIT-II), a late-breaking clinical trial presented today at Heart Rhythm 2009, the Heart Rhythm Society’s 30th annual Scientific Sessions, show a significant reduction in the risk of long-term mortality in patients with an implantable cardioverter defibrillator (ICD) versus patients without an ICD. During an eight-year follow-up period, multivariate analysis demonstrated that ICD therapy is associated with improved survival for patients with serious heart health risks.
     » Download Long-Term Outcome after Implantation of a Cardioverter Defibrillator: An Eight Year Follow-Up Study of the Multicenter Automatic Defibrillator Trial II abstract (PDF, 111K)

The MADIT-II trial enrolled 1,232 patients with ischemic left ventricular dysfunction and follow-up was conducted through November 2001. For the current long-term efficacy study, researchers acquired post-trial mortality data for all study patients from the U.S. and European National Death Registries. Modeling was carried out to determine the long-term outcomes of patients with an ICD versus patients not treated with an ICD.

“The results of the extended follow-up of the MADIT-II trial provide hope for long-term survival among patients suffering from life-threatening heart conditions that can often times lead to sudden cardiac death, a leading killer in this country and abroad,” stated lead author Ilan Goldenberg, MD, of the Heart Research Follow-up Program at the University of Rochester Medical Center in Rochester, New York. “This study proves that ICD therapy, sustained for over eight years, does in fact improve survival rates and ultimately save lives.”

After a cumulative follow-up period of eight years, results of the MADIT-II trial reveal an all-cause mortality probability of 45 percent among patients with an ICD as compared to 61 percent among patients without an ICD. The 16 percent increase corresponds to 1.2 life-years saved with an ICD during an eight-year period.

While ICD therapy was shown to result in significant survival benefits in the first four years of follow-up, analysis proves that ICD therapy was associated with additional life-saving benefits during the extended four to eight years of follow-up, proving the overall survival benefit from an ICD was sustained over an eight year period. The study also found that long-term device efficacy was enhanced among patients who received a limited amount of right ventricular pacing from the ICD and among those who did not develop heart failure progression during the study.

Session details:
“Late-Breaking Clinical Trials I” [May 14, 2009, 10:30 a.m. – 12:00 p.m., Ballroom West]

About Heart Rhythm 2009
Heart Rhythm 2009 takes place May 13-16 at the Boston Exhibition and Convention Center. The meeting is the most comprehensive educational event on heart rhythm disorders, offering approximately 250 educational opportunities in multiple formats. The world’s most renowned scientists and physicians will present a wide range of heart rhythm topics including cardiac resynchronization therapy, catheter ablation, cardiac pacing and heart failure as well as the latest technology, including state-of-the-art pacemakers and defibrillators.