Boston Scientific Corporation (NYSE: BSX) and the University of Rochester Medical Center today announced that the landmark MADIT-CRT trial has met its primary endpoint. Preliminary results show Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) to be associated with a significant 29 percent reduction (p=0.003) in death or heart failure interventions when compared to traditional implantable cardioverter defibrillators (ICDs). High risk(1), asymptomatic or mildly symptomatic, New York Heart Association (NYHA) Class I and II(2) patients were enrolled in MADIT-CRT. The MADIT-CRT Executive Committee expects to present and publish the trial's full results later this year.The MADIT-CRT trial was designed to determine if combined implantable cardiac defibrillator (ICD)-cardiac resynchronization therapy (CRT-D) would reduce the risk of mortality and heart failure (HF) events by approximately 25%, in subjects who were in New York Heart Association (NYHA) functional Class II with non-ischemic or ischemic cardiomyopathy and subjects who are in NYHA functional Class I with ischemic cardiomyopathy, left ventricular dysfunction (ejection fraction [EF] < or = 0.30), and prolonged intraventricular conduction (QRS duration > or = 130 ms). 60% of patients were randomized to CRT-D and 40% to ICD only.
MADIT-CRT, sponsored exclusively by Boston Scientific, demonstrates that early intervention with cardiac resynchronization therapy can slow the progression of heart failure. It is the world's largest randomized NYHA Class I/II CRT-D trial, with more than 1,800 patients enrolled at 110 centers in 14 countries. The trial is being conducted under the leadership of Principal Investigator Arthur J. Moss, M.D., Professor of Medicine at the University of Rochester Medical Center.
This news could not come sooner to the medical device industry, but the fiscal realities before us make me wonder if soon we will dealing with medical device benefits managers, just like we're dealing with pharmaceutical benefits managers.