Tuesday, June 23, 2009

MADIT-CRT Meets Primary Endpoint

From a press release, just released:
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.

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.
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.

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.


1 comment:

efpat said...

Dr. Wes,

I am a 51 year old man who is NYHA class 1. It has been suggested I get a CRT-D device. I have never had any "event". I've been waiting for the results of MADIT-CRT and may still wait for the complete results. I'd love to know the need to treat number. As for your last comment, I agree. I don't see the insurance companies getting behind implanting a very expensive device in millions of people with no symptoms.