MADIT-CRT Trial Meets Primary Endpoint

Main Category: Heart Disease
Also Included In: Cardiovascular / Cardiology;  Clinical Trials / Drug Trials
Article Date: 24 Jun 2009 - 3:00 PDT

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Boston Scientific Corporation (NYSE: BSX) and the University of Rochester Medical Center 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.

"We are very encouraged by these initial positive results, and we are hopeful they will eventually lead to a wider population of heart failure patients being treated with CRT-D therapy," said Fred Colen, President, Boston Scientific CRM. "I would like to congratulate Dr. Moss, the Executive Committee and all the MADIT-CRT investigators on a well designed and well executed clinical trial. Boston Scientific is proud to continue the tradition of supporting advances in indications in the CRM space through trials like MADIT-CRT. More than 80 percent of U.S. patients who receive an ICD or CRT-D were first indicated for this therapy by a clinical trial sponsored by Boston Scientific or its predecessors(3)."

MADIT-CRT is providing insight into the potential of CRT-D therapy to intervene earlier in the natural progression of heart failure. Currently, patients must be in NYHA Class III/IV heart failure to be indicated for CRT-D therapy. However, approximately 70 percent of all heart failure patients in the U.S. fall into Class I or II. Nearly 22 million people worldwide, including approximately 5.5 million Americans, suffer from some form of heart failure.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.

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References

(1) High-risk is defined as QRS width greater than or equal to 130 milliseconds and Left Ventricular Ejection Fraction less than or equal to 30 percent.

(2) The New York Heart Association clinical classifications of heart failure rank patients as Class I-II-III-IV, according to the degree of symptoms or functional limits, from asymptomatic to bed ridden.

(3) Trials include MADIT, MADIT-II, CONTAK-CD and COMPANION.

Source: Boston Scientific Corporation