Arthur Moss, professor of Medicine at the University of Rochester Medical Center and principal investigator of the trial, presented the MADIT-CRT data. The primary endpoint showed that cardiac resynchronization therapy defibrillators (CRT-Ds) were associated with a 34% relative reduction in the risk of all-cause mortality or first heart failure event in asymptomatic and mild (NYHA Class I and II ) heart failure patients, when compared to standard implantable cardioverter defibrillators (ICDs) (p=0.001).
Results also revealed that CRT-D therapy reduces the relative risk of heart failure events by 41% when compared to ICD therapy (p< 0.001). Patients treated with CRT-D therapy showed an improvement of 11% in Left Ventricular Ejection Fraction after one year, compared to a 3% improvement for ICD patients.
Mr. Moss said: The MADIT-CRT Executive Committee anticipated that the benefit for the CRT-D therapy group would be dominated by a reduction in heart failure events and the data overwhelmingly confirm that. Furthermore, CRT-D therapy showed an equal benefit in both ischemic and non-ischemic patients. The MADIT-CRT data are compelling and help bridge a clinical gap in our understanding of heart failure in Class I and II patients.
Fred Colen, president of Boston Scientific Cardiac Rhythm Management, said: The publication of the manuscript by the New England Journal of Medicine and the presentation of MADIT-CRT data at ESC highlight the importance of this study, which clearly demonstrates that CRT-D therapy slows the progression of heart failure, further delaying the onset of more severe and life-limiting conditions. We look forward to working with the FDA as we seek approval for an expanded indication for our CRT-D devices, based on these strong results.
Boston Scientific is a developer, manufacturer and marketer of medical devices whose products are used in a range of interventional medical specialties.
