Boston Scientific has unveiled final results from the landmark MADIT-CRT trial, which were published by the New England Journal of Medicine and presented at the annual European Society of Cardiology (ESC) Congress in Barcelona.
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.