Boston Scientific announced on 18 June 2010 results from a sub-analysis of the MADIT-CRT trial data that showed women received a greater clinical benefit from its cardiac resynchronisation therapy defibrillators (CRT-Ds) than men. The results were presented during the 17th Cardiostim World Congress, in Nice, France, by Jonathan Steinberg, chief of Cardiology and Director of the Al-Sabah Arrythmia Institute, St Luke’s-Roosevelt Hospital Center, New York, USA.
The sub-analysis demonstrated that both men and women experienced significant benefit from cardiac resynchronisation therapy. However, women experienced a 70% reduction in heart failure events compared to a 35% reduction for men. Additional analysis demonstrated that women with asymptomatic or mild heart failure experienced a 72% reduction in all-cause mortality.
“There are a number of factors that may explain why women experienced a greater benefit than men,” said Arthur Moss, professor of Medicine at the University of Rochester Medical Center and principal investigator of the MADIT-CRT trial. “CRT-D therapy is designed to improve the heart’s overall pumping ability and women are more likely than men to have non-ischaemic heart disease, which typically affects the entire heart rather than a single region and can lead to reduced pumping strength, abnormal heart rhythms and disturbances in the heart’s electrical system. Men are more likely to have ischaemic heart disease, also known as coronary artery disease, which often leads to a more localised impact on the heart.”
“These findings are noteworthy because CRT-D therapy has historically been underutilised in women compared to men with the same level of heart disease,” said Kenneth Stein, chief medical officer, CRM, for Boston Scientific’s Cardiology, Rhythm and Vascular Group. “Boston Scientific believes that all patients should have equal access to high-quality cardiovascular care regardless of gender. We believe these findings will help reduce treatment disparities between men and women.”
MADIT-CRT is the world’s largest randomised CRT-D study of New York Heart Association (NYHA) Class I and II patients, with more than 1,800 patients enrolled at 110 centres worldwide. Results of the MADIT-CRT trial were published in the October 2009 issue of the New England Journal of Medicine. Boston Scientific currently has an application under review with the FDA for the expansion of its CRT-D indication to include high-risk NYHA Class I and II patients with left bundle branch block.