NATICK, Mass., Feb. 8, 2011 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today welcomed the publication of a sub-analysis of the MADIT-CRT trial data in the current issue of the Journal of American College of Cardiology that showed women received a greater clinical benefit from cardiac resynchronization therapy defibrillators (CRT-Ds) than men.
The sub-analysis demonstrated that both men and women experienced significant benefit from cardiac resynchronization therapy. However, women experienced a 70 percent reduction in heart failure events compared to a 35 percent reduction for men. Additional analysis demonstrated that women with asymptomatic or mild heart failure experienced a 72 percent reduction in all-cause mortality.
"CRT-D therapy has historically been underutilized in women compared to men with the same severity of heart disease," said Kenneth Stein, M.D., Senior Vice President and Chief Medical Officer, CRM, for Boston Scientific's Cardiology, Rhythm and Vascular Group. "Boston Scientific believes that all patients, regardless of gender, should have equal access to high-quality cardiovascular care. We believe these findings will help draw attention to the benefits of CRT-D treatment for women, and therefore help reduce treatment disparities between women and men."
A number of factors may have contributed to women experiencing a greater CRT-D benefit than men:
- MADIT-CRT found that Left Bundle Branch Block (LBBB) is an objective discriminator for a positive response to CRT and women in the trial were more likely than men to have LBBB.
- CRT-D therapy is designed to improve the heart's overall pumping ability and women are more likely than men to have non-ischemic heart disease(1). Conversely, men are more likely to have ischemic heart disease (also known as coronary artery disease), which often leads to a more localized impact on heart function.
MADIT-CRT is the world's largest randomized CRT-D study of New York Heart Association (NYHA) Class I and II patients(2), with more than 1,800 patients enrolled at 110 centers worldwide. Results of the MADIT-CRT trial were published in the October 2009 issue of the New England Journal of Medicine.
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(1) Non-ischemic heart disease 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.
(2) The NYHA 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. MADIT-CRT patients are asymptomatic or mildly symptomatic, NYHA Class I (ischemic) and Class II (ischemic and non-ischemic).
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