COAPT study of Mitra Clip System meets endpoints in mitral regurgitation.- Abbott.

Abbott announced positive clinical study results from a randomized controlled trial comparing treatment with the MitraClip device to guideline-directed medical therapy in select patients with secondary (or functional) mitral regurgitation, or a leaky heart valve, as a result of advanced heart failure. The landmark COAPT study met both the primary safety and efficacy endpoints and all secondary endpoints, and showed treatment with MitraClip plus medical therapy was superior to medical therapy alone in reducing rates of heart failure hospitalizations and improving survival at two years. This therapeutic mitral valve intervention is the first and only to demonstrate positive outcomes in a clinical trial for ailing heart failure patients with clinically significant secondary mitral regurgitation.

Treatment with MitraClip plus medical therapy resulted in a statistically significant reduction in heart failure hospitalization through two years compared to medical therapy alone (annualized rate of 67.9 percent per year vs. 35.8 percent per year; p<0.001). mitraclip treatment reduced all-cause mortality through two years, from 46.1 percent of patients in the control group to 29.1 percent in the device group at two years of follow-up (p><0.001). at one year, freedom from device-related complications was 96.6 percent, exceeding the performance goal for the primary safety endpoint (p><0.001).>

Patients in the device group experienced significant reduction in MR severity (at one year, MR < 2+ was present in 94.8 percent of patients in the device group and in 46.9 percent of patients in the control group; p<0.001) and nyha class (at one year, nyha class i or ii was present in 72.2 percent of patients in the device group and in 49.6 percent of patients in the control group; p><0.001). treatment with mitraclip provided a substantial improvement in patients' perception of their health status, measured by the kccq quality-of-life score, and functional capacity at one year. mitraclip treatment resulted in a reduction in the composite of death or first heart failure hospitalization by 43.0 percent.>

The results were consistent across numerous subgroups, including patients with ischemic and non-ischemic cardiomyopathy � a disease of the heart muscle that weakens the ability of the heart to pump blood to the rest of the body � and those at high and low surgical risk. The data were presented during a late-breaking session at the 30th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium.