Data From Landmark Clinical Trial of Abbott's MitraClipÃ‚® System Demonstrate Durable Clinical Benefits for Patients With Mitral Regurgitation Two Years After Treatment
NEW ORLEANS, April 4, 2011 /PRNewswire/ -- Abbott (NYSE: ABT) today announced data from its EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) study showing that patients with significant mitral regurgitation (MR) treated with the company's investigational percutaneous catheter-based MitraClip® system continue to demonstrate the clinical benefits of initial treatment shown at one year out to two years, including improvements in heart function and reductions in symptoms. EVEREST II is the first randomized clinical trial to compare a catheter-based mitral valve device to mitral valve surgery. Data from the study were published in The New England Journal of Medicine and presented in a late-breaking clinical trial session at the American College of Cardiology's (ACC) 60th Annual Scientific Session and i2 Summit 2011 in New Orleans.
At two years after treatment, data from 279 patients from the EVEREST II trial demonstrated a clinical success rate of 51.7 percent for patients treated with the MitraClip device compared to a clinical success rate of 66.3 percent for surgery patients (p=0.04) on an Intention-to-Treat (ITT) basis. These results compare with the one-year data, which demonstrated a clinical success rate of 55.2 percent for patients who received the MitraClip device, compared to a clinical success rate of 73.0 percent for surgery patients (p=0.0007). The clinical success rate is defined as freedom from death, from surgery for valve dysfunction, and from moderate to severe MR (3+ or 4+).
In The New England Journal of Medicine, the study authors, who represent a variety of specialties including cardiac surgery and interventional cardiology, state that "although percutaneous repair was less effective at reducing mitral regurgitation than surgery before hospital discharge, at 12 and 24 months the rates of reduction in mitral regurgitation were