Abbott announced on 25 May 2010 new data from the landmark EVEREST II (Endovascular valve edge-to-edge repair study) trial, which provide additional details about the safety and clinical benefit of the MitraClip system for the two causes of mitral regurgitation (MR) – functional MR (FMR) or degenerative MR (DMR).
In the EVEREST II trial, the 30-day major adverse event rate in the MitraClip arm was similar for the FMR and DMR patient subgroups (8.2% for FMR patients, 8.1% for DMR patients), both lower than the surgical control group (42.6%). The MitraClip system also demonstrated consistent results in both FMR and DMR patients with both subgroups showing significant improvement at one year from baseline measures of heart function, symptoms and quality of life. These results were presented during the Late Breaking Registries and Clinical Trial Updates session at the EuroPCR 2010 conference, Paris, France, and build upon the positive EVEREST II primary endpoint results that were presented during the American College of Cardiology 2010 meeting in March.
Additionally, Abbott presented results on a subset of patients within the EVEREST II trial who had progressed to two years post procedure, which showed that the positive clinical results achieved at one year with the MitraClip system are sustained at two years in patients with significant MR. The preliminary two-year results evaluated 86 of the 217 patients who had successful MR reduction after treatment with a MitraClip device or open heart surgery, and showed there was no difference in the need for subsequent mitral valve surgery through two years between these two groups.
“The patient subgroup analysis shows that the catheter-based clip device delivers consistent results regardless of FMR or DMR etiology. These results are important because they are consistent with the results achieved in the EVEREST High Risk Registry Study, indicating the device may be an option for treatment for a range of patients with MR,” said Ted Feldman, director, Cardiac Catheterization Laboratory, and The Mr. and Mrs. Charles R. Walgreen Chair in Interventional Cardiology, NorthShore University HealthSystem, Evanston, USA, and co-principal investigator of the EVEREST II trial. “In addition, the data on the durability of the clip device compared to surgery through two years adds to my confidence that a treatment strategy with the clip may be a viable choice for certain patients who are looking for other options to treat their leaky heart valve.”
The MitraClip system includes a catheter-based device, which is delivered to the heart through the femoral vein. The MitraClip device is designed to reduce significant MR by clipping together the leaflets of the mitral valve. The MitraClip system received CE mark in March 2008. The MitraClip system is currently under review for approval by the FDA.