Two-Year EVEREST II Data Support Abbott Vascular's MitraClip

May 25, 2010—Abbott Vascular (Santa Clara, CA) announced new data from the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) trial that were presented by coprincipal investigator Ted Feldman, MD, at the EuroPCR 2010 conference in Paris. The company stated that these data build on the positive EVEREST II primary endpoint results that were presented during the American College of Cardiology 2010 meeting in March and provide additional details about the safety and clinical benefit of Abbott Vascular’s investigational MitraClip system for treating the two causes of mitral regurgitation (MR)—functional MR (FMR) and degenerative MR (DMR).

According to Abbott Vascular, the EVEREST II pivotal trial is a multicenter, randomized clinical trial of 279 patients with moderate-to-severe (3+) or severe (4+) MR who were candidates for mitral valve surgery. Patients were selected for treatment with the MitraClip device if they met the criteria for surgical intervention from the 1998/2006 American College of Cardiology/American Heart Association Joint Task Force Recommendations regarding therapy for valvular heart disease.


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% and 8.1%, respectively), and both were 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 1 year from baseline measures of heart function, symptoms, and quality of life.

Additionally, Abbott Vascular presented results on a subset of patients within the EVEREST II trial who had progressed to 2 years after the procedure, which showed that the positive clinical results achieved at 1 year with the MitraClip system are sustained at 2 years in patients with significant MR. The preliminary 2-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 between these two groups in the need for subsequent mitral valve surgery through 2 years.
The patient subgroup analysis included 135 patients with DMR and 49 patients with FMR. At 1 year, the MitraClip procedure demonstrated the subsequent results in FMR and DMR patients:

• An improvement in heart function as indicated by a reduction in both left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV). In FMR patients, LVEDV decreased 10.6% and LVESV decreased 7.7% compared to baseline. Similarly, in DMR patients, LVEDV decreased 15% and LVESV decreased 6.7% compared to baseline.
• An improvement in symptoms, with 96.7% of FMR patients and 97.8% of DMR patients exhibiting no symptoms (New York Heart Association [NYHA] functional class I) or mild symptoms (NYHA functional class II), whereas at baseline, 64.5% of FMR patients and 45.2% of DMR patients had moderate symptoms (NYHA functional class III) or severe symptoms (NYHA functional class IV).
• Meaningful improvements in both physical and mental quality of life compared to baseline as measured by the SF-36 Survey (increase of 1.6 points for FMR patients and 5.6 points for DMR patients in the physical quality-of-life score; increase of 8.7 points for FMR patients and 5 points for DMR patients in the mental quality-of-life score).

“The patient subgroup analysis shows that the catheter-based clip device delivers consistent results regardless of FMR or DMR etiology,” commented Dr. Feldman. “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. In addition, the data on the durability of the clip device compared to surgery through 2 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 received CE Mark in March 2008. In the United States, the MitraClip device is available for investigational use only and is currently under review for approval by the US Food and Drug Administration, the company advised.