EVEREST II: Safety, efficacy remain stable at 2 years

Issue: May 2011

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS — Two-year data from the EVEREST II trial indicate that percutaneous repair with MitraClip is as effective as surgery in select patients with mitral regurgitation. Updated study results were presented here by study author Ted Feldman, MD, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in Illinois.

Initial results from EVEREST II demonstrated that the safety of MitraClip (Abbott Vascular) was greater compared with surgery, but also that MitraClip was inferior to surgery in reducing mitral regurgitation. One-year results were presented at the ACC 59th Annual Scientific Sessions in 2010. The current results suggest that at 2 years, 78% of patients who received the MitraClip device (Abbott Vascular) did not need surgery.

“The fundamental finding is that everything was very stable between 1 and 2 years. The Kaplan-Meier curves for mortality and reoperation remain, literally, completely flat through that time period. Gains in left ventricular performance and clinical outcome were very stable,” Feldman said during a press conference.

The study included 279 patients with grade 3+ or 4+ mitral regurgitation who were randomly assigned at 2:1 to receive the MitraClip (n=184) or standard surgery (n=95). Treatment efficacy was measured by freedom from death, absence of new mitral valve surgery and mitral regurgitation lower than grade 3+. Results were similar between the two groups: 62.7% of patients in the MitraClip group met this endpoint vs. 66.3% in the surgery group.

Major adverse events were significantly lower in the MitraClip group compared with surgery: 15% vs. 47.9% (P<.001). This difference is mainly explained, Feldman said, by the percentage of patients requiring a blood transfusion at ≥2 units (13.3% in the MitraClip arm vs. 44.7% in the surgery arm).

At 2 years, the researchers report no device embolization, fracture, erosion or migration. In addition, the occurrence of single leaflet device attachment remained unchanged between 1 and 2 years.

Primary effectiveness results were similar between years 1 and 2: 55.2% at 1 year vs. 51.7% at 2 years in the MitraClip group and 73.0% at 1 year vs. 66.3% at 2 years in the surgery group.

According to Feldman, both treatment strategies reduced mitral regurgitation and showed clinical benefit through 2 years, which includes significantly improved LV volumes and NYHA functional class. Follow-up will continue for 5 years. - Stacey L. Fisher

Disclosures: The EVEREST II study received funding from Evalve Inc. Dr. Feldman is a consultant for Abbott, which acquired Evalve in 2009.

For more information:

Feldman T. LBCT II, Session 3013. Presented at: ACC 60th Annual Scientific Sessions; April 2-5, 2011; New Orleans.

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