Title: Endovascular Valve Edge-to-Edge Repair Study II (EVEREST II)
Year Presented: 2010
Topic(s): Cardiovascular Surgery
Summary Posted: 3/14/2010
Writer: Anthony A. Bavry, M.D., M.P.H., F.A.C.C.
Author Disclosure: This author has nothing to disclose.
Reviewer: Deepak L. Bhatt, M.D., M.P.H., F.A.C.C.
Author Disclosure: Research/Research Grants: Astra Zeneca; Consultant Fees/Honoraria: Duke Clinical Research Institute; Research/Research Grants: Heartscape; Research/Research Grants: PLx Pharma; Research/Research Grants: Cogentus; Research/Research Grants: Sanofi Aventis; Data Safety Monitoring Board (Gov’t/Nonprofit): Duke Clinical Research Institute; Research/Research Grants: Bristol Myers Squibb; Research/Research Grants: Eisai; Research/Research Grants: Takeda; Research/Research Grants: The Medicines Company; Research/Research Grants: Ethicon
Description
The goal of the trial was to evaluate treatment with the percutaneous MitraClip device compared with surgical mitral valve repair/replacement among patients with severe mitral regurgitation.
Hypothesis
Percutaneous mitral valve repair would be noninferior in regards to effectiveness and superior in regards to safety.
Drugs/Procedures Used
Patients with severe mitral regurgitation (3 to 4+) were randomized to the percutaneous mitral valve clip (n = 184) versus surgical repair/replacement (n = 95).
Principal Findings
Overall, 279 patients were enrolled. In the mitral clip group, the mean age was 67 years, 63% were men, 34% had atrial fibrillation, the mean ejection fraction was 60%, 8% had diabetes, 73% had a degenerative mitral valve, and 27% had functional mitral regurgitation. The only baseline characteristic that was different between the groups was congestive heart failure, which was present in 91% of the clip group and 78% of the control group (p < 0.01).
In the per-protocol analysis, 41 patients in the clip group did not achieve procedural success and were not analyzed further. Major adverse events at 30 days occurred in 9.6% of the clip group versus 57% of the control group (p < 0.0001 for superiority). This outcome was driven by increased need for blood transfusion in the control group. Clinical success rate at 12 months was 72% versus 88% (p = 0.0012 for noninferiority), respectively.
In the intention-to-treat analysis, major adverse events at 30 days occurred in 15% of the clip group versus 48% of the control group (p < 0.0001 for superiority). Clinical success rate at 12 months was 67% versus 74% (p = 0.0005 for noninferiority), respectively.
In the per-protocol group, 82% achieved 2+ or less mitral regurgitation versus 97% in the control group. New York Heart Association (NYHA) class I or II at follow-up was 98% in the clip group versus 88% in the control group.
Interpretation
Among patients with severe mitral regurgitation, repair with a percutaneous mitral valve clip was feasible. This therapy demonstrated improved safety at 30 days compared with surgery, largely by reducing the need for blood transfusion. The mitral valve clip was also noninferior for effectiveness at 12 months.
Conditions
• Valvular heart disease
• Prevention
Study Design
Randomized. Parallel.
Patients Enrolled: 279
Mean Follow-Up: 12 months
Mean Patient Age: 67 years
% Female: 38%
Mean Ejection Fraction: 60%
Primary Endpoints
Primary effectiveness endpoint: Freedom from death, surgery for mitral valve dysfunction, and >2+ mitral regurgitation at 12 months
Primary safety endpoint: Death, myocardial infarction, re-operation for failed surgical repair/replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for more than 48 hours, gastrointestinal complication requiring surgery, new-onset atrial fibrillatin, sepsis, and transfusion of ≥2 U blood
Secondary Endpoints
Quality of life
NYHA functional class
Patient Population
Patients with severe mitral regurgitation (3 to 4+) and candidate for mitral valve surgery
Symptomatic: left ventricular (LV) ejection fraction >25% and LV end-systolic dimension <56 mm
Asymptomatic (with one or more of the following): LV ejection fraction 25-60%, LV end-systolic dimension >39, or new-onset atrial fibrillation, or pulmonary hypertension
Exclusions:
Myocardial infarction within 12 weeks
Need for other cardiac surgery
Serum creatinine >2.5 mg/dl
Endocarditis
Rheumatic heart disease
Mitral valve anatomical exclusions: mitral valve area <4 cm2, leaflet flail width (>14 mm) and gap (>9 mm), or leaflet tethering/coaptation depth (>11 mm) and length (<2 mm)
References: Presented by Dr. Ted Feldman at the ACC.10/i2 Summit, Atlanta, GA, March 2010.