Endovascular Valve Edge-to-Edge Repair Study II - EVEREST II: Follow-Up to 5 Years

Jan 21, 2016
Font Size
A
A
A
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Abbott Vascular
Date Presented:
04/04/2011
Date Published:
12/29/2015
Date Updated:
01/21/2016
Original Posted Date:
07/15/2014
References

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.

EVEREST II showed that patients with severe mitral regurgitation (grade 3 to 4+) who were treated with percutaneous repair required more valve surgery within the first year compared with those initially treated with surgery.

Study Design

  • Parallel

Patients with severe mitral regurgitation (grade 3 to 4+) were randomized to the percutaneous mitral valve clip (n = 184) versus surgical repair/replacement (n = 95).

Patients Enrolled: 279
Mean Follow-Up: 5 years
Mean Patient Age: 67 years
Female: 38%
Mean Ejection Fraction: 60%

Patient Populations:

  • 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 ≤55 mm
  • Asymptomatic (with one or more of the following): LV ejection fraction 25-60%, LV end-systolic dimension ≥40, 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 (≥15 mm) and gap (≥10 mm), or leaflet tethering/coaptation depth (>11 mm) and length (<2 mm)

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 fibrillation, sepsis, and transfusion of ≥2 U blood

Secondary Endpoints:

  • Quality of life
  • NYHA functional class

Drug/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 percutaneous mitral repair group, the mean age was 67 years, 62% 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 percutaneous mitral repair group and 78% of the surgical repair/replacement group (p = 0.005).

The primary effectiveness outcome at 1 year (intention-to-treat), defined as freedom from death, mitral valve surgery (in the percutaneous group) or reoperation (in the surgical group), or 3 to 4+ mitral regurgitation occurred in 55% of the percutaneous group versus 73% of the surgical group (p = 0.007).

Rates of death were 6% versus 6%, surgery for mitral valve dysfunction was 20% versus 2.2%, and 3+ to 4+ mitral regurgitation was 21% versus 20%, respectively, for percutaneous versus surgical groups. In a per-protocol analysis, freedom from the primary outcome at 1 year occurred in 72% versus 88% (p = 0.02), respectively. The primary effectiveness outcome at 2 years (intention-to-treat) occurred in 52% versus 66% (p = 0.04), respectively. The primary effectiveness outcome at 5 years occurred in 44% versus 64% (p = 0.003), respectively.

The primary safety outcome at 30 days, defined as any major adverse event, occurred in 15% of the percutaneous mitral repair group versus 48% of the surgical repair/replacement group (p < 0.001). This was due to a lower frequency of blood transfusion in the percutaneous group: 13% versus 45% (p < 0.001). The rate of major adverse events excluding blood transfusion was 5% versus 10% (p = 0.23), respectively. Other individual components of safety were death: 1% versus 2%, urgent/emergent surgery for adverse event: 2% versus 4%, major stroke: 1% versus 2%, ventilation for >48 hours: 0% versus 4%, and new onset of permanent atrial fibrillation: 1% versus 0%, respectively.

Change in left ventricular end-systolic dimension from baseline to 12 months was -5.5 ml in the percutaneous group versus -5.6 ml in the surgical group (p = 0.97). Change in ejection fraction was -2.8% versus -6.8% (p = 0.005), respectively. Physical and mental quality of life improved to a similar degree in both groups.

Among high-risk participants (mean age 76 years), functional mitral regurgitation was present in 70%. One mitral valve device was implanted in 57.3%, while two mitral valve devices were implanted in 38.5%. Mitral regurgitation ≤2+ was present in 86% of participants at discharge and in 84% at 12 months.

Interpretation:

Among patients with severe mitral regurgitation, repair with a percutaneous mitral valve clip is feasible. This therapy demonstrated improved safety at 30 days compared with surgery, largely by reducing the need for blood transfusion. The primary effectiveness outcome favored surgery at 1 year due to more complete resolution of mitral regurgitation. However, beyond 1 year, the need for surgery or moderate to severe mitral regurgitation was similar between the groups. Left ventricular dimension was reduced to a similar degree in both groups, although ejection fraction declined by a greater extent in the surgical group. Among high-risk patients with functional mitral regurgitation, percutaneous mitral valve repair significantly reduced mitral regurgitation and improved clinical symptoms.

References:

Feldman T, Kar S, Elmariah S, et al. Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation: 5-Year Results of EVEREST II. J Am Coll Cardiol 2015; 66:2844-54.

Editorial Comment: Anyanwu AC, Adams DH. Evaluating Catheter-Based Mitral Valve Therapies: Lessons Learned and Future Directions. J Am Coll Cardiol 2015;66:2855-9.

Glower DD, Kar S, Trento A, et al. Percutaneous Mitral Valve Repair for Mitral Regurgitation in High-Risk Patients: Results of the EVEREST II Study. J Am Coll Cardiol 2014;64:172-81.

Editorial: Carabello BA. Treatment for Mitral Regurgitation: Which One Are We Talking About? J Am Coll Cardiol 2014;64:193-5.

Feldman T, Foster E, Glower D, et al., on behalf of the EVEREST II Investigators. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med 2011;364:1395-1406.

Presented by Dr. Ted Feldman at the ACC.11/i2 Summit, New Orleans, LA, April 4, 2011.

Presented by Dr. Ted Feldman at the ACC.10/i2 Summit, Atlanta, GA, March 2010.

Keywords: Stroke, Myocardial Infarction, Pyridinolcarbamate, Mitral Valve Insufficiency, Blood Transfusion, Registries, Reoperation, Quality of Life, Heart Failure, Hypertension, Pulmonary, Heart Valve Diseases, Diabetes Mellitus


< Back to Listings