title: 4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation.
abstract: OBJECTIVE
  This study sought to evaluate 4-year outcomes of percutaneous repair versus surgery for mitral regurgitation.
  
  
  BACKGROUND
  Transcatheter therapies are being developed to treat valvular heart disease. In the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II trial, treatment of mitral valve regurgitation (MR) with a novel percutaneous device was compared with surgery and showed superior safety, but less reduction in MR at 1 year overall. We report the 4-year outcomes from the EVEREST II trial.
  
  
  METHODS
  Patients with grade 3+ or 4+ MR were randomly assigned to percutaneous repair with the MitraClip (Abbott, Menlo Park, California) device or conventional mitral valve surgery in a 2:1 ratio (184:95). Patients prospectively consented to 5 years of follow-up.
  
  
  RESULTS
  At 4 years, the rate of the composite endpoint of freedom from death, surgery, or 3+ or 4+ MR in the intention-to-treat population was 39.8% versus 53.4% in the percutaneous repair group and surgical groups, respectively (p = 0.070). Rates of death were 17.4% versus 17.8% (p = 0.914), and 3+ or 4+ MR was present in 21.7% versus 24.7% (p = 0.745) at 4 years of follow-up, respectively. Surgery for mitral valve dysfunction, however, occurred in 20.4% versus 2.2% (p < 0.001) at 1 year and 24.8% versus 5.5% (p < 0.001) at 4 years.
  
  
  CONCLUSIONS
  Patients treated with percutaneous repair of the mitral valve more commonly required surgery to treat residual MR; however, after the first year of follow-up, there were few surgeries required after either percutaneous or surgical treatment and no difference in the prevalence of moderate-severe and severe MR or mortality at 4 years. (Endovascular Valve Edge-to-Edge Repair Study [EVEREST II]; NCT00209274).
authors.affiliation: Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA 02115, USA. lmauri1@partners.org
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
authors.forename: Elyse
authors.initials: E
authors.lastname: Foster
authors.forename: Donald D
authors.initials: DD
authors.lastname: Glower
authors.forename: Patricia
authors.initials: P
authors.lastname: Apruzzese
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Massaro
authors.forename: Howard C
authors.initials: HC
authors.lastname: Herrmann
authors.forename: James
authors.initials: J
authors.lastname: Hermiller
authors.forename: William
authors.initials: W
authors.lastname: Gray
authors.forename: Andrew
authors.initials: A
authors.lastname: Wang
authors.forename: Wesley R
authors.initials: WR
authors.lastname: Pedersen
authors.forename: Tanvir
authors.initials: T
authors.lastname: Bajwa
authors.forename: John
authors.initials: J
authors.lastname: Lasala
authors.forename: Reginald
authors.initials: R
authors.lastname: Low
authors.forename: Paul
authors.initials: P
authors.lastname: Grayburn
authors.forename: Ted
authors.initials: T
authors.lastname: Feldman
mesh_terms: D005500:Follow-Up Studies; D006801:Humans; D008944:Mitral Valve Insufficiency / Q000175:diagnosis* / Q000401:mortality / Q000601:surgery*; D062645:Percutaneous Coronary Intervention / Q000379:methods / Q000401:mortality / Q000592:standards*; D011446:Prospective Studies; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome
keywords: LVEF; LVIDd; MR; NYHA; New York Heart Association; left ventricular ejection fraction; left ventricular internal diameter diastolic; mitral regurgitation; mitral repair; percutaneous valve therapy