title: 2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement.
abstract: BACKGROUND
  The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery, the 1-year survival rate was 4.9 percentage points higher in patients treated with a self-expanding transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis.
  
  
  OBJECTIVE
  Longer-term clinical outcomes were examined to confirm if this mortality benefit is sustained.
  
  
  METHODS
  Patients with severe aortic stenosis who were at increased surgical risk were recruited. Eligible patients were randomly assigned in a 1:1 ratio to transcatheter aortic valve replacement with the self-expanding transcatheter valve (transcatheter aortic valve replacement [TAVR] group) or to aortic valve replacement with a surgical bioprosthesis (surgical group). The 2-year clinical and echocardiographic outcomes were evaluated in these patients.
  
  
  RESULTS
  A total of 797 patients underwent randomization at 45 centers in the United States. The rate of 2-year all-cause mortality was significantly lower in the TAVR group (22.2%) than in the surgical group (28.6%; log-rank test p < 0.05) in the as-treated cohort, with an absolute reduction in risk of 6.5 percentage points. Similar results were found in the intention-to-treat cohort (log-rank test p < 0.05). The rate of 2-year death or major stroke was significantly lower in the TAVR group (24.2%) than in the surgical group (32.5%; log-rank test p = 0.01).
  
  
  CONCLUSIONS
  In patients with severe aortic stenosis who are at increased surgical risk, the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).
authors.affiliation: Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas. Electronic address: mreardon@houstonmethodist.org.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Reardon
authors.affiliation: Mount Sinai Health System, New York, New York.
authors.forename: David H
authors.initials: DH
authors.lastname: Adams
authors.affiliation: Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas.
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
authors.affiliation: Riverside Methodist Hospital, Columbus, Ohio.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Yakubov
authors.affiliation: Texas Heart Institute at St. Luke's Medical Center, Houston, Texas.
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Coselli
authors.affiliation: University of Michigan Medical Center, Ann Arbor, Michigan.
authors.forename: G Michael
authors.initials: GM
authors.lastname: Deeb
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Gleason
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Joon Sup
authors.initials: JS
authors.lastname: Lee
authors.affiliation: St. Vincent Medical Center, Indianapolis, Indiana.
authors.forename: James B
authors.initials: JB
authors.lastname: Hermiller
authors.affiliation: University of Michigan Medical Center, Ann Arbor, Michigan.
authors.forename: Stan
authors.initials: S
authors.lastname: Chetcuti
authors.affiliation: Spectrum Health System, Grand Rapids, Michigan.
authors.forename: John
authors.initials: J
authors.lastname: Heiser
authors.affiliation: Spectrum Health System, Grand Rapids, Michigan.
authors.forename: William
authors.initials: W
authors.lastname: Merhi
authors.affiliation: The University of Kansas Hospital, Kansas City, Kansas.
authors.forename: George L
authors.initials: GL
authors.lastname: Zorn
authors.affiliation: The University of Kansas Hospital, Kansas City, Kansas.
authors.forename: Peter
authors.initials: P
authors.lastname: Tadros
authors.affiliation: St. Francis Hospital, Roslyn, New York.
authors.forename: Newell
authors.initials: N
authors.lastname: Robinson
authors.affiliation: St. Francis Hospital, Roslyn, New York.
authors.forename: George
authors.initials: G
authors.lastname: Petrossian
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: G Chad
authors.initials: GC
authors.lastname: Hughes
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: J Kevin
authors.initials: JK
authors.lastname: Harrison
authors.affiliation: PinnacleHealth, Wormleysburg, Pennsylvania.
authors.forename: Brijeshwar
authors.initials: B
authors.lastname: Maini
authors.affiliation: PinnacleHealth, Wormleysburg, Pennsylvania.
authors.forename: Mubashir
authors.initials: M
authors.lastname: Mumtaz
authors.affiliation: The Johns Hopkins Hospital, Baltimore, Maryland.
authors.forename: John V
authors.initials: JV
authors.lastname: Conte
authors.affiliation: The Johns Hopkins Hospital, Baltimore, Maryland.
authors.forename: Jon R
authors.initials: JR
authors.lastname: Resar
authors.affiliation: Kaiser Permanente-Los Angeles Medical Center, Los Angeles, California.
authors.forename: Vicken
authors.initials: V
authors.lastname: Aharonian
authors.affiliation: Kaiser Permanente-Los Angeles Medical Center, Los Angeles, California.
authors.forename: Thomas
authors.initials: T
authors.lastname: Pfeffer
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: Jae K
authors.initials: JK
authors.lastname: Oh
authors.affiliation: Medtronic, Inc., Minneapolis, Minnesota.
authors.forename: Hongyan
authors.initials: H
authors.lastname: Qiao
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D001705:Bioprosthesis; D006328:Cardiac Catheterization; D004452:Echocardiography; D005260:Female; D006801:Humans; D008297:Male; D020521:Stroke / Q000209:etiology; D016896:Treatment Outcome
keywords: TAVR; aortic stenosis; outcomes