title: 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial.
abstract: BACKGROUND
  The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that mortality at 1 year, 2 years, and 3 years is much the same with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for high-risk patients with aortic stenosis. We report here the 5-year outcomes.
  
  
  METHODS
  We did this randomised controlled trial at 25 hospitals, in Canada (two), Germany (one), and the USA (23). We used a computer-generated randomisation sequence to randomly assign high-risk patients with severe aortic stenosis to either SAVR or TAVR with a balloon-expandable bovine pericardial tissue valve by either a transfemoral or transapical approach. Patients and their treating physicians were not masked to treatment allocation. The primary outcome of the trial was all-cause mortality in the intention-to-treat population at 1 year, we present here predefined outcomes at 5 years. The study is registered with ClinicalTrials.gov, number NCT00530894.
  
  
  RESULTS
  We screened 3105 patients, of whom 699 were enrolled (348 assigned to TAVR, 351 assigned to SAVR). Overall mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 11·7%. At 5 years, risk of death was 67·8% in the TAVR group compared with 62·4% in the SAVR group (hazard ratio 1·04, 95% CI 0·86-1·24; p=0·76). We recorded no structural valve deterioration requiring surgical valve replacement in either group. Moderate or severe aortic regurgitation occurred in 40 (14%) of 280 patients in the TAVR group and two (1%) of 228 in the SAVR group (p<0·0001), and was associated with increased 5-year risk of mortality in the TAVR group (72·4% for moderate or severe aortic regurgitation vs 56·6% for those with mild aortic regurgitation or less; p=0·003).
  
  
  CONCLUSIONS
  Our findings show that TAVR as an alternative to surgery for patients with high surgical risk results in similar clinical outcomes.
  
  
  BACKGROUND
  Edwards Lifesciences.
authors: Baylor Scott & White Health, Plano, TX, USA. Electronic address: michael.mack@baylorhealth.edu.
authors: Michael J
authors: MJ
authors: Mack
authors: Columbia University Medical Center/New York Presbyterian Hospital, New York, NY, USA.
authors: Martin B
authors: MB
authors: Leon
authors: Columbia University Medical Center/New York Presbyterian Hospital, New York, NY, USA.
authors: Craig R
authors: CR
authors: Smith
authors: Stanford University School of Medicine, Department of Cardiovascular Surgery, Falk CV Research Center, Stanford, CA, USA.
authors: D Craig
authors: DC
authors: Miller
authors: Columbia University Medical Center/New York Presbyterian Hospital, New York, NY, USA.
authors: Jeffrey W
authors: JW
authors: Moses
authors: Cleveland Clinic, Cleveland, OH, USA.
authors: E Murat
authors: EM
authors: Tuzcu
authors: St Paul's Hospital, Vancouver, BC, Canada.
authors: John G
authors: JG
authors: Webb
authors: Duke Clinical Research Institute/Duke University Medical Center, Durham, NC, USA.
authors: Pamela S
authors: PS
authors: Douglas
authors: independent consultant, Lake Forest, CA, USA.
authors: William N
authors: WN
authors: Anderson
authors: Cleveland Clinic, Cleveland, OH, USA.
authors: Eugene H
authors: EH
authors: Blackstone
authors: Columbia University Medical Center/New York Presbyterian Hospital, New York, NY, USA.
authors: Susheel K
authors: SK
authors: Kodali
authors: Cedars Sinai Medical Center, Los Angeles, CA, USA.
authors: Raj R
authors: RR
authors: Makkar
authors: Lenox Hill Hospital, New York, NY, USA.
authors: Gregory P
authors: GP
authors: Fontana
authors: Cleveland Clinic, Cleveland, OH, USA.
authors: Samir
authors: S
authors: Kapadia
authors: University of Pennsylvania, Philadelphia, PA, USA.
authors: Joseph
authors: J
authors: Bavaria
authors: Columbia University Medical Center/New York Presbyterian Hospital, New York, NY, USA.
authors: Rebecca T
authors: RT
authors: Hahn
authors: Emory University School of Medicine, Atlanta, GA, USA.
authors: Vinod H
authors: VH
authors: Thourani
authors: Emory University School of Medicine, Atlanta, GA, USA.
authors: Vasilis
authors: V
authors: Babaliaros
authors: Medstar Washington Hospital Center, Washington, DC, USA.
authors: Augusto
authors: A
authors: Pichard
authors: University of Pennsylvania, Philadelphia, PA, USA.
authors: Howard C
authors: HC
authors: Herrmann
authors: Heart Hospital, Plano, TX, USA.
authors: David L
authors: DL
authors: Brown
authors: NYU Langone Medical Center, New York, NY, USA.
authors: Mathew
authors: M
authors: Williams
authors: Jodi
authors: J
authors: Akin
authors: Brigham and Women's Hospital, Boston, MA, USA.
authors: Michael J
authors: MJ
authors: Davidson
authors: Cleveland Clinic, Cleveland, OH, USA.
authors: Lars G
authors: LG
authors: Svensson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery; D001022:Aortic Valve Insufficiency / Q000453:epidemiology; D001024:Aortic Valve Stenosis / Q000453:epidemiology / Q000601:surgery*; D002170:Canada; D002423:Cause of Death; D015897:Comorbidity; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D019918:Heart Valve Prosthesis Implantation / Q000379:methods* / Q000401:mortality; D006801:Humans; D008297:Male; D016019:Survival Analysis; D015996:Survival Rate; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods* / Q000401:mortality*; D016896:Treatment Outcome; D014481:United States