title: Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis.
abstract: BACKGROUND
  Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve demonstrates good 30 day clinical outcomes in patients with severe aortic stenosis who are at intermediate risk of surgical mortality. Here we report longer-term data in intermediate-risk patients given SAPIEN 3 TAVR and compare outcomes to those of intermediate-risk patients given surgical aortic valve replacement.
  
  
  METHODS
  In the SAPIEN 3 observational study, 1077 intermediate-risk patients at 51 sites in the USA and Canada were assigned to receive TAVR with the SAPIEN 3 valve [952 [88%] via transfemoral access) between Feb 17, 2014, and Sept 3, 2014. In this population we assessed all-cause mortality and incidence of strokes, re-intervention, and aortic valve regurgitation at 1 year after implantation. Then we compared 1 year outcomes in this population with those for intermediate-risk patients treated with surgical valve replacement in the PARTNER 2A trial between Dec 23, 2011, and Nov 6, 2013, using a prespecified propensity score analysis to account for between-trial differences in baseline characteristics. The clinical events committee and echocardiographic core laboratory methods were the same for both studies. The primary endpoint was the composite of death from any cause, all strokes, and incidence of moderate or severe aortic regurgitation. We did non-inferiority (margin 7·5%) and superiority analyses in propensity score quintiles to calculate pooled weighted proportion differences for outcomes.
  
  
  RESULTS
  At 1 year follow-up of the SAPIEN 3 observational study, 79 of 1077 patients who initiated the TAVR procedure had died (all-cause mortality 7·4%; 6·5% in the transfemoral access subgroup), and disabling strokes had occurred in 24 (2%), aortic valve re-intervention in six (1%), and moderate or severe paravalvular regurgitation in 13 (2%). In the propensity-score analysis we included 963 patients treated with SAPIEN 3 TAVR and 747 with surgical valve replacement. For the primary composite endpoint of mortality, strokes, and moderate or severe aortic regurgitation, TAVR was both non-inferior (pooled weighted proportion difference of -9·2%; 90% CI -12·4 to -6; p<0·0001) and superior (-9·2%, 95% CI -13·0 to -5·4; p<0·0001) to surgical valve replacement.
  
  
  CONCLUSIONS
  TAVR with SAPIEN 3 in intermediate-risk patients with severe aortic stenosis is associated with low mortality, strokes, and regurgitation at 1 year. The propensity score analysis indicates a significant superiority for our composite outcome with TAVR compared with surgery, suggesting that TAVR might be the preferred treatment alternative in intermediate-risk patients.
  
  
  BACKGROUND
  None.
authors.affiliation: Emory University School of Medicine, Atlanta, GA, USA. Electronic address: vthoura@emory.edu.
authors.forename: Vinod H
authors.initials: VH
authors.lastname: Thourani
authors.affiliation: Columbia University Medical Center, New York, NY, USA.
authors.forename: Susheel
authors.initials: S
authors.lastname: Kodali
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, CA, USA.
authors.forename: Raj R
authors.initials: RR
authors.lastname: Makkar
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Howard C
authors.initials: HC
authors.lastname: Herrmann
authors.affiliation: NYU Langone Medical Center, New York, NY, USA.
authors.forename: Mathew
authors.initials: M
authors.lastname: Williams
authors.affiliation: Emory University School of Medicine, Atlanta, GA, USA.
authors.forename: Vasilis
authors.initials: V
authors.lastname: Babaliaros
authors.affiliation: University of Texas Memorial Hermann Heart and Vascular Institute, Houston, TX, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Smalling
authors.affiliation: University of Virginia, Charlottesville, VA, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Lim
authors.affiliation: Northwestern University, Chicago, IL, USA.
authors.forename: S Chris
authors.initials: SC
authors.lastname: Malaisrie
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Samir
authors.initials: S
authors.lastname: Kapadia
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Wilson Y
authors.initials: WY
authors.lastname: Szeto
authors.affiliation: Mayo Clinic, Rochester, MN, USA.
authors.forename: Kevin L
authors.initials: KL
authors.lastname: Greason
authors.affiliation: The Christ Hospital, Cincinnati, OH, USA.
authors.forename: Dean
authors.initials: D
authors.lastname: Kereiakes
authors.affiliation: University of Virginia, Charlottesville, VA, USA.
authors.forename: Gorav
authors.initials: G
authors.lastname: Ailawadi
authors.affiliation: Intermountain Medical Center, Salt Lake City, UT, USA.
authors.forename: Brian K
authors.initials: BK
authors.lastname: Whisenant
authors.affiliation: Emory University School of Medicine, Atlanta, GA, USA.
authors.forename: Chandan
authors.initials: C
authors.lastname: Devireddy
authors.affiliation: St Paul's Hospital, Vancouver, BC, Canada.
authors.forename: Jonathon
authors.initials: J
authors.lastname: Leipsic
authors.affiliation: Columbia University Medical Center, New York, NY, USA.
authors.forename: Rebecca T
authors.initials: RT
authors.lastname: Hahn
authors.affiliation: Laval University, Quebec, QC, Canada.
authors.forename: Philippe
authors.initials: P
authors.lastname: Pibarot
authors.affiliation: Medstar Health Research Institute and Georgetown University, Washington, DC, USA.
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Weissman
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Wael A
authors.initials: WA
authors.lastname: Jaber
authors.affiliation: Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Rakesh
authors.initials: R
authors.lastname: Suri
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: E Murat
authors.initials: EM
authors.lastname: Tuzcu
authors.affiliation: Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Lars G
authors.initials: LG
authors.lastname: Svensson
authors.affiliation: St Paul's Hospital, Vancouver, BC, Canada.
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.affiliation: Columbia University Medical Center, New York, NY, USA.
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.affiliation: Baylor Scott and White Healthcare, Plano, TX, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mack
authors.affiliation: Stanford University, Stanford, CA, USA.
authors.forename: D Craig
authors.initials: DC
authors.lastname: Miller
authors.affiliation: Columbia University Medical Center, New York, NY, USA.
authors.forename: Craig R
authors.initials: CR
authors.lastname: Smith
authors.affiliation: Columbia University Medical Center, New York, NY, USA.
authors.forename: Maria C
authors.initials: MC
authors.lastname: Alu
authors.affiliation: Cardiovascular Research Foundation, New York, NY, USA.
authors.forename: Rupa
authors.initials: R
authors.lastname: Parvataneni
authors.affiliation: Wake Forest School of Medicine, Winston-Salem, NC, USA.
authors.forename: Ralph B
authors.initials: RB
authors.lastname: D'Agostino
authors.affiliation: Columbia University Medical Center, New York, NY, USA.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D001021:Aortic Valve / Q000601:surgery; D001022:Aortic Valve Insufficiency / Q000401:mortality / Q000601:surgery; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods / Q000401:mortality; D007902:Length of Stay; D057216:Propensity Score; D012307:Risk Factors; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods / Q000401:mortality; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D064887:Observational Studies as Topic