title: A Randomized Evaluation of the SAPIEN XT Transcatheter Heart Valve System in Patients With Aortic Stenosis Who Are Not Candidates for Surgery.
abstract: OBJECTIVE
  The purpose of this study was to determine the safety and effectiveness of the SAPIEN XT versus SAPIEN systems (Edwards Lifesciences, Irvine, California) in patients with symptomatic, severe aortic stenosis (AS) who were not candidates for surgery.
  
  
  BACKGROUND
  Transcatheter aortic valve replacement (TAVR) has become the standard of care for inoperable patients with severe, symptomatic AS. In the PARTNER (Placement of Aortic Transcatheter Valves) IB trial, a reduction in all-cause mortality was observed in patients undergoing TAVR with the balloon-expandable SAPIEN transcatheter heart valve compared with standard therapy, but the SAPIEN valve was associated with adverse periprocedural complications, including vascular complications, major bleeding, and paravalvular regurgitation. The newer, low-profile SAPIEN XT system was developed to reduce these adverse events.
  
  
  METHODS
  A total of 560 patients were enrolled at 28 sites in the United States from April 2011 to February 2012. Patients were randomized to receive the SAPIEN or SAPIEN XT systems. The primary endpoint was a nonhierarchical composite of all-cause mortality, major stroke, and rehospitalization at 1 year in the intention-to-treat population, assessed by noninferiority testing. Pre-specified secondary endpoints included cardiovascular death, New York Heart Association functional class, myocardial infarction, stroke, acute kidney injury, vascular complications, bleeding, 6-min walk distance, and valve performance (by echocardiography).
  
  
  RESULTS
  Both overall and major vascular complications were higher at 30 days in patients undergoing TAVR with SAPIEN compared with SAPIEN XT (overall: 22.1% vs. 15.5%; p = 0.04; major: 15.2% vs. 9.5%; p = 0.04). Bleeding requiring blood transfusions was also more frequent with SAPIEN compared with SAPIEN XT (10.6% vs. 5.3%; p = 0.02). At 1-year follow-up, the nonhierarchical composite of all-cause mortality, major stroke, or rehospitalization was similar (37.7% SAPIEN vs. 37.2% SAPIEN XT; noninferiority p value <0.002); no differences in the other major pre-specified endpoints were found.
  
  
  CONCLUSIONS
  In inoperable patients with severe, symptomatic AS, the lower-profile SAPIEN XT is noninferior to SAPIEN with fewer vascular complications and a lesser need for blood transfusion. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves; NCT01314313).
authors.affiliation: St. Paul's Hospital, Vancouver, British Columbia, Canada. Electronic address: john.webb@vch.ca.
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.affiliation: Columbia University Medical Center, New York, New York.
authors.forename: Darshan
authors.initials: D
authors.lastname: Doshi
authors.affiliation: Baylor Scott & White Health, Plano, Texas.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mack
authors.affiliation: Cedars Sinai Medical Center, Los Angeles, California.
authors.forename: Raj
authors.initials: R
authors.lastname: Makkar
authors.affiliation: Columbia University Medical Center, New York, New York.
authors.forename: Craig R
authors.initials: CR
authors.lastname: Smith
authors.affiliation: Medstar Washington Hospital Center, Washington, DC.
authors.forename: Augusto D
authors.initials: AD
authors.lastname: Pichard
authors.affiliation: Columbia University Medical Center, New York, New York.
authors.forename: Susheel
authors.initials: S
authors.lastname: Kodali
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: Samir
authors.initials: S
authors.lastname: Kapadia
authors.affiliation: Stanford University, Stanford, California.
authors.forename: D Craig
authors.initials: DC
authors.lastname: Miller
authors.affiliation: Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Vasilis
authors.initials: V
authors.lastname: Babaliaros
authors.affiliation: Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Vinod
authors.initials: V
authors.lastname: Thourani
authors.affiliation: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Howard C
authors.initials: HC
authors.lastname: Herrmann
authors.affiliation: Oklahoma Heart Hospital, Oklahoma City, Oklahoma.
authors.forename: Mark
authors.initials: M
authors.lastname: Bodenhamer
authors.affiliation: Intermountain Medical Center, Salt Lake City, Utah.
authors.forename: Brian K
authors.initials: BK
authors.lastname: Whisenant
authors.affiliation: Ochsner Clinic, New Orleans, Louisiana.
authors.forename: Stephen
authors.initials: S
authors.lastname: Ramee
authors.affiliation: Washington University School of Medicine, Saint Louis, Missouri.
authors.forename: Hersh
authors.initials: H
authors.lastname: Maniar
authors.affiliation: The Christ Hospital, Cincinnati, Ohio.
authors.forename: Dean
authors.initials: D
authors.lastname: Kereiakes
authors.affiliation: Cardiovascular Research Foundation, New York, New York.
authors.forename: Ke
authors.initials: K
authors.lastname: Xu
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: Wael A
authors.initials: WA
authors.lastname: Jaber
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: Venu
authors.initials: V
authors.lastname: Menon
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: E Murat
authors.initials: EM
authors.lastname: Tuzcu
authors.affiliation: St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: David
authors.initials: D
authors.lastname: Wood
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: Lars G
authors.initials: LG
authors.lastname: Svensson
authors.affiliation: Columbia University Medical Center, New York, New York.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D001955:British Columbia / Q000453:epidemiology; D003952:Diagnostic Imaging; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D018579:Patient Selection; D012189:Retrospective Studies; D012720:Severity of Illness Index; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation*; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
keywords: SAPIEN XT; TAVR; aortic stenosis; inoperable; transcatheter aortic valve replacement