title: Outcomes after transfemoral transcatheter aortic valve replacement: a comparison of the randomized PARTNER (Placement of AoRTic TraNscathetER Valves) trial with the NRCA (Nonrandomized Continued Access) registry.
abstract: OBJECTIVE
  This study sought to determine whether outcomes for transfemoral (TF) transcatheter aortic valve replacement (TAVR) differ between the randomized controlled trial (RCT) and the subsequent NRCA (Nonrandomized Continued Access) registry of the PARTNER (Placement of AoRTic TraNscathetER Valves) trial.
  
  
  BACKGROUND
  The PARTNER RCT demonstrated that TAVR with the Edwards Sapien valve (Edwards Lifesciences, Irvine, California) is noninferior to surgery in high-risk patients and superior to standard therapy for inoperable patients.
  
  
  METHODS
  The inclusion and exclusion criteria, data collection, monitoring, and core laboratories were the same for the RCT and NRCA registry. Baseline characteristics, procedural results, and 1-year outcomes were compared between patients undergoing TF-TAVR as part of the RCT and as part of the NRCA registry.
  
  
  RESULTS
  In the RCT, 415 patients underwent TF-TAVR, whereas in the NRCA, 1,023 patients did. At 30 days, death, cardiac death, stroke, and transient ischemic attacks were not different in the NRCA registry than in the RCT. Major vascular complications (8.0% vs. 15.7%, p < 0.0001) and major bleeding (6.8% vs. 15.3%, p < 0.0001) were significantly lower in the NRCA registry. At 1 year, death rates were significantly lower in the NRCA cohort (19.0% vs. 25.3%, p = 0.009) and cardiac death tended to be lower (8.4% vs. 11.1%, p = 0.12). Stroke or transient ischemic attack (6.2% vs. 8.7%, p = 0.10) and stroke alone (5.0% vs. 7.1%, p = 0.13) also tended to be lower.
  
  
  CONCLUSIONS
  The large NRCA registry demonstrates further improvement in procedural and longer-term outcomes after TF-TAVR when compared with the favorable results from the PARTNER RCT. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).
authors.affiliation: Stanford University School of Medicine, Stanford, California. Electronic address: wfearon@stanford.edu.
authors.forename: William F
authors.initials: WF
authors.lastname: Fearon
authors.affiliation: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
authors.forename: Susheel
authors.initials: S
authors.lastname: Kodali
authors.affiliation: Columbia University Medical Center/New York Presbyterian Hospital, New York, New York.
authors.forename: Darshan
authors.initials: D
authors.lastname: Doshi
authors.affiliation: Stanford University School of Medicine, Stanford, California.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Fischbein
authors.affiliation: Stanford University School of Medicine, Stanford, California.
authors.forename: Alan C
authors.initials: AC
authors.lastname: Yeung
authors.affiliation: Cleveland Clinic Foundation, Cleveland, Ohio.
authors.forename: E Murat
authors.initials: EM
authors.lastname: Tuzcu
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: Charanjit S
authors.initials: CS
authors.lastname: Rihal
authors.affiliation: Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Vasilis
authors.initials: V
authors.lastname: Babaliaros
authors.affiliation: Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Alan
authors.initials: A
authors.lastname: Zajarias
authors.affiliation: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Howard C
authors.initials: HC
authors.lastname: Herrmann
authors.affiliation: Baylor Healthcare System, Plano, Texas.
authors.forename: David L
authors.initials: DL
authors.lastname: Brown
authors.affiliation: Baylor Scott & White Health, Plano, Texas.
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.affiliation: Scripps Clinic, La Jolla, California.
authors.forename: Paul S
authors.initials: PS
authors.lastname: Teirstein
authors.affiliation: Intermountain Medical Center, Salt Lake City, Utah.
authors.forename: Brian K
authors.initials: BK
authors.lastname: Whisenant
authors.affiliation: Cedars Sinai Medical Center, Los Angeles, California.
authors.forename: Raj
authors.initials: R
authors.lastname: Makkar
authors.affiliation: Cleveland Clinic Foundation, Cleveland, Ohio.
authors.forename: Samir
authors.initials: S
authors.lastname: Kapadia
authors.affiliation: Stanford University School of Medicine, Stanford, California.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D005260:Female; D005263:Femoral Artery; D006331:Heart Diseases / Q000209:etiology / Q000401:mortality; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D006470:Hemorrhage / Q000209:etiology / Q000401:mortality; D006801:Humans; D002546:Ischemic Attack, Transient / Q000209:etiology / Q000401:mortality; D053208:Kaplan-Meier Estimate; D008297:Male; D011474:Prosthesis Design; D012042:Registries; D012307:Risk Factors; D020521:Stroke / Q000209:etiology / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
keywords: aortic stenosis; transcatheter aortic valve implantation; transcatheter aortic valve replacement; transfemoral