title: Transcatheter versus surgical aortic-valve replacement in high-risk patients.
abstract: BACKGROUND
  The use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not candidates for surgical replacement. However, the two procedures have not been compared in a randomized trial involving high-risk patients who are still candidates for surgical replacement.
  
  
  METHODS
  At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement.
  
  
  RESULTS
  The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P=0.07) and 24.2% and 26.8%, respectively, at 1 year (P=0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P=0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P=0.20) and 5.1% and 2.4%, respectively, at 1 year (P=0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P<0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, P=0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference.
  
  
  CONCLUSIONS
  In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks. (Funded by Edwards Lifesciences; Clinical Trials.gov number, NCT00530894.).
authors.affiliation: Columbia University Medical Center–New York Presbyterian Hospital, New York, NY 10032, USA. crs2@columbia.edu
authors.forename: Craig R
authors.initials: CR
authors.lastname: Smith
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mack
authors.forename: D Craig
authors.initials: DC
authors.lastname: Miller
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.forename: Lars G
authors.initials: LG
authors.lastname: Svensson
authors.forename: E Murat
authors.initials: EM
authors.lastname: Tuzcu
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.forename: Gregory P
authors.initials: GP
authors.lastname: Fontana
authors.forename: Raj R
authors.initials: RR
authors.lastname: Makkar
authors.forename: Mathew
authors.initials: M
authors.lastname: Williams
authors.forename: Todd
authors.initials: T
authors.lastname: Dewey
authors.forename: Samir
authors.initials: S
authors.lastname: Kapadia
authors.forename: Vasilis
authors.initials: V
authors.lastname: Babaliaros
authors.forename: Vinod H
authors.initials: VH
authors.lastname: Thourani
authors.forename: Paul
authors.initials: P
authors.lastname: Corso
authors.forename: Augusto D
authors.initials: AD
authors.lastname: Pichard
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Bavaria
authors.forename: Howard C
authors.initials: HC
authors.lastname: Herrmann
authors.forename: Jodi J
authors.initials: JJ
authors.lastname: Akin
authors.forename: William N
authors.initials: WN
authors.lastname: Anderson
authors.forename: Duolao
authors.initials: D
authors.lastname: Wang
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Pocock
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000401:mortality; D002404:Catheterization; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D011183:Postoperative Complications; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology / Q000209:etiology