title: Outcomes in the Randomized CoreValve US Pivotal High Risk Trial in Patients With a Society of Thoracic Surgeons Risk Score of 7% or Less.
abstract: Transcatheter aortic valve replacement (TAVR) is now a well-accepted alternative to surgical AVR (SAVR) for patients with symptomatic aortic stenosis at increased operative risk. There is interest in whether TAVR would benefit patients at lower risk.
  
  
  
  The Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) has trended downward in US TAVR trials and the STS/American College of Cardiology Transcatheter Valve Therapy Registry. We hypothesized that if the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) alone is sufficient to define decreased risk, the contribution to survival based on the degree of invasiveness of the TAVR procedure will decrease, making it more difficult to show improved survival and benefit over SAVR.
  
  
  
  The CoreValve US Pivotal High Risk Trial was a multicenter, randomized, noninferiority trial. This retrospective analysis evaluated patients who underwent an attempted implant and had an STS PROM of 7% or less. The trial was performed at 45 US sites. Patients had severe aortic stenosis and were at increased surgical risk based on their STS PROM score and other risk factors.
  
  
  
  Eligible patients were randomly assigned (1:1) to self-expanding TAVR or to SAVR.
  
  
  
  We retrospectively stratified patients by the overall median STS PROM score (7%) and analyzed clinical outcomes and quality of life using the Kansas City Cardiomyopathy Questionnaire in patients with an STS PROM score of 7% or less.
  
  
  
  The mean (SD) ages were 81.5 (7.6) years for the TAVR group and 81.2 years (6.6) for the SAVR group. A little more than half were men (57.9% in the TAVR group and 55.8% in the SAVR group). Of 750 patients who underwent attempted implantation, 383 (202 TAVR and 181 SAVR) had an STS PROM of 7% or less (median [interquartile range]: TAVR, 5.3% [4.3%-6.1%]; SAVR, 5.3% [4.1%-5.9%]). Two-year all-cause mortality for TAVR vs SAVR was 15.0% (95% CI, 8.9-10.0) vs 26.3% (95% CI, 19.7-33.0) (log rank P = .01). The 2-year rate of stroke for TAVR vs SAVR was 11.3% vs 15.1% (log rank P = .50). Quality of life by the Kansas City Cardiomyopathy Questionnaire summary score showed significant and equivalent increases in both groups at 2 years (mean [SD] TAVR, 20.0 [25.0]; SAVR, 18.6 [23.6]; P = .71; both P < .001 compared with baseline). Medical benefit, defined as alive with a Kansas City Cardiomyopathy Questionnaire summary score of at least 60 and a less than 10-point decrease from baseline, was similar between groups at 2 years (TAVR, 51.0%; SAVR, 44.4%; P = .28).
  
  
  
  Self-expanding TAVR compares favorably with SAVR in high-risk patients with STS PROM scores traditionally considered intermediate risk.
  
  
  
  Clinicaltrials.gov Identifier: NCT01240902.
authors.affiliation: Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Reardon
authors.affiliation: Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
authors.affiliation: Mount Sinai Health System, New York, New York.
authors.forename: David H
authors.initials: DH
authors.lastname: Adams
authors.affiliation: Riverside Methodist Hospital, Columbus, Ohio.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Yakubov
authors.affiliation: Texas Heart Institute, CHI St. Luke's Health, Baylor St. Luke's Medical Center, Houston.
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Coselli
authors.affiliation: University of Michigan Medical Center, Ann Arbor.
authors.forename: G Michael
authors.initials: GM
authors.lastname: Deeb
authors.affiliation: St. Luke's Medical Center/Aurora Health Care, Milwaukee, Wisconsin.
authors.forename: Daniel
authors.initials: D
authors.lastname: O'Hair
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Gleason
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Joon Sup
authors.initials: JS
authors.lastname: Lee
authors.affiliation: St. Vincent Medical Center, Indianapolis, Indiana.
authors.forename: James B
authors.initials: JB
authors.lastname: Hermiller
authors.affiliation: University of Michigan Medical Center, Ann Arbor.
authors.forename: Stan
authors.initials: S
authors.lastname: Chetcuti
authors.affiliation: Spectrum Health Hospitals, Grand Rapids, Michigan.
authors.forename: John
authors.initials: J
authors.lastname: Heiser
authors.affiliation: Spectrum Health Hospitals, Grand Rapids, Michigan.
authors.forename: William
authors.initials: W
authors.lastname: Merhi
authors.affiliation: The University of Kansas Hospital, Kansas City.
authors.forename: George L
authors.initials: GL
authors.lastname: Zorn
authors.affiliation: The University of Kansas Hospital, Kansas City.
authors.forename: Peter
authors.initials: P
authors.lastname: Tadros
authors.affiliation: St. Francis Hospital, Roslyn, New York.
authors.forename: Newell
authors.initials: N
authors.lastname: Robinson
authors.affiliation: St. Francis Hospital, Roslyn, New York.
authors.forename: George
authors.initials: G
authors.lastname: Petrossian
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: G Chad
authors.initials: GC
authors.lastname: Hughes
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: J Kevin
authors.initials: JK
authors.lastname: Harrison
authors.affiliation: Pinnacle Health, Wormleysburg, Pennsylvania14Tenet Florida, Coral Springs, Florida.
authors.forename: Brijeshwar
authors.initials: B
authors.lastname: Maini
authors.affiliation: Pinnacle Health, Wormleysburg, Pennsylvania14Tenet Florida, Coral Springs, Florida.
authors.forename: Mubashir
authors.initials: M
authors.lastname: Mumtaz
authors.affiliation: Johns Hopkins Hospital, Baltimore, Maryland.
authors.forename: John V
authors.initials: JV
authors.lastname: Conte
authors.affiliation: Johns Hopkins Hospital, Baltimore, Maryland.
authors.forename: Jon R
authors.initials: JR
authors.lastname: Resar
authors.affiliation: Kaiser Permanente, Los Angeles Medical Center, Los Angeles, California.
authors.forename: Vicken
authors.initials: V
authors.lastname: Aharonian
authors.affiliation: Kaiser Permanente, Los Angeles Medical Center, Los Angeles, California.
authors.forename: Thomas
authors.initials: T
authors.lastname: Pfeffer
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: Jae K
authors.initials: JK
authors.lastname: Oh
authors.affiliation: Medtronic, Minneapolis, Minnesota.
authors.forename: Jian
authors.initials: J
authors.lastname: Huang
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000628:therapy*; D005260:Female; D019918:Heart Valve Prosthesis Implantation; D006801:Humans; D008297:Male; D011788:Quality of Life; D012189:Retrospective Studies; D012306:Risk; D066231:Surgeons; D065467:Transcatheter Aortic Valve Replacement; D016896:Treatment Outcome