2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement.

Journal Article (Journal Article;Multicenter Study)

BACKGROUND: The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery, the 1-year survival rate was 4.9 percentage points higher in patients treated with a self-expanding transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis. OBJECTIVES: Longer-term clinical outcomes were examined to confirm if this mortality benefit is sustained. METHODS: Patients with severe aortic stenosis who were at increased surgical risk were recruited. Eligible patients were randomly assigned in a 1:1 ratio to transcatheter aortic valve replacement with the self-expanding transcatheter valve (transcatheter aortic valve replacement [TAVR] group) or to aortic valve replacement with a surgical bioprosthesis (surgical group). The 2-year clinical and echocardiographic outcomes were evaluated in these patients. RESULTS: A total of 797 patients underwent randomization at 45 centers in the United States. The rate of 2-year all-cause mortality was significantly lower in the TAVR group (22.2%) than in the surgical group (28.6%; log-rank test p < 0.05) in the as-treated cohort, with an absolute reduction in risk of 6.5 percentage points. Similar results were found in the intention-to-treat cohort (log-rank test p < 0.05). The rate of 2-year death or major stroke was significantly lower in the TAVR group (24.2%) than in the surgical group (32.5%; log-rank test p = 0.01). CONCLUSIONS: In patients with severe aortic stenosis who are at increased surgical risk, the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

Full Text

Duke Authors

Cited Authors

  • Reardon, MJ; Adams, DH; Kleiman, NS; Yakubov, SJ; Coselli, JS; Deeb, GM; Gleason, TG; Lee, JS; Hermiller, JB; Chetcuti, S; Heiser, J; Merhi, W; Zorn, GL; Tadros, P; Robinson, N; Petrossian, G; Hughes, GC; Harrison, JK; Maini, B; Mumtaz, M; Conte, JV; Resar, JR; Aharonian, V; Pfeffer, T; Oh, JK; Qiao, H; Popma, JJ

Published Date

  • July 14, 2015

Published In

Volume / Issue

  • 66 / 2

Start / End Page

  • 113 - 121

PubMed ID

  • 26055947

Electronic International Standard Serial Number (EISSN)

  • 1558-3597

Digital Object Identifier (DOI)

  • 10.1016/j.jacc.2015.05.017


  • eng

Conference Location

  • United States