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

J Am Coll Cardiol. 2015 Jul 14;66(2):113-21. doi: 10.1016/j.jacc.2015.05.017. Epub 2015 Jun 5.


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).

Keywords: TAVR; aortic stenosis; outcomes.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged, 80 and over
  • Aortic Valve
  • Aortic Valve Stenosis / mortality
  • Aortic Valve Stenosis / surgery
  • Aortic Valve Stenosis / therapy*
  • Bioprosthesis
  • Cardiac Catheterization
  • Echocardiography
  • Female
  • Humans
  • Male
  • Stroke / etiology
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT01240902