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

Abstract

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).

• Authors: Michael J Reardon, David H Adams, Neal S Kleiman, Steven J Yakubov, Joseph S Coselli, G Michael Deeb, Thomas G Gleason, Joon Sup Lee, James B Hermiller Jr, Stan Chetcuti, John Heiser, William Merhi, George L Zorn 3rd, Peter Tadros, Newell Robinson, George Petrossian, G Chad Hughes, J Kevin Harrison, Brijeshwar Maini, Mubashir Mumtaz, John V Conte, Jon R Resar, Vicken Aharonian, Thomas Pfeffer, Jae K Oh, Hongyan Qiao, Jeffrey J Popma
• Journal: Journal of the American College of Cardiology (J Am Coll Cardiol) Vol. 66 Issue 2 Pg. 113-21 (Jul 14 2015) ISSN: 1558-3597 [Electronic] United States
• PMID: 26055947 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Topics

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