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

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

Author information

1
Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas. Electronic address: mreardon@houstonmethodist.org.
2
Mount Sinai Health System, New York, New York.
3
Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas.
4
Riverside Methodist Hospital, Columbus, Ohio.
5
Texas Heart Institute at St. Luke's Medical Center, Houston, Texas.
6
University of Michigan Medical Center, Ann Arbor, Michigan.
7
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
8
St. Vincent Medical Center, Indianapolis, Indiana.
9
Spectrum Health System, Grand Rapids, Michigan.
10
The University of Kansas Hospital, Kansas City, Kansas.
11
St. Francis Hospital, Roslyn, New York.
12
Duke University Medical Center, Durham, North Carolina.
13
PinnacleHealth, Wormleysburg, Pennsylvania.
14
The Johns Hopkins Hospital, Baltimore, Maryland.
15
Kaiser Permanente-Los Angeles Medical Center, Los Angeles, California.
16
Mayo Clinic, Rochester, Minnesota.
17
Medtronic, Inc., Minneapolis, Minnesota.
18
Beth Israel Deaconess Medical Center, Boston, Massachusetts.

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).

KEYWORDS:

TAVR; aortic stenosis; outcomes

PMID:
26055947
DOI:
10.1016/j.jacc.2015.05.017
[Indexed for MEDLINE]
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