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Lancet. 2015 Jun 20;385(9986):2477-84. doi: 10.1016/S0140-6736(15)60308-7. Epub 2015 Mar 15.

5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial.

Author information

1
Baylor Scott & White Health, Plano, TX, USA. Electronic address: michael.mack@baylorhealth.edu.
2
Columbia University Medical Center/New York Presbyterian Hospital, New York, NY, USA.
3
Stanford University School of Medicine, Department of Cardiovascular Surgery, Falk CV Research Center, Stanford, CA, USA.
4
Cleveland Clinic, Cleveland, OH, USA.
5
St Paul's Hospital, Vancouver, BC, Canada.
6
Duke Clinical Research Institute/Duke University Medical Center, Durham, NC, USA.
7
independent consultant, Lake Forest, CA, USA.
8
Cedars Sinai Medical Center, Los Angeles, CA, USA.
9
Lenox Hill Hospital, New York, NY, USA.
10
University of Pennsylvania, Philadelphia, PA, USA.
11
Emory University School of Medicine, Atlanta, GA, USA.
12
Medstar Washington Hospital Center, Washington, DC, USA.
13
Heart Hospital, Plano, TX, USA.
14
NYU Langone Medical Center, New York, NY, USA.
15
Brigham and Women's Hospital, Boston, MA, USA.

Abstract

BACKGROUND:

The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that mortality at 1 year, 2 years, and 3 years is much the same with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for high-risk patients with aortic stenosis. We report here the 5-year outcomes.

METHODS:

We did this randomised controlled trial at 25 hospitals, in Canada (two), Germany (one), and the USA (23). We used a computer-generated randomisation sequence to randomly assign high-risk patients with severe aortic stenosis to either SAVR or TAVR with a balloon-expandable bovine pericardial tissue valve by either a transfemoral or transapical approach. Patients and their treating physicians were not masked to treatment allocation. The primary outcome of the trial was all-cause mortality in the intention-to-treat population at 1 year, we present here predefined outcomes at 5 years. The study is registered with ClinicalTrials.gov, number NCT00530894.

FINDINGS:

We screened 3105 patients, of whom 699 were enrolled (348 assigned to TAVR, 351 assigned to SAVR). Overall mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 11·7%. At 5 years, risk of death was 67·8% in the TAVR group compared with 62·4% in the SAVR group (hazard ratio 1·04, 95% CI 0·86-1·24; p=0·76). We recorded no structural valve deterioration requiring surgical valve replacement in either group. Moderate or severe aortic regurgitation occurred in 40 (14%) of 280 patients in the TAVR group and two (1%) of 228 in the SAVR group (p<0·0001), and was associated with increased 5-year risk of mortality in the TAVR group (72·4% for moderate or severe aortic regurgitation vs 56·6% for those with mild aortic regurgitation or less; p=0·003).

INTERPRETATION:

Our findings show that TAVR as an alternative to surgery for patients with high surgical risk results in similar clinical outcomes.

FUNDING:

Edwards Lifesciences.

PMID:
25788234
DOI:
10.1016/S0140-6736(15)60308-7
[Indexed for MEDLINE]

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