TY  - BOOK
AU  - Pichard, Augusto D
TI  - 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
SN  - 0140-6736
KW  - *Aortic Valve Stenosis/su [Surgery]
KW  - *Heart Valve Prosthesis Implantation/mt [Methods]
KW  - *Transcatheter Aortic Valve Replacement/mo [Mortality]
KW  - *Transcatheter Aortic Valve Replacement/mt [Methods]
KW  - Aged
KW  - Aged, 80 and over
KW  - Aortic Valve Insufficiency/ep [Epidemiology]
KW  - Aortic Valve Stenosis/ep [Epidemiology]
KW  - Aortic Valve/su [Surgery]
KW  - Canada
KW  - Cause of Death
KW  - Comorbidity
KW  - Female
KW  - Follow-Up Studies
KW  - Germany
KW  - Heart Valve Prosthesis Implantation/mo [Mortality]
KW  - Humans
KW  - Male
KW  - Survival Analysis
KW  - Survival Rate
KW  - Treatment Outcome
KW  - United States
KW  - MedStar Heart & Vascular Institute
KW  - Comparative Study
KW  - Journal Article
KW  - Multicenter Study
KW  - Randomized Controlled Trial
KW  - Research Support, Non-U.S. Gov't
N1  - Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1983 - 2007
N2  - 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; 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 117%. At 5 years, risk of death was 678% in the TAVR group compared with 624% in the SAVR group (hazard ratio 104, 95% CI 086-124; p=076). 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<00001), and was associated with increased 5-year risk of mortality in the TAVR group (724% for moderate or severe aortic regurgitation vs 566% for those with mild aortic regurgitation or less; p=0003); FUNDING: Edwards Lifesciences.Copyright � 2015 Elsevier Ltd. All rights reserved; INTERPRETATION: Our findings show that TAVR as an alternative to surgery for patients with high surgical risk results in similar clinical 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
UR  - http://dx.doi.org/10.1016/S0140-6736(15)60308-7
ER  -