MedStar Authors catalog › Details for: 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.
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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.

by Pichard, Augusto D.
Citation: Lancet. 385(9986):2477-84, 2015 Jun 20..Journal: Lancet (London, England).ISSN: 0140-6736.Full author list: Mack MJ; Leon MB; Smith CR; Miller DC; Moses JW; Tuzcu EM; Webb JG; Douglas PS; Anderson WN; Blackstone EH; Kodali SK; Makkar RR; Fontana GP; Kapadia S; Bavaria J; Hahn RT; Thourani VH; Babaliaros V; Pichard A; Herrmann HC; Brown DL; Williams M; Akin J; Davidson MJ; Svensson LG; PARTNER 1 trial investigators.UI/PMID: 25788234.Subject(s): Aged | Aged, 80 and over | Aortic Valve/su [Surgery] | Aortic Valve Insufficiency/ep [Epidemiology] | Aortic Valve Stenosis/ep [Epidemiology] | *Aortic Valve Stenosis/su [Surgery] | Canada | Cause of Death | Comorbidity | Female | Follow-Up Studies | Germany | *Heart Valve Prosthesis Implantation/mt [Methods] | Heart Valve Prosthesis Implantation/mo [Mortality] | Humans | Male | Survival Analysis | Survival Rate | *Transcatheter Aortic Valve Replacement/mt [Methods] | *Transcatheter Aortic Valve Replacement/mo [Mortality] | Treatment Outcome | United StatesInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Comparative Study | Journal Article | Multicenter Study | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tOnline resources: Click here to access online Digital Object Identifier: http://dx.doi.org/10.1016/S0140-6736(15)60308-7 (Click here) Abbreviated citation: Lancet. 385(9986):2477-84, 2015 Jun 20.Local Holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1983 - 2007.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.Abstract: 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.Abstract: 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).Abstract: INTERPRETATION: Our findings show that TAVR as an alternative to surgery for patients with high surgical risk results in similar clinical outcomes.Abstract: FUNDING: Edwards Lifesciences.Copyright � 2015 Elsevier Ltd. All rights reserved.

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