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.
Citation: Lancet. 385(9986):2477-84, 2015 Jun 20.PMID: 25788234Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Comparative Study | Journal Article | Multicenter Study | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tSubject headings: *Aortic Valve Stenosis/su [Surgery] | *Heart Valve Prosthesis Implantation/mt [Methods] | *Transcatheter Aortic Valve Replacement/mo [Mortality] | *Transcatheter Aortic Valve Replacement/mt [Methods] | Aged | Aged, 80 and over | Aortic Valve Insufficiency/ep [Epidemiology] | Aortic Valve Stenosis/ep [Epidemiology] | Aortic Valve/su [Surgery] | Canada | Cause of Death | Comorbidity | Female | Follow-Up Studies | Germany | Heart Valve Prosthesis Implantation/mo [Mortality] | Humans | Male | Survival Analysis | Survival Rate | Treatment Outcome | United StatesLocal holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1983 - 2007ISSN:- 0140-6736
Item type | Current library | Collection | Call number | Status | Date due | Barcode |
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Journal Article | MedStar Authors Catalog | Article | Available | 25788234 |
Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1983 - 2007
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.
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