MedStar Authors catalog › Details for: 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial.
Citation: Lancet. 385(9986):2485-91, 2015 Jun 20..Journal: Lancet (London, England).ISSN: 0140-6736.Full author list: Kapadia SR; Leon MB; Makkar RR; Tuzcu EM; Svensson LG; Kodali S; Webb JG; Mack MJ; Douglas PS; Thourani VH; Babaliaros VC; Herrmann HC; Szeto WY; Pichard AD; Williams MR; Fontana GP; Miller DC; Anderson WN; Akin JJ; Davidson MJ; Smith CR; PARTNER trial investigators.UI/PMID: 25788231.Subject(s): Aged | Aged, 80 and over | Aortic Valve/pp [Physiopathology] | Aortic Valve/su [Surgery] | Aortic Valve/us [Ultrasonography] | Aortic Valve Stenosis/ep [Epidemiology] | Aortic Valve Stenosis/pp [Physiopathology] | *Aortic Valve Stenosis/su [Surgery] | Aortic Valve Stenosis/us [Ultrasonography] | Canada | Cause of Death | Comorbidity | Echocardiography | Female | Follow-Up Studies | Germany | Hemodynamics | Humans | Kaplan-Meier Estimate | Male | Risk Assessment | Stroke/ep [Epidemiology] | Survival Rate | *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 onlineDigital Object Identifier: http://dx.doi.org/10.1016/S0140-6736(15)60290-2 (Click here)Abbreviated citation: Lancet. 385(9986):2485-91, 2015 Jun 20.Local Holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1983 - 2007.Abstract: BACKGROUND: Based on the early results of the Placement of Aortic Transcatheter Valves (PARTNER) trial, transcatheter aortic valve replacement (TAVR) is an accepted treatment for patients with severe aortic stenosis who are not suitable for surgery. However, little information is available about the late clinical outcomes in such patients.Abstract: METHODS: We did this randomised controlled trial at 21 experienced valve centres in Canada, Germany, and the USA. We enrolled patients with severe symptomatic inoperable aortic stenosis and randomly assigned (1:1) them to transfemoral TAVR or to standard treatment, which often included balloon aortic valvuloplasty. Patients and their treating physicians were not masked to treatment allocation. The randomisation was done centrally, and sites learned of the assignment only after a patient had been screened, consented, and entered into the database. The primary outcome of the trial was all-cause mortality at 1 year in the intention-to-treat population, here we present the prespecified findings after 5 years. This study is registered with ClinicalTrials.gov, number NCT00530894.Abstract: FINDINGS: We screened 3015 patients, of whom 358 were enrolled (mean age 83 years, Society of Thoracic Surgeons Predicted Risk of Mortality 117%, 54% female). 179 were assigned to TAVR treatment and 179 were assigned to standard treatment. 20 patients crossed over from the standard treatment group and ten withdrew from study, leaving only six patients at 5 years, of whom five had aortic valve replacement treatment outside of the study. The risk of all-cause mortality at 5 years was 718% in the TAVR group versus 936% in the standard treatment group (hazard ratio 050, 95% CI 039-065; p<00001). At 5 years, 42 (86%) of 49 survivors in the TAVR group had New York Heart Association class 1 or 2 symptoms compared with three (60%) of five in the standard treatment group. Echocardiography after TAVR showed durable haemodynamic benefit (aortic valve area 152 cm(2) at 5 years, mean gradient 106 mm Hg at 5 years), with no evidence of structural valve deterioration.Abstract: INTERPRETATION: TAVR is more beneficial than standard treatment for treatment of inoperable aortic stenosis. TAVR should be strongly considered for patients who are not surgical candidates for aortic valve replacement to improve their survival and functional status. Appropriate selection of patients will help to maximise the benefit of TAVR and reduce mortality from severe comorbidities.Abstract: FUNDING: Edwards Lifesciences.Copyright � 2015 Elsevier Ltd. All rights reserved.