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.

MedStar author(s):
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
Name of journal: Lancet (London, England)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.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.All authors: Akin J, Anderson WN, Babaliaros V, Bavaria J, Blackstone EH, Brown DL, Davidson MJ, Douglas PS, Fontana GP, Hahn RT, Herrmann HC, Kapadia S, Kodali SK, Leon MB, Mack MJ, Makkar RR, Miller DC, Moses JW, PARTNER 1 trial investigators, Pichard A, Smith CR, Svensson LG, Thourani VH, Tuzcu EM, Webb JG, Williams MDigital Object Identifier: Date added to catalog: 2016-01-13
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Item type Current library Collection Call number Status Date due Barcode
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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