Elsevier

The Lancet

Volume 385, Issue 9986, 20–26 June 2015, Pages 2485-2491
The Lancet

Articles
5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial

https://doi.org/10.1016/S0140-6736(15)60290-2Get rights and content

Summary

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.

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.

Findings

We screened 3015 patients, of whom 358 were enrolled (mean age 83 years, Society of Thoracic Surgeons Predicted Risk of Mortality 11·7%, 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 71·8% in the TAVR group versus 93·6% in the standard treatment group (hazard ratio 0·50, 95% CI 0·39–0·65; p<0·0001). 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 1·52 cm2 at 5 years, mean gradient 10·6 mm Hg at 5 years), with no evidence of structural valve deterioration.

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.

Funding

Edwards Lifesciences.

Introduction

Severe symptomatic aortic stenosis is a common valvular heart disease in elderly people and, if not treated with surgical aortic valve replacement, can be rapidly fatal. This seminal observation on the time course of aortic stenosis was made by Braunwald and Ross almost 50 years ago from a small number of patients with severe aortic stenosis who did not undergo surgery.1, 2 The Placement of Aortic Transcatheter Valves (PARTNER) trial compared clinical and echocardiographic data for high-risk patients treated either with a first-generation transcatheter aortic valve replacement (TAVR) or with standard treatment.3, 4, 5

1-year follow-up from the PARTNER trial showed mortality and functional benefits of TAVR compared with standard treatment, leading the US Food & Drug Administration to approve TAVR.4 Data at 2 years and 3 years showed similar results.3, 5 This report presents the prespecified final 5-year follow-up of patients deemed inoperable.

Section snippets

Study design and participants

We did this randomised controlled trial at 21 experienced valve centres in Canada, Germany, and the USA. We included patients with severe symptomatic aortic stenosis (aortic valve area <0·8 cm2) who were not candidates for surgical aortic valve replacement because of clinical or anatomical factors. The risk status of patients, including Society of Thoracic Surgeons Predicted Risk of Mortality (STS) was assessed by a team of experienced cardiac surgeons, interventional cardiologists, and others.

Results

We screened 3015 patients, of whom 358 patients were enrolled between May 11, 2007, and March 16, 2009. 179 patients were assigned to each treatment group. The appendix shows the trial profile and baseline characteristics.4, 6 Mean age was 83 years, mean STS was 11·7%, and 54% of participants were female. 140 (79%) of 179 patients in the standard treatment group underwent balloon aortic valvuloplasty during the trial.

At 5 years, risk of mortality was 71·8% in the TAVR group and 93·6% in the

Discussion

Our findings show a sustained benefit of TAVR as measured by all-cause mortality, cardiovascular mortality, repeat hospital admission, and functional status. Valves were durable, with no increase in transvalvular gradient, attrition of valve area, or worsening of aortic regurgitation. Other important findings were: (1) cardiovascular mortality and all-cause mortality benefits occurred even in patients with high STS; (2) patients with oxygen-dependent chronic obstructive pulmonary disease might

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  • Cited by (687)

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    J J Akin MS has no affiliations

    M J Davidson MD died in January, 2015

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