Articles5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial
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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