Articles5-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
Introduction
Transcatheter aortic valve replacement (TAVR) is an alternative to surgical valve replacement in high-risk patients with aortic stenosis.1, 2 The Placement of Aortic Transcatheter Valves (PARTNER) study is a randomised trial comparing TAVR with standard-of-care treatments in both inoperable and high surgical risk patients with aortic stenosis. 1-year mortality after TAVR was superior to standard non-operative treatment in patients who could not have surgery and was non-inferior to surgical aortic valve replacement (SAVR) in high-risk patients who could have surgery.3, 4 These findings were maintained at 2 years and 3 years.5, 6, 7 This report describes the final 5-year clinical and valve performance outcomes for high-risk patients in the PARTNER-1 trial.
Section snippets
Study design and participants
Details of the trial have been previously published.4 We did this randomised controlled trial at 25 hospitals: two in Canada, one in Germany, and 22 in the USA. Inclusion criteria were severe symptomatic aortic stenosis (aortic valve area ≤0·8 cm2, and resting or inducible peak velocity ≥4 m/s or a mean valve gradient ≥40 mm Hg) and high-risk status for SAVR, as assessed by a heart team, which included experienced surgeons. Patients were considered to be at high surgical risk if they had
Results
We screened 3105 patients, of whom 699 were enrolled: 348 assigned to TAVR and 351 assigned to SAVR (figure 1). The appendix shows baseline characteristics. Four patients in the TAVR group did not receive it, five patients were lost to follow-up and four withdrew after receiving the procedure. In the SAVR group, 38 patients did not receive the allocated procedure, mainly because of patient decision not to undergo surgery; 19 of these withdrew immediately. 12 patients assigned to SAVR were lost
Discussion
The final 5-year follow-up of high risk surgical patients shows equivalent outcomes after TAVR and SAVR. We detected no significant differences in all-cause mortality, cardiovascular mortality, stroke, or need for repeat hospital admission. Functional outcomes were also similar and preservation of valve haemodynamics was equivalent in both groups. Although we recorded no evidence of structural valve deterioration in either group, moderate or severe aortic regurgitation caused by paravalvular
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M J Davidson died in January, 2015