February 1, 2019Circulation
Five-Year Clinical and Echocardiographic Outcomes From the NOTION Randomized Clinical Trial in Patients at Lower Surgical Risk
Why the study?
The NOTION trial was designed to compare transcatheter aortic valve replacement with surgical aortic valve replacement in patients aged 70 years or older with isolated severe aortic valve stenosis.
Does TAVR compared to SAVR improve clinical and echocardiographic outcomes in patients ≥70 years old with isolated severe aortic valve stenosis at lower surgical risk?
Comparison
TAVR with self-expanding CoreValve prosthesis vs SAVR with stented bioprosthesis
Design
Multicenter 1:1 randomized trial
Follow-up
5 years
Authors
Discussion
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Member takes
Implication
Supports TAVR-SAVR equivalence on major 5-year outcomes in lower-risk older patients; extends randomized evidence to longer-term follow-up.
Structured PICO
Does TAVR compared to SAVR improve clinical and echocardiographic outcomes in patients ≥70 years old with isolated severe aortic valve stenosis at lower surgical risk?
P
Population
280 patients ≥70 years old with isolated severe aortic valve stenosis at lower surgical risk, mean age 79.1 years, enrolled at 3 Nordic centers.
I
Intervention
Transcatheter aortic valve replacement (TAVR) using the self-expanding CoreValve prosthesis
C
Comparator
Surgical aortic valve replacement (SAVR) using any stented bioprostheses
O
Outcome
Composite of all-cause mortality, stroke, or myocardial infarction defined according to Valve Academic Research Consortium-2 criteria (assessed at 5 years)composite
TAVR with a self-expanding prosthesis demonstrates similar 5-year major clinical outcomes compared to SAVR in lower-risk older patients with severe aortic stenosis, though with higher rates of pacemaker implantation and paravalvular regurgitation.
Cite This Study
Thyregod et al. (2019) studied this question.