Background:
The NOTION trial (Nordic Aortic Valve Intervention) was designed to compare transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in patients ≥70 years old with isolated severe aortic valve stenosis. Clinical and echocardiographic outcomes are presented after 5 years.
Methods:
Patients were enrolled at 3 Nordic centers and randomized 1:1 to TAVR using the self-expanding CoreValve prosthesis (n=145) or SAVR using any stented bioprostheses (n=135). The primary composite outcome was the rate of all-cause mortality, stroke, or myocardial infarction at 1 year defined according to Valve Academic Research Consortium-2 criteria.
Results:
Baseline characteristics were similar. The mean age was 79.1±4.8 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 3.0%±1.7%. After 5 years, there were no differences between TAVR and SAVR in the composite outcome (Kaplan-Meier estimates 38.0% versus 36.3%, log-rank test
P
=0.86) or any of its components. TAVR patients had larger prosthetic valve area (1.7 cm
2
versus 1.2 cm
2
,
P
<0.001) with a lower mean transprosthetic gradient (8.2 mm Hg versus 13.7 mm Hg,
P
<0.001), both unchanged over time. More TAVR patients had moderate/severe total aortic regurgitation (8.2% versus 0.0%,
P
<0.001) and a new pacemaker (43.7% versus 8.7%,
P
<0.001). Four patients had prosthetic reintervention and no difference was found for functional outcomes.
Conclusions:
These are currently the longest follow-up data comparing TAVR and SAVR in lower risk patients, demonstrating no statistical difference for major clinical outcomes 5 years after TAVR with a self-expanding prosthesis compared to SAVR. Higher rates of prosthetic regurgitation and pacemaker implantation were seen after TAVR.
Clinical Trial Registration:
URL:
https://clinicaltrials.gov
. Unique identifier: NCT01057173.
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