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Valve Disease2015Journal of the American Medical Association

NOTION

Nordic Aortic Valve Intervention

Sample Size
280
Study Design
Multicenter, randomized, controlled, noninferiority trial
Year Published
2015
Category
Valve Disease

Clinical Question

Is TAVR noninferior to SAVR in an all-comers population of patients with severe aortic stenosis, including those at lower surgical risk?

Population

All-comers aged 70 years or older with severe aortic stenosis at three Nordic centers in Denmark, Sweden, and Finland. No STS score threshold was applied for inclusion.

Intervention

TAVR with the Medtronic CoreValve self-expanding prosthesis

Control

Surgical aortic valve replacement (SAVR)

Primary Endpoint

Composite of all-cause mortality, stroke, or myocardial infarction at 1 year

Key Findings

1

The primary composite endpoint occurred in 13.1% of TAVR vs 16.3% of SAVR patients at 1 year (p=0.43 for superiority).

2

At 5 years, the primary composite endpoint remained similar: 39.2% TAVR vs 35.8% SAVR (p=0.78).

3

Pacemaker implantation was significantly higher with TAVR (34.1% vs 1.6%).

4

Conduction abnormalities, including new left bundle branch block, were more common with the self-expanding valve.

5

The mean STS score was 2.9%, making this the first trial to demonstrate TAVR safety in a predominantly lower-risk cohort.

Impact on Clinical Practice

NOTION was a pioneering trial that challenged the prevailing notion that TAVR should be limited to high-risk or inoperable patients. As the first randomized comparison in an all-comers population with a mean STS score under 3%, it provided early proof of concept that TAVR could be safe and effective in lower-risk patients. While the trial was relatively small and underpowered for definitive conclusions, its findings were consistent with what the larger PARTNER 3 and Evolut Low Risk trials later confirmed. NOTION demonstrated that contemporary TAVR technology could achieve outcomes comparable to surgery even in patients with excellent surgical risk profiles. The major concern raised by NOTION was the very high pacemaker implantation rate (34.1%) with the CoreValve, which was significantly higher than in later trials using refined implantation techniques and newer-generation devices. This finding drove device and technique modifications that substantially reduced pacemaker rates in subsequent practice.

Guideline Impact

NOTION provided early-level evidence supporting the expansion of TAVR to lower-risk patients and was cited as hypothesis-generating evidence in the 2017 ESC/EACTS guidelines. Its findings were later corroborated by the larger PARTNER 3 and Evolut Low Risk trials.

Limitations

Small sample size (280 patients) limits statistical power and the ability to draw definitive conclusions.

The very high pacemaker rate (34.1%) with the CoreValve may reflect early-generation device and technique limitations.

Single-valve platform study (CoreValve) limits generalizability to other TAVR systems.

Sandeep M. Patel, MD
Reviewed by Sandeep M. Patel, MD
Structural & Interventional Cardiologist

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PARTNER 3
2019 · New England Journal of Medicine
Evolut Low Risk
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SURTAVI
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