Key result
Transcatheter aortic valve replacement was not significantly different from surgical replacement for the 1-year composite of death, stroke, or MI (13.1% vs. 16.3%; p=0.43 for superiority).
Why the study?
While TAVR is an option in select high-risk patients with severe aortic valve stenosis, it was unknown whether it could be safely introduced to lower-risk patients.
RCT (n=280)
1:1
Yes
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“The Nordic Aortic Valve Intervention (NOTION) trial was the first to randomise all-comer lower-risk patients (n=276) to TAVI with the CoreValve or SAVR. The mean age was 79 years, mean STS score 3.0±1.7%, and 82% of patients had an STS score <4%. No differences were observed between TAVI and SAVR in the composite endpoint of all-cause mortality, stroke, myocardial infarction, or separately, at one year, two years, and five years.”
“In 2020, TAVR seems like a tsunami that's totally overwhelming SAVR. And the question is, after the wave hits shore, is there going to be anything left in the surgical arena?”
Randomized trial compares outcomes of transcatheter and surgical aortic valve replacement in severe aortic valve stenosis, suggesting differing effectiveness.
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an option in certain high-risk surgical patients with severe aortic valve stenosis. It is unknown whether TAVR can be safely introduced to lower-risk patients. OBJECTIVES: The NOTION (Nordic Aortic Valve Intervention Trial) randomized clinical trial compared TAVR with surgical aortic valve replacement (SAVR) in an all-comers patient cohort. METHODS: Patients ≥ 70 years old with severe aortic valve stenosis and no significant coronary artery disease were randomized 1:1 to TAVR using a self-expanding bioprosthesis versus SAVR. The primary outcome was the composite rate of death from any cause, stroke, or myocardial infarction (MI) at 1 year. RESULTS: A total of 280 patients were randomized at 3 Nordic centers. Mean age was 79.1 years, and 81.8% were considered low-risk patients. In the intention-to-treat population, no significant difference in the primary endpoint was found (13.1% vs. 16.3%; p = 0.43 for superiority). The result did not change in the as-treated population. No difference in the rate of cardiovascular death or prosthesis reintervention was found. Compared with SAVR-treated patients, TAVR-treated patients had more conduction abnormalities requiring pacemaker implantation, larger improvement in effective orifice area, more total aortic valve regurgitation, and higher New York Heart Association functional class at 1 year. SAVR-treated patients had more major or life-threatening bleeding, cardiogenic shock, acute kidney injury (stage II or III), and new-onset or worsening atrial fibrillation at 30 days than did TAVR-treated patients. CONCLUSIONS: In the NOTION trial, no significant difference between TAVR and SAVR was found for the composite rate of death from any cause, stroke, or MI after 1 year. (Nordic Aortic Valve Intervention Trial [NOTION]; NCT01057173).
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Thyregod et al. (2015) conducted an RCT in severe aortic valve stenosis (n=280). Transcatheter aortic valve replacement (TAVR) vs. Surgical aortic valve replacement (SAVR) was evaluated on composite rate of death from any cause, stroke, or myocardial infarction (MI) at 1 year (p=0.43 for superiority). Transcatheter aortic valve replacement was not significantly different from surgical replacement for the 1-year composite of death, stroke, or MI (13.1% vs. 16.3%; p=0.43 for superiority).
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