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).
RCT (n=280)
1:1
Yes
Absolute Event Rate: 13.1% vs 16.3%
p-value: p=0.43 for superiority
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).
“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.”
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).