NOTION-2
Nordic Aortic Valve Intervention 2
Paziente / Popolazione Intervento / Esposizione Confronto Esito
In 370 younger, low-risk patients (≤75 years) with severe aortic stenosis, transcatheter aortic-valve implantation was not shown non-inferior for 1-year death, stroke, or rehospitalisation compared with surgical aortic-valve replacement.
N
370
Disegno
Multicentre RCT, non-inferiority
Esito
All-cause mortality, stroke, or rehospitalisation at 12 months
Rilevanza
3
RisultatoTAVI 10.2% vs SAVR 7.1% (HR 1.4, 95% CI 0.7-2.9; risk difference 3.1%, 95% CI -2.7 to 8.8, P=0.3); non-inferiority not met, with worse signals for TAVI in bicuspid anatomy.
Jørgensen TH, et al. Eur Heart J. 2024;45(37):3804-14. 10.1093/eurheartj/ehae331
Discussione e critica
Underpowered with low event rates, so non-inferiority could not be declared, and the bicuspid subgroup did worse with TAVI. Cautions against uncritically extending TAVR to younger (≤75) low-risk patients.