Five-year clinical and echocardiographic outcomes from the NOTION randomized clinical trial in patients at lower surgical risk
Circulation Jun 15, 2019
Thyregod HGH, et al. - Researchers describe the 5-year clinical and echocardiographic outcomes from the NOTION trial (Nordic Aortic Valve Intervention) that involved patients ≥70 years old with isolated severe aortic valve stenosis in whom transcatheter aortic valve replacement (TAVR) was compared to surgical aortic valve replacement (SAVR). Using randomization 1:1, patients enrolled at 3 Nordic centers were allocated to TAVR using the self-expanding CoreValve prosthesis (n=145) or SAVR using any stented bioprostheses (n=135). Using Valve Academic Research Consortium-2 criteria, the rate of all-cause death, stroke, or myocardial infarction at 1 year was considered as the primary composite outcome. With regard to major clinical outcomes 5 years after the procedure, no statistical difference was evident between TAVR with a self-expanding prosthesis vs SAVR, as shown by these longest follow-up data comparing TAVR and SAVR in lower risk patients. Post-TAVR, the rates of prosthetic regurgitation and pacemaker implantation were higher.
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