Five-Year Clinical and Echocardiographic Outcomes From the NOTION Randomized Clinical Trial in Patients at Lower Surgical Risk

Abstract

Background: The NOTION trial (Nordic Aortic Valve Intervention) was designed to compare transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in patients ≥70 years old with isolated severe aortic valve stenosis. Clinical and echocardiographic outcomes are presented after 5 years. Methods: Patients were enrolled at 3 Nordic centers and randomized 1:1 to TAVR using the self-expanding CoreValve prosthesis (n=145) or SAVR using any stented bioprostheses (n=135). The primary composite outcome was the rate of all-cause mortality, stroke, or myocardial infarction at 1 year defined according to Valve Academic Research Consortium-2 criteria. Results: Baseline characteristics were similar. The mean age was 79.1±4.8 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 3.0%±1.7%. After 5 years, there were no differences between TAVR and SAVR in the composite outcome (Kaplan-Meier estimates 38.0% versus 36.3%, log-rank test P =0.86) or any of its components. TAVR patients had larger prosthetic valve area (1.7 cm 2 versus 1.2 cm 2 , P <0.001) with a lower mean transprosthetic gradient (8.2 mm Hg versus 13.7 mm Hg, P <0.001), both unchanged over time. More TAVR patients had moderate/severe total aortic regurgitation (8.2% versus 0.0%, P <0.001) and a new pacemaker (43.7% versus 8.7%, P <0.001). Four patients had prosthetic reintervention and no difference was found for functional outcomes. Conclusions: These are currently the longest follow-up data comparing TAVR and SAVR in lower risk patients, demonstrating no statistical difference for major clinical outcomes 5 years after TAVR with a self-expanding prosthesis compared to SAVR. Higher rates of prosthetic regurgitation and pacemaker implantation were seen after TAVR. Clinical Trial Registration: URL: https://clinicaltrials.gov . Unique identifier: NCT01057173.

TAVI and the future of aortic valve replacement

“…In the most recently published clinical and echocardiographic results, the trial concluded after 5 years that no significant differences were observed between the two patient groups in terms of the composite rate of all‐cause death, stroke, or MI . Also after 5 years of follow up the surgical group were found to have experienced more new‐onset or worsening atrial fibrillation, however the TAVI treated patients were found to require more pacemaker implantations on average as well as higher rates of paravalvular leakage (PVL) . NOTION as a trial can be considered to have some limitations however due to its small population size and the fact that this population may not be fully reflective of low‐risk patients with aortic stenosis.…”

Transcatheter Aortic Valve Implantation Current Indications and Future Directions

“…TAVR using the Edwards Sapien XT prosthesis was found to be non-inferior to conventional surgery for the primary endpoint death and disabling stroke in intermediate risk patients; however, trialists found a higher rate of significant (≥moderate) paravalvular leakage with TAVR vs. SAVR. NOTION (Nordic Aortic Valve Intervention) was an all-comers trial investigating TAVR vs. SAVR and found lower rates of kidney injury, bleeding, and new-onset atrial fibrillation among patients undergoing TAVR (14). Similarly, also the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial using the self-expanding CoreValve or Evolut R prosthesis proved safety and efficacy of TAVR in intermediate surgical risk patients (15).…”

Lo mejor del Congreso 2019 del American College of Cardiology

“…De estos, 82% presentaba riesgo quirúrgico bajo (evaluado mediante un score predictor de mortalidad de la Sociedad de Cirujanos Torácicos [STS-PROM] menor a 4%). En el seguimiento a cinco años no hubo diferencias significativas en el objetivo final primario de muerte por cualquier causa, accidente cerebrovascular (ACV) e infarto (39,2% para TAVI vs 35,8% para cirugía, p=0,78) (6) .…”