Why is this study important?

• There is limited literature on the intermediate to long-term safety and efficacy of transcatheter aortic valve replacement (TAVR) compared to traditional aortic valve replacement (SAVR) in low-surgical-risk patients with severe aortic stenosis. 
• The Evolut Low-Risk Trial using the supra-annular self-expanding valve is currently the largest randomized trial comparing TAVR to SAVR in younger, low-risk patients with severe aortic stenosis. 

What question was this study supposed to answer?

• The current study sought to examine the five-year clinical and hemodynamic outcomes with TAVR as compared to SAVR in patients from the Evolut Low-Risk trial (1:1 randomization). 
• Aortic valve replacement was attempted in a total of 1,414 patients (Evolut TAVR; n=730 and SAVR; n=684). At the five-year mark, a total of 1,269 patients (Evolut TAVR; n=671 and SAVR; n=598) were available for analysis. 
• The primary endpoint of the trial was a composite of all-cause mortality or disabling stroke post-procedure. 
• Other endpoints were valve performance using Doppler echocardiographic measurements, paravalvular regurgitation (PVR) at 30 days and five years, quality of life as assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ), and New York Heart Association (NYHA) class. 

What did the study show?

• Low surgical risk patients with severe aortic stenosis treated with Evolut TAVR showed comparable rates of all-cause mortality or disabling stroke at 5 years as compared to SAVR (15.5% TAVR and 16.4% SAVR, P=0.47). 
• The mean aortic valve gradient and effective orifice area (EOA) favored Evolut TAVR over SAVR. 
• Cardiovascular mortality rates between the two groups were not significantly different. 
• There was no difference in valve intervention rates, moderate or greater PVR, or alive and well status between the two groups. 
• In summary, the Evolut Low-Risk Trial at 5 years demonstrates that the use of Evolut TAVR is a safe, effective, and durable alternative to SAVR in low-risk surgical patients with severe aortic stenosis.