Objective
to compare long-term (7year) clinical outcomes and bioprosthetic valve durability between transfemoral TAVI with SAPIEN 3 and surgical AVR in patients at low surgical risk with severe symptomatic aortic stenosis
Study
prospective, multicentre, open-label, randomised trial
Population
patients at low surgical risk with severe symptomatic aortic stenosis who were suitable candidates for either transfemoral TAVI or surgical aortic valve replacement
Endpoints
1) a non-hierarchical composite of death, stroke, or rehospitalisation related to the procedure, valve, or heart failure; 2) a hierarchical composite of death, disabling stroke, non-disabling stroke, and rehospitalisation days
Conclusion
At seven years, no significant differences in terms of two primary composite endpoints involving death, stroke, and rehospitalisation were observed between low-risk patients with severe symptomatic aortic stenosis who had undergone TAVI and those who had undergone surgery.
Leon et al. N Engl J Med. 2025 Oct 27.