Objective
to compare the clinical outcomes of newer generation self expandable Evolut R (SEV) and balloon expandable valve Sapien 3 (BEV) in high-risk patients with symptomatic aortic stenosis undergoing TAVI
Study
open-label, multicentre randomised trial (powered for equivalence with margin of 10%)
Population
patients â¥75 years at high-risk (EuroScore â¥20% and/or STS risk score â¥10%)
Endpoints
composite all-cause death, stroke, moderate/severe prosthetic valve regurgitation and permanent pacemaker implantation at 30 days
Conclusion
newer generation self-expandable valves and balloon-expandable valves are equivalent with respect to adverse events for transfemoral treatment of symptomatic aortic stenosis
Thiele et al. European Heart Journal. 2020;41:1890-99
