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Safety and efficacy of a self-expanding vs a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: A randomized non-inferiority trial

The Lancet Nov 11, 2019

Lanz J, Kim WK, Walther T, et al. - Individuals (aged ≥ 75 years; n = 5,132) who underwent transfemoral transcatheter aortic valve replacement (TAVR) for treatment of symptomatic severe aortic stenosis, and who were considered to be at heightened surgical risk, were enrolled in this randomized non-inferiority trial, at 20 tertiary heart valve centres in Germany, the Netherlands, Switzerland, and the UK in order to contrast the self-expanding ACURATE neo TAVR system with the balloon-expandable SAPIEN 3 TAVR system relative to early safety and efficiency. Of 5,132 people, 739 were recruited. In terms of early safety and clinical effectiveness outcomes, in comparison with the balloon-expandable SAPIEN 3 device, TAVR with the self-expanding ACURATE neo could not reach non-inferiority. However, in distinguishing the performance of various TAVR systems, an early composite safety and efficacy endpoint was beneficial.
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