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 Oct 06, 2019
Lanz J, Kim WK, Walther T, et al. - Through this randomized non-inferiority trial of 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, enrolled at 20 tertiary heart valve centres in Germany, the Netherlands, Switzerland, and the UK, experts contrasted the self-expanding ACURATE neo TAVR system with the balloon-expandable SAPIEN 3 TAVR system relative to early safety and efficiency. In terms of early safety and clinical efficiency outcomes, TAVR with the self-expanding ACURATE neo did not reach non-inferiority in comparison with the balloon-expandable SAPIEN 3 device. Moreover, in distinguishing the performance of various TAVR systems, an early composite safety and efficiency endpoint was beneficial.
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