The CoreValve US Pivotal Trial

Transcatheter aortic valve replacement (TAVR) has been developed as a less-invasive approach to address patients at high risk to extreme risk for surgical aortic valve replacement. The CoreValve US trial enrolled patients with symptomatic severe aortic stenosis into 2 separate cohorts: an extreme-risk cohort and a high-risk cohort. The study of transfemoral TAVR using the CoreValve system in extreme-risk patients achieved its primary end point of all-cause mortality or stroke at 1 year. This was achieved with a low stroke rate and low paravalvular leak rate that improved with time. The CoreValve high-risk trial is the only randomized trial of TAVR vs surgical aortic valve replacement to show superior survival of TAVR. This was achieved with a numerically lower rate of major stroke and statistically superior changes in aortic valve function from baseline to 1 year.