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Semin Thorac Cardiovasc Surg. 2014 Autumn;26(3):179-86. doi: 10.1053/j.semtcvs.2014.10.001. Epub 2014 Oct 24.

The CoreValve US pivotal trial.

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Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas. Electronic address:


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.


CoreValve; TAVR; extreme risk; high risk; pivotal study

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