• Semin. Thorac. Cardiovasc. Surg. · Jan 2014

    The CoreValve US pivotal trial.

    • Colin M Barker and Michael J Reardon.
    • Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
    • Semin. Thorac. Cardiovasc. Surg. 2014 Jan 1; 26 (3): 179-86.

    AbstractTranscatheter 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.Copyright © 2014 Elsevier Inc. All rights reserved.

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