The CoreValve US pivotal trial

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

Abstract

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.

Keywords: CoreValve; TAVR; extreme risk; high risk; pivotal study.

MeSH terms

  • Aortic Valve Stenosis / diagnosis
  • Aortic Valve Stenosis / mortality
  • Aortic Valve Stenosis / physiopathology
  • Aortic Valve Stenosis / surgery
  • Aortic Valve Stenosis / therapy*
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation*
  • Cardiac Catheterization / methods
  • Cardiac Catheterization / mortality
  • Evidence-Based Medicine
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation*
  • Heart Valve Prosthesis Implantation / methods
  • Heart Valve Prosthesis Implantation / mortality
  • Heart Valve Prosthesis*
  • Humans
  • Prosthesis Design
  • Randomized Controlled Trials as Topic
  • Risk Assessment
  • Risk Factors
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome