title: The CoreValve US pivotal trial.
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.
authors.affiliation: Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.
authors.forename: Colin M
authors.initials: CM
authors.lastname: Barker
authors.affiliation: Department of Cardiothoracic Surgery, Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas. Electronic address: mreardon@tmhs.org.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Reardon
mesh_terms: D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D019317:Evidence-Based Medicine; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D006801:Humans; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
keywords: CoreValve; TAVR; extreme risk; high risk; pivotal study