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Results of the COREVALVE EXTREME RISK trial presented at TCT 2013
Date:10/29/2013

SAN FRANCISCO, CA October 29, 2013 In a clinical trial, a self-expanding transcatheter aortic valve met the key performance objective of reducing death and stroke in patients with severe aortic stenosis at "extreme risk" for surgery.Results of the COREVALVE EXTREME RISK trial were presented today at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.

Degenerative aortic stenosis is a progressive disease with a poor prognosis in the absence of surgical aortic valve replacement. For patients at extreme risk for surgical complications, transcatheter aortic valve technologies offer a less invasive option of therapy for aortic stenosis.

The COREVALVE EXTREME RISK trial was a prospective, multicenter, controlled, non-randomized, single-arm investigation evaluating the safety and efficacy of the transfemorally implanted CoreValve self-expanding transcatheter heart valve. The trial was conducted in 487 patients with symptomatic, severe aortic stenosis.

All patients were deemed to be at extreme risk for surgical aortic valve replacement, and were thus treated with the Corevalve device. The primary endpoint was a composite of all-cause mortality or major stroke rate at 12 months; the Kaplan-Meier determined event rate was compared with a pre-specified objective performance goal (OPG).

Of the 487 patients enrolled in the study, 471 had an attempted implantation and were designated as the primary "as treated" analysis population. Patients were elderly (83.1 years), and were severely symptomatic (NYHA class III or IV, 91.9 percent). The Society for Thoracic Surgery Predicted Risk of Mortality was 10.3 percent 5.6 percent and was > 15 percent in 17.6 percent of patients.

At 12 months, the composite rate of death or major stroke wa
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Contact: Judy Romero
jromero@crf.org
Cardiovascular Research Foundation
Source:Eurekalert

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