Public Release: 

Two-year results of the CoreValve US Pivotal trial reported at TCT 2014

Clinical trial examines the long term outcomes of a self-expanding transcatheter aortic valve in inoperable patients with aortic stenosis

Cardiovascular Research Foundation

WASHINGTON, DC - September 13, 2014 - In extended follow-up from a clinical trial, a self-expanding transcatheter aortic valve was shown to have low rates of all-cause mortality and major stroke. Findings were reported today at the 26th 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. Previous trials have shown that a self-expanding transcatheter aortic valve was associated with low rates of all-cause mortality and major stroke at one year, but the long term effects of this device are unknown.

The CoreValve US Pivotal was a prospective, non-randomized single-arm, multicenter trial to determine the safety and efficacy of self-expanding TAVR at two-years in patients at extreme risk for surgery. The primary endpoint was a composite of all-cause mortality or major stroke rate at 12 months. Efficacy and safety outcomes at two years were also examined.

The study enrolled a total of 489 patients undergoing transfemoral self-expanding TAVR deemed to be at extreme risk for surgery. The one-year rate of all-cause mortality or major stroke was 26.0 percent (all-cause mortality, 24.3 percent; major stroke 4.3 percent). After two years, the rate of all-cause mortality or major stroke was 38.0 percent. Both one and two year rates of adverse outcomes compared favorably with historical performance criteria established among medically managed patients with aortic stenosis. Patients treated with the self-expanding TAVR device also reported improvement in NYHA classifications, durable improvement in hemodynamic valve performance, and low rates of moderate or severe aortic insufficiency.

"The first year results from the CoreValve US Pivotal Trial support the safety and efficacy of this therapy in patients unsuitable for surgical aortic valve replacement," said lead investigator Steven Yakubov, MD. Dr. Yakubov is Medical Director, OhioHealth Research Foundation at OhioHealth.

"The two-year results confirm the improved survival benefit in these patients."

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The CoreValve US Pivotal trial was funded by Medtronic. Dr. Yakubov reported no disclosures.

The results of the CoreValve US Pivotal trial will be presented on Saturday, September 13 at 12:00 PM EDT in the Main Arena (Level 3, Ballroom) of the Walter E. Washington Convention Center.

About CRF and TCT

The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with heart disease through high quality research and education. Since its inception in 1991, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies and therapies in interventional cardiovascular medicine.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. For more than 25 years, TCT has featured major medical research breakthroughs and gathered leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.

For more information, visit http://www.crf.org and http://www.tctconference.com.

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