Navigation Links
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 was 25.5 percent, significantly below the 95 percent confidence interval of the performance goal, which was set at 43 percent. While moderate paravalvular leak was observed in 11 percent of patients at one month, 80 percent of patients with moderate paravalvular leak (PVL) at one month who survived to one year experienced a reduction in PVL over time.

"The COREVALVE EXTREME RISK study achieved its primary endpoint of a reduction in all cause mortality or major stroke at one year compared to a rigorously defined OPG," said lead investigator Jeffrey J. Popma, MD. Dr. Popma is Director, Interventional Cardiology at Beth Israel Deaconess Medical Center.


'/>"/>

Contact: Judy Romero
jromero@crf.org
Cardiovascular Research Foundation
Source:Eurekalert

Related medicine news :

1. False-Positive Mammogram Results May Turn Out Not to Be: Study
2. Good intentions bring mixed results for Haitis disabled people
3. Presentation of 1-year IVAN and 2-year CATT study results
4. Groundbreaking Nigeria summit results in major commitment to reduce child deaths
5. Surprising results for use of dialysis for kidney failure in developing world
6. Stem Cell Study Shows Promising Results Against Heart Failure
7. Automated insulin dosage titration system demonstrates positive clinical study results
8. Quality of care, other issues may cause worse results in black prostate cancer surgery patients
9. Tight Blood-Sugar Control Shows Mixed Results for Health of Kidneys: Study
10. ACP-New York State Chapter partnership results in patient safety organization recognition
11. Long-term testosterone treatment for men results in reduced weight and waist size
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/26/2017)... ... July 26, 2017 , ... IDC-Eating Disorder Care is excited ... program located in Royal Oak, Michigan. IDC, formerly known as Inner Door ... providing the highest standards in the field of eating disorder treatment in the state ...
(Date:7/26/2017)... ... 2017 , ... The number of adults 65 years or older is expected ... asthma control in the population are not well described. In a study published in ... journal of the American Academy of Allergy, Asthma & Immunology (AAAAI), researchers identified factors ...
(Date:7/25/2017)... (PRWEB) , ... July 25, 2017 , ... ... protection assistance and finance management services to communities across North Carolina, is launching ... Advocacy Network to raise community support for the ongoing fight against bladder cancer. ...
(Date:7/25/2017)... ... ... Facing medical needs with a newborn boy this spring, Crowley Maritime ... for employees that is uncommon in American business: 12 weeks of fully paid parental ... employees as new parents. It keeps our family life more stable. I can be ...
(Date:7/24/2017)... ... July 24, 2017 , ... Cheerag D. Upadhyaya , M.D., ... Bloch Neuroscience Institute (SLMBNI), part of Saint Luke’s Health System . Dr. ... Cheerag D. Upadhyaya, MD. M.Sc., FAANS joins Stanley P. Fisher, M.D., who ...
Breaking Medicine News(10 mins):
(Date:7/12/2017)... and Company (NYSE: LLY ) has entered into ... litigation in the U.S. District Court for the Eastern District ... (tadalafil) unit dose patent. This patent was previously set ... agreement, Cialis exclusivity is now expected to end at the ... patent for Cialis is valid and infringed by companies seeking ...
(Date:7/11/2017)... N.J. , July 11, 2017  Bayer has awarded ... eight countries as part of its prestigious Bayer Hemophilia Awards ... Hospital of Philadelphia and Uniformed Services ... are among the winners. Grant recipients were announced last ... and Hemostasis (ISTH) 2017 Congress, Berlin, Germany ...
(Date:7/11/2017)... , July 11, 2017  Sysmex America, ... urinalysis diagnostic testing equipment as well as middleware ... a way to make quality assurance easier and ... "Sysmex is well known for the innovation that ... Quality Monitor elevates quality assurance processes to a ...
Breaking Medicine Technology: