Navigation Links
Results of the COREVALVE EXTREME RISK trial presented at TCT 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
Cardiovascular Research Foundation

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:
(Date:11/27/2015)... ... November 27, 2015 , ... Keeping in mind ... mental health and wellness consultation, has collaborated with a leading web-based marketplace for ... gap experienced by parents and bring advice from parenting experts within their reach. ...
(Date:11/27/2015)... , ... November 27, 2015 , ... ... largest, most successful and prominent nonprofit healthcare organizations in the country. They have ... with various organizations, and helped advance the healthcare industry as a whole through ...
(Date:11/27/2015)... ... 27, 2015 , ... Avid collector, Andrew Hawley from Vintage Rock Posters, announces ... This is one of Joplin's most famous and beautiful concert posters. The concert was ... in Ann Arbor. The According to Hawley, "It is hard to believe that Joplin's ...
(Date:11/26/2015)... Marne, MI (PRWEB) , ... November 26, 2015 ... ... center for substance abuse located in central Michigan, have come together on Thanksgiving ... a specially produced video, available for viewing on the Serenity Point YouTube channel, ...
(Date:11/26/2015)... ... November 26, 2015 , ... CognisantMD and Cambridge Memorial ... in the Waterloo region. Using the Ocean Platform, family physicians can now order ... electronic medical record (EMR) without the need for redundant patient entry or an ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 26, 2015 ... of the  "2016 Future Horizons and ... Surface Marker Testing Market: Supplier Shares, ... their offering.  --> ... the  "2016 Future Horizons and Growth ...
(Date:11/25/2015)... WASHINGTON , Nov. 25, 2015  The ... Obstetricians and Gynecologists (ACOG), and the March of ... bipartisan Protecting Our Infants Act of 2015 ... the number of newborns born exposed to drugs, ... Since the bill,s introduction, all three organizations have ...
(Date:11/25/2015)... 25, 2015  ARKRAY USA , ... provide evidence demonstrating the accuracy of its blood glucose ... Insulin Resistance, Diabetes and Cardiovascular Disease in ... Company,s GLUCOCARD ® 01 meter and the Assure ... The ability to accurately measure glucose levels in blood ...
Breaking Medicine Technology: