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:2/12/2016)... ... February 12, 2016 , ... The ... Zuckerberg San Francisco General Hospital on April 5-7. The series is a multi-day, ... new habits. The workshops cover a broad range of topics, including coaching skills, ...
(Date:2/12/2016)... ... February 12, 2016 , ... Fisher House Foundation Chairman and CEO ... Lee, Nevada Military Support Alliance president Scott Bensing, and Peggy Kearns Director, VA Southern ... Nevada Healthcare System. This will be the first Fisher House in Nevada, and ...
(Date:2/12/2016)... ... February 12, 2016 , ... Vail knee specialist ... Leaders to Know in 2016 . The list consists of physicians establishing, leading and ... establish this list. , An Ambulatory Surgery Center, also known as an ASC, ...
(Date:2/12/2016)... , ... February 12, 2016 , ... Donor Network West, ... California and Nevada, announced a partnership with San Ramon Regional Medical Center. Under the ... hospital’s facilities as a way to accommodate a more certain time frame for donor ...
(Date:2/12/2016)... ... February 12, 2016 , ... ... surrounding communities by continuing it’s commitment to act as Agents of Change in ... works closely with area homeless families to fulfill immediate needs and help them ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... PRO-DEX, INC. (NasdaqCM: PDEX) today announced financial results ... The Company also filed its Quarterly Report on Form 10-Q ... Securities and Exchange Commission today. --> ... --> --> Net sales for the ... 95%, to $5.4 million from $2.8 million for the three ...
(Date:2/11/2016)... , Feb. 11, 2016   Health 2.0 , ... new health technologies, announced today " 10 Year Global ... health tech over the past ten years.   ... a decade, Health 2.0 has served as the preeminent ... connected with thousands of technologies, companies, innovators, and patient-activists ...
(Date:2/11/2016)... 11, 2016  AfterPill.com is reporting that this week,s ... for all women who are at risk of unintended ... year and raises the risks of unprotected sex in ... According to the Guttmacher Institute, there are 43 ... child-bearing age, who have sex without the intention of ...
Breaking Medicine Technology: