Feature | November 01, 2013

Clinical Trial Finds CoreValve Reduces Rate of Death, Stroke in Patients With Aortic Stenosis

Results of the CoreValve Extreme Risk trial presented at TCT 2013

heart valve repair hybrid or cath lab structural heart tct medtronic corevalve
November 1, 2013 — In a clinical trial, the Medtronic Corevalve 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 at the 25th annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2013) in San Francisco.
 
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 (PV) leak at one month who survived to one year experienced a reduction in PV leak 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 Jeffrey Popma, M.D., lead investigator, director, Interventional Cardiology, Beth Israel Deaconess Medical Center.
 
Medtronic has three FDA IDE trials evaluating the Corevalve for high-risk and extreme-risk surgical patients and in patients at intermediate risk for open-heart aortic valve replacement (SURTAVI Trial).
 
For more information: www.crf.org, www.medtronic.com

Related Content

AtriCure, AtriClip PRO2 LAA Exclusion System, left atrial appendage, FDA clearance
Technology | Left Atrial Appendage (LAA) Occluders| April 29, 2016
April 29, 2016 — AtriCure Inc. announced U.S.
Feature | Business| April 28, 2016 | Dave Fornell
 
Technology | Stents Peripheral| April 27, 2016
Veniti Inc. announced the first successful treatment with the Vici Verto Venous Stent System of a patient suffering...
Mitralign Percutaneous Annuloplasty System, MPAS, CE Mark approval
News | Annuloplasty Rings| April 27, 2016
Mitralign Inc. announced its Mitralign Percutaneous Annuloplasty System (MPAS) has received CE mark approval from its...
Auris Surgical Robotics, acquisition, Hansen Medical
News | Robotic Systems| April 26, 2016
Auris Surgical Robotics Inc. and Hansen Medical Inc. announced that they have signed a definitive merger agreement...
Siemens Sensis Vibe, hemodyanamics system

Siemens released the Sensis Vibe hemodyanamics system at ACC.16. The newer system offers better integration of cath lab data into cath lab reports and the electronic medical record (EMR).

Feature | ACC| April 25, 2016 | Jon Brubaker, MBA, RCVT, Tom Watson, BS, RCVT, and Sabrina Newell MS, RCS
There were several trends seen in new cardiovascular technologies showcased on the expo floor at the 2016 American...
Medtronic, Drug-Filled Stent, RevElution Trial results, ACC.16, CE Mark
News | Stents Drug Eluting| April 21, 2016
Medtronic plc announced new clinical data from one of the endpoints in the RevElution Trial for its novel, next-...
Boston Scientific, Fetch 2 aspiration catheter, Class 1 recall
News | Thrombectomy Devices| April 20, 2016
April 20, 2016 — Boston Scientific Corp. announced a U.S.
TAVR, Sapien 3, ACC.16
Feature | Heart Valve Repair| April 19, 2016 | Michael J. Rinaldi, M.D., FACC, FSCAI
The continuation of positive clinical trial data for transcatheter aortic valve repair (TAVR), showing it is equal to
ischemic postconditioning, STEMI patients, clinical outcomes, ACC.16
News | Cath Lab| April 19, 2016
A large randomized controlled trial of ischemic postconditioning in patients who had experienced ST-segment elevation...
Overlay Init