SAN FRANCISCO, Sept. 29, 2019 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced new data demonstrating early and sustained health status advantages for severe aortic stenosis (AS) patients at low surgical risk treated with the Edwards SAPIEN 3 valve. Study results were presented as a late-breaking clinical trial at the 31st Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, and simultaneously published online to the Journal of the American College of Cardiology.
The new 1-year data, involving approximately 1,000 patients enrolled in the PARTNER 3 Trial, showed significant improvements in health status as well as overall physical and mental well-being after treatment with either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 valve or surgical aortic valve replacement.
When the treatment strategies were compared, TAVR patients improved more rapidly than surgery patients as demonstrated by a difference of 16.0 points between the groups in Kansas City Cardiomyopathy Questionnaire Overall Summary Scores (KCCQ-OS) at 1 month (p < 0.001). While similar findings of early health status benefit with TAVR have been seen in prior studies of higher risk AS patients, this study also observed a sustained health status benefit of TAVR compared with SAVR at later time points of 6 months (2.6 points (p = 0.002)) and 1 year (1.8 points (p = 0.03)). Furthermore, when mortality and the extent of quality of life improvement were evaluated together, the benefit of transfemoral TAVR with the SAPIEN 3 valve compared with surgery persisted through 1 year.
"Taken together with the clinical outcomes of the PARTNER 3 Trial, these health status findings further support the use of TAVR in patients with severe aortic stenosis at low surgical risk," said Suzanne J. Baron, M.D., M.Sc., director of interventional cardiology research at Lahey Hospital and Medical Center.
The U.S. Food and Drug Administration approved the Edwards SAPIEN 3 and SAPIEN 3 Ultra valves for low-risk patients last month, based on data from the landmark PARTNER 3 Trial, and the launch is underway. In the PARTNER 3 Trial, TAVR with the SAPIEN 3 system achieved superiority, with a 46 percent reduction in the event rate for the primary endpoint of the trial, which was a composite of all-cause mortality, all stroke and rehospitalization at one year.
"SAPIEN 3 TAVR is a proven technology with demonstrated clinical and health status superiority for these low-risk patients," said Larry Wood, Edwards' corporate vice president of transcatheter aortic valve replacement. "This study further demonstrates both early and late benefits of TAVR that are important to patients who lead active, productive lives."
The SAPIEN 3 TAVR system builds on Edwards' decades of experience in the development of tissue heart valves, and the proven benefits of the Edwards SAPIEN valves.