PARTNER 3 trial of Sapien 3 valve for aortic stenosis published in Journal of American College of Cardiology.- Edwards Lifesciences

Edwards Lifesciences 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. 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.

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.

See: "Health Status after Transcatheter vs. Surgical Aortic Valve Replacement in Low-Risk Patients with Aortic Stenosis" Suzanne J. Baron et al. Journal of the American College of Cardiology September 2019 DOI: 10.1016/j.jacc.2019.09.007