Edwards Lifesciences announces new data from PARTNER 3 trial
Edwards Lifesciences announced new data demonstrating early and sustained health status advantages for severe aortic stenosis 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 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 at 1 month. 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 and 1 year. 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. 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% 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.