FIRST ALL-FEMALE TAVI TRIAL SHOWS EXCELLENT OUTCOMES FOR WOMEN RECEIVING EDWARDS VALVES
Edwards Lifesciences (NYSE: EW) today announced the results from the RHEIA Trial, a first-of-its-kind trial focused exclusively on outcomes for women receiving transcatheter aortic valve implantation (TAVI). Presenting one-year results during a Hot Line session at the ESC Congress 2024, investigators reported superior outcomes for women receiving the Edwards SAPIEN 3 or SAPIEN 3 Ultra valves as compared to those receiving surgical aortic valve replacement (SAVR).
"Women are an underrepresented group in the diagnosis and treatment of severe aortic stenosis and this landmark study provides important insights into their treatment options," said Hélène Eltchaninoff, M.D., head of the department of cardiology at the University Hospital of Rouen. "The transcatheter and surgical arms achieved remarkable results and the performance of the transcatheter valves adds to a growing body of evidence on the treatment options available to women."
In the evaluation of composite 1-year endpoints, TAVI was found to be superior to SAVR with 8.9% of TAVI patients experiencing death, stroke or rehospitalization versus 15.6% in the SAVR cohort. The independently run RHEIA Trial included 443 female patients with an average age of 73, randomized to TAVI or SAVR to investigate outcomes of Edwards TAVI compared to surgery in an all-comers female patient population suffering from severe symptomatic aortic stenosis. The RHEIA Trial, which was investigator initiated and supported by Edwards, was conducted across 48 sites in 12 European countries.
"We are proud of this high-quality clinical research to inform patients' decisions about the treatment of their heart valve failure," said Larry Wood, Edwards' corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. "The outstanding success of the TAVI group points to the importance of valve selection for women undergoing aortic valve replacement especially those women with small annuli to preserve their options for a future valve-in-valve procedure, ensuring the lifetime management of their disease."
Correcting the valve attribution from SAPIEN 3 Ultra RESILIA to SAPIEN 3 and correcting the patient population from 440 to 443. No further corrections were made.
About Edwards Lifesciences
Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on Facebook, Instagram, LinkedIn and YouTube.
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