Edwards Lifesciences (NYSE: EW) + today announced positive results from its RHEIA trial focused on outcomes for women receiving aortic heart valves.

Investigators presented one-year results from RHEIA during the ESC Congress 2024 in London. They reported superior outcomes for women receiving transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR). The study looked at women who received either the Edwards Sapien 3 or Sapient 3 Ultra valves.

This marks the latest significant Edwards effort to evaluate heart vavle replacements in women. In June, the company announced data supporting the use of its transcatheter aortic valve replacement (TAVR) in women. The study looked at the outcomes of TAVR from those trials in patients with small annulus, with a focus on women.

“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 Dr. Hélène Eltchaninoff, 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.”

More about the study of Edwards valves

Edwards said the independently-run RHEIA trial included 443 female patients with an average age of 73 years old. Investigators randomized patients to TAVI or SAVR to investigate the outcomes in a population with severe symptomatic aortic stenosis. The investigator-initiated, Edwards-supported trial took place across 48 sites in 12 EUropean countries.

At one year, TAVR recorded superiority to SAVR, with 8.9% of TAVI patients experiencing death, stroke or rehospitalization. That compared to 15.6% in the SAVR cohort.

“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’ VP 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.”