The RHEIA Trial is investigator-initiated and supported by Edwards. Credit: PeopleImages.com – Yuri A / Shutterstock.

Edwards Lifesciences has reported positive one-year results from the RHEIA Trial, which focused on transcatheter aortic valve implantation (TAVI) in women.

The trial, the first to focus exclusively on female patients, compared the outcomes of those receiving Edwards SAPIEN 3 or SAPIEN 3 Ultra valves to surgical aortic valve replacement (SAVR).

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The study reported a lower rate of death, stroke, or rehospitalisation at 8.9% for TAVI patients, compared to 15.6% for those undergoing SAVR.

It included 443 female subjects with an average age of 73 and was conducted across 48 sites in 12 European countries.

It aimed to assess the performance of Edwards TAVI valves in a diverse female patient population with severe symptomatic aortic stenosis.

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Edwards transcatheter aortic valve replacement and surgical structural heart corporate vice-president and group president Larry Wood said: “We are proud of this high-quality clinical research to inform patients’ decisions about the treatment of their heart valve failure.

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“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.”

The RHEIA Trial is a landmark study, being both investigator-initiated and supported by Edwards.

University Hospital of Rouen cardiology head Hélène Eltchaninoff said: “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.

“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.”