Edwards Lifesciences Touts Positive Results in First All-Female TAVI Trial

Transcatheter aortic valve implantation (TAVI) seems to be a better option for women seeking treatment for severe aortic stenosis, according to new study results.

Investigators with the RHEIA Trial are reporting superior outcomes for females receiving the Edwards SAPIEN 3 or SAPIEN 3 Ultra valves as compared to those receiving surgical aortic valve replacement (SAVR). The study—orchestrated by Edwards Lifesciences—is the first to focus exclusively on outcomes for women receiving TAVI. 
 
“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 one-year endpoints, TAVI was found to be superior to SAVR with 8.9% of TAVI patients experiencing death, stroke or rehospitalization compared with 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.

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READ MORE: Studies Support Favorable Outcomes With Edwards’ SAPIEN TAVR

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“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 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.”
 
Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. The company is based in Irvine, Calif.