First All-Female TAVI Trial Shows Excellent Outcomes for Women Receiving Edwards Valves

Rhea-AI Summary

Edwards Lifesciences (NYSE: EW) announced results from the RHEIA Trial, the first all-female study comparing transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR). The trial, involving 440 women with an average age of 73, showed superior outcomes for TAVI using Edwards SAPIEN 3 Ultra or SAPIEN 3 Ultra RESILIA valves compared to SAVR.

Key findings at one-year follow-up:

• TAVI group: 8.9% experienced death, stroke, or rehospitalization
• SAVR group: 15.6% experienced death, stroke, or rehospitalization

The study, conducted across 48 sites in 12 European countries, aims to address the underrepresentation of women in aortic stenosis treatment research and provide insights into their specific treatment options.

Positive

• TAVI showed superior outcomes compared to SAVR in women
• Lower rate of death, stroke, or rehospitalization in TAVI group (8.9%) vs SAVR group (15.6%)
• Study addresses underrepresentation of women in aortic stenosis treatment research
• Potential for improved treatment options for women with small annuli

Negative

• None.

Insights

Medical Research Analyst

The RHEIA Trial marks a significant milestone in cardiovascular research, focusing exclusively on women's outcomes in TAVI procedures. The superior results of TAVI over SAVR (8.9% vs 15.6% composite endpoint) highlight the potential for improved treatment options for women with severe aortic stenosis.

Notably, the study's all-female cohort addresses the historical underrepresentation of women in cardiac trials. This gender-specific data is important for tailoring treatment approaches and could lead to more personalized care strategies. The average age of 73 in the study population also provides valuable insights into the efficacy of TAVI in older female patients.

The trial's multinational nature (48 sites across 12 European countries) enhances its generalizability, potentially influencing global treatment guidelines for women with aortic stenosis.

Cardiology Specialist

The RHEIA Trial's results are groundbreaking for women's cardiovascular care. The superiority of TAVI over SAVR in this female-only study could reshape treatment paradigms. The lower rate of adverse outcomes (death, stroke, rehospitalization) with TAVI suggests it may become the preferred option for many women with severe aortic stenosis.

Of particular interest is the mention of valve selection for women with small annuli. This highlights the importance of considering future valve-in-valve procedures, which is important for long-term disease management. The study's focus on "all-comers" female population also increases its clinical relevance, as it reflects real-world patient demographics.

These findings may lead to updated guidelines favoring TAVI in women, especially those at higher surgical risk or with anatomical considerations like small annuli.

Financial Analyst

This study's results are highly positive for Edwards Lifesciences (NYSE: EW), potentially expanding the market for their SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA valves. The superior outcomes in women could drive increased adoption of TAVI procedures, particularly benefiting Edwards as a market leader.

The focus on women, an underrepresented group in aortic stenosis treatment, opens up a significant market segment. This could lead to increased sales and market share for Edwards' TAVI products. Moreover, the emphasis on valve selection for potential future valve-in-valve procedures suggests a long-term revenue stream from follow-up treatments.

Investors should note that this study might influence treatment guidelines, potentially accelerating the shift from surgical to transcatheter approaches in aortic valve replacement. This trend aligns with Edwards' strategic focus and could drive sustained growth in their TAVI business segment.

LONDON--(BUSINESS WIRE)-- 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 Ultra or SAPIEN 3 Ultra RESILIA 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 440 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.”

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.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend the forward-looking statements contained in this Proxy Statement to be covered by the safe harbor provisions of such Acts. These forward-looking statements can sometimes be identified by the use of forward-looking words, such as “may,” “might,” “believe,” “will,” “expect,” “project,” “estimate,” “should,” “anticipate,” “plan,” “goal,” “continue,” “seek,” “intend,” “optimistic,” “aspire,” “confident” and other forms of these words and include, but are not limited to, statements made by Mr. Wood and statements regarding expected product benefits, patient outcomes, post-treatment reduction of invasive procedures, objectives and expectations and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, RESILIA, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240831825338/en/

Media Contact: Howard Wright, 949-250-2790

Investor Contact: Mark Wilterding, 949-250-6826

Source: Edwards Lifesciences Corporation

FAQ

What were the key findings of the RHEIA Trial for Edwards Lifesciences (EW)?

The RHEIA Trial showed superior outcomes for women receiving TAVI using Edwards SAPIEN 3 Ultra or SAPIEN 3 Ultra RESILIA valves compared to surgical aortic valve replacement (SAVR). At one-year follow-up, 8.9% of TAVI patients experienced death, stroke, or rehospitalization versus 15.6% in the SAVR group.

How many women participated in the RHEIA Trial for Edwards Lifesciences (EW)?

The RHEIA Trial included 440 female patients with an average age of 73, randomized to either TAVI or SAVR for the treatment of severe symptomatic aortic stenosis.

Where was the RHEIA Trial for Edwards Lifesciences (EW) conducted?

The RHEIA Trial was conducted across 48 sites in 12 European countries. It was an investigator-initiated study supported by Edwards Lifesciences.

What is the significance of the RHEIA Trial for Edwards Lifesciences (EW)?

The RHEIA Trial is the first-of-its-kind study focused exclusively on outcomes for women receiving transcatheter aortic valve implantation (TAVI). It addresses the underrepresentation of women in aortic stenosis treatment research and provides important insights into their specific treatment options.