First All-Female TAVI Trial Shows Excellent Outcomes for Women Receiving Edwards Valves
2024年9月1日 - 1:35AM
ビジネスワイヤ(英語)
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.
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but are not limited to, statements made by Mr. Wood and statements
regarding expected product benefits, patient outcomes,
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Forward-looking statements are based on estimates and assumptions
made by management of the company and are believed to be
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on which they are made, and we do not undertake any obligation to
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Forward-looking statements involve risks and uncertainties that
could cause results to differ materially from those expressed or
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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,
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Media Contact: Howard Wright, 949-250-2790 Investor Contact:
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