SAN
FRANCISCO, Oct. 24, 2023 /PRNewswire/ -- Edwards
Lifesciences (NYSE: EW) today announced new data from the PARTNER 3
trial demonstrating continued low rates of all-cause mortality,
disabling stroke and rehospitalization at five years. These data,
which represent the longest clinical follow-up for a low surgical
risk cohort of transcatheter aortic valve replacement (TAVR)
patients, were presented during a late-breaking clinical trials
session at the 35th Transcatheter Cardiovascular Therapeutics
(TCT), the annual scientific symposium of the Cardiovascular
Research Foundation, and published simultaneously in The New
England Journal of Medicine.
Analysis of five-year data from the PARTNER 3 trial found that
rates of all-cause mortality, disabling stroke and
rehospitalization remained low and all secondary endpoints were
stable and statistically consistent with the surgical control arm,
in which more than 70% of patients received an Edwards surgical
heart valve.
"The five-year follow-up findings from the PARTNER 3 trial
reaffirm the clinical outcome benefits and bioprosthetic valve
durability of SAPIEN 3 TAVR as a meaningful alternative to surgical
therapy for low-risk severe, symptomatic AS patients," said PARTNER
3 co-principal investigator Martin
Leon, MD, Professor of Medicine at Columbia University Irving Medical Center and
Founder and Chairman Emeritus of the Cardiovascular Research
Foundation.
In the TAVR arm, all-cause mortality was 10%, cardiovascular
mortality was 5.5% and disabling stroke was 2.9% at five years.
Rehospitalization for this elderly patient population was less than
3% per year over five years. Valve durability indicators were
also stable over time with no difference in the incidence of
bioprosthetic valve failure related to structural valve
deterioration (1.4% vs. 2.0%) or reintervention rates (2.6% vs.
3.0%) between TAVR and SAVR.
"The SAPIEN 3 valve has demonstrated 99% freedom from death and
disabling stroke at one year, 90% survival at five years, and is
the only valve with a THV-in-THV indication," said Larry Wood, Edwards' corporate vice president
and group president, transcatheter aortic valve replacement and
surgical structural heart. "These data add to the robust body of
clinical evidence that shows the versatility and durability of the
SAPIEN 3 valve, highlighted by 10 approved indications and the
real-world experience in the treatment of over one million patients
worldwide, who have benefited from the design of a valve intended
for true lifetime management."
The PARTNER 3 trial randomized 1,000 low surgical risk patients
at 71 centers between March 2016 and
October 2017. Patients were assigned
to undergo either TAVR with the SAPIEN 3 valve or surgery with any
commercially available surgical valve, with the primary endpoint of
all-cause mortality, all-stroke and rehospitalization. One-year
clinical results from the PARTNER 3 trial were presented in 2019
and published in The New England Journal of Medicine.
Dr. Leon is a consultant to Edwards Lifesciences.
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, Twitter 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.
These forward-looking statements 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, PARTNER,
PARTNER 3, Edwards SAPIEN, Edwards SAPIEN 3, SAPIEN and SAPIEN 3
are trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
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SOURCE Edwards Lifesciences Corporation