IRVINE, Calif., March 29, 2020 /PRNewswire/
-- Edwards Lifesciences Corporation (NYSE: EW), the
global leader in patient-focused innovations for structural heart
disease and critical care monitoring, today announced 2-year
results of the randomized PARTNER 3 trial comparing treatment with
the SAPIEN 3 valve to surgery in patients with severe symptomatic
aortic stenosis (AS) at low risk of death from surgery.
Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3
valve continued to demonstrate favorable results for low-risk
patients over surgery. TAVR resulted in a 37 percent reduction in
the event rate for the primary endpoint of the trial, which was a
composite of all-cause mortality, all stroke and rehospitalization
at two years. Death and stroke rates were both low between TAVR and
surgical aortic valve replacement (SAVR) at two years, and TAVR
patients experienced a significantly lower rate of
rehospitalization. The results of the trial were presented online
today as part of the late-breaking clinical trials by the American
College of Cardiology's Annual Scientific Session Together with
World Congress of Cardiology (ACC.20/WCC).
"We are encouraged by the results of the PARTNER 3 study,
including the similarly low rates of death and stroke for both TAVR
and SAVR, which continue to build on a robust body of evidence,"
said Michael J. Mack, M.D., chairman
of the cardiovascular service line at Baylor Scott & White
Health and chairman of the board for the Baylor Scott & White
Research Institute. "We are committed to 10-year clinical and
echocardiographic follow-up of patients in this trial, which may
help inform the medical community going forward."
The PARTNER 3 trial randomized 1,000 patients at 71 centers
between March 2016 and October 2017. Low-risk patients were assigned to
undergo either TAVR with the SAPIEN 3 valve or surgery with any
commercially available surgical valve.
"These data demonstrate that TAVR with the SAPIEN 3 valve
continues to perform well at two years, which gives low surgical
risk patients with severe AS the ability to choose a treatment that
factors in their individual priorities in consultation with their
physician," said Larry Wood,
Edwards' corporate vice president, transcatheter aortic valve
replacement.
The SAPIEN 3 valve was approved in August
2019 in the United States
for the treatment of low risk patients with severe, symptomatic AS.
To date, more than 650,000 patients around the world have
benefitted from TAVR.
Endpoint
|
1
Year
|
p-value‡
|
2
Years
|
p-value‡
|
TAVR
(N=496) SAVR (N=454)
|
|
TAVR
(N=496) SAVR (N=454)
|
|
All-cause death,
all
stroke, and
rehospitalization
|
8.5%
|
15.6%
|
<0.001
|
11.5%
|
17.4%
|
0.007
|
All-cause
death
|
1.0%
|
2.5%
|
0.08
|
2.4%
|
3.2%
|
0.47
|
All stroke
|
1.2%
|
3.3%
|
0.03
|
2.4%
|
3.6%
|
0.28
|
Death or
disabling
stroke
|
1.0%
|
3.1%
|
0.02
|
3.0%
|
3.8%
|
0.47
|
Rehospitalization†
|
7.3%
|
11.3%
|
0.04
|
8.5%
|
12.5%
|
0.046
|
† Rehospitalization
(valve-related or procedure-related and including heart
failure)
‡ p-values is based
on a log-rank test
All event rates are
Kaplan-Meier estimates
|
About Edwards Lifesciences
Edwards Lifesciences, based in Irvine, Calif., is the
global leader of patient-focused medical 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 and Section
21E of the Securities Exchange Act of 1934. These forward-looking
statements include, but are not limited to, Mr. Wood's and Dr.
Mack's statements, overall treatment benefits and expected patient
outcomes. 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.
Statements of past performance, efforts, or results about which
inferences or assumptions may be made can also be forward-looking
statements and are not indicative of future performance or results;
these statements can be identified by the use of words such as
"preliminary," "initial," diligence," "industry-leading,"
"compliant," "indications," or "early feedback" or other forms of
these words or similar words or expressions or the negative
thereof. 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, including but not limited to, unexpected delays or changes
in the regulatory approval, unanticipated outcomes of clinical
experience with the product following longer term clinical
experience, or unanticipated manufacturing, legal, quality or
regulatory delays or issues. These factors are detailed in the
company's filings with the Securities and Exchange Commission
including its Annual Report on Form 10-K for the year ended
December 31, 2019. 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, PARTNER, PARTNER 3, SAPIEN, and SAPIEN 3
are trademarks of Edwards Lifesciences Corporation and its
affiliates. All other trademarks are the property of their
respective owners. This statement is made on behalf of Edwards
Lifesciences Corporation and its subsidiaries.
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SOURCE Edwards Lifesciences Corporation