CHICAGO, April 2, 2016 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in
patient-focused innovations for structural heart disease and
critical care monitoring, today announced that the randomized
PARTNER II Trial comparing the SAPIEN XT valve to surgery in
intermediate-risk patients successfully achieved its primary
endpoint at two years. The results of the study were
presented as part of the late-breaking clinical trials at the
American College of Cardiology's 65th Annual Scientific
Session (ACC.16) in Chicago, and
simultaneously published online in The New England Journal of
Medicine.
The PARTNER II Trial is the first randomized clinical trial
comparing outcomes of severe, symptomatic aortic stenosis patients
who were at intermediate risk for open-heart surgery. The
composite primary endpoint of the trial was all-cause mortality or
disabling stroke at two years. The event rate was 19.3
percent for transcatheter aortic valve replacement (TAVR) with the
SAPIEN XT valve, which was non-inferior, compared with 21.1 percent
for surgery. For the 76 percent of SAPIEN XT patients
receiving the transfemoral approach, the as-treated event rate was
16.3 percent, which was superior to surgery (p=0.04).
"The PARTNER II Trial is unique in size, distinctive in rigor of
execution and exceptional in patient outcomes," said Craig Smith, M.D., chair, Department of Surgery,
and surgeon-in-chief, NewYork-Presbyterian Hospital/Columbia University Medical Center. Smith is
the co-principal investigator of the PARTNER II Trial. "In
intermediate-risk patients, transcatheter and surgical valve
replacements were similar with respect to the combination of
mortality and disabling stroke. In this study, TAVR significantly
shortened ICU and hospital stays, and, in patients who are
candidates for transfemoral access, the SAPIEN XT valve may have
additional clinical advantages."
The PARTNER II Trial randomized 2,032 patients at 57 centers in
the United States and Canada between December
2011 and November 2013.
Patients were stratified into the transfemoral or
transapical/transaortic cohorts and then randomly assigned to
undergo either transcatheter aortic valve replacement with the
SAPIEN XT valve or surgical aortic valve replacement with any
commercially available surgical valve. All patients were
followed for at least two years. Strokes were assessed by a
neurologist.
Data on intermediate-risk patients treated with the advanced
SAPIEN 3 valve – with comparisons to surgical patients treated in
the PARTNER II A Trial via a pre-specified propensity-score model –
will be presented tomorrow during the joint ACC/TCT late-breaking
clinical trials session. The SAPIEN XT valve and, more
recently, the SAPIEN 3 valve, are approved in the United States for the treatment of
high-risk patients with severe, symptomatic aortic stenosis; the
valves are not approved for the treatment of intermediate-risk
patients. The SAPIEN family of valves has been used in the
treatment of more than 150,000 patients globally.
About Edwards Lifesciences
Edwards Lifesciences, based in Irvine,
Calif., is the global leader in patient-focused medical
innovations for structural heart disease, as well as critical care
and surgical monitoring. Driven by a passion to help
patients, the company collaborates with the world's leading
clinicians and researchers to address unmet healthcare needs,
working to improve patient outcomes and enhance lives. For more
information, visit www.Edwards.com and follow us on Twitter
@EdwardsLifesci.
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, Dr. Smith's statements
and statements regarding expected product features, risks and
benefits. 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.
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, unanticipated outcomes
following longer term clinical experience with the product; or
unanticipated quality, manufacturing 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,
2015. 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 XT, Edwards SAPIEN 3, PARTNER, PARTNER II,
SAPIEN, SAPIEN XT, 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