Edwards SAPIEN 3 Valve Shows Excellent Results At 2 Years
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 |
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 |
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 |
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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.
SOURCE Edwards Lifesciences Corporation
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