Edwards SAPIEN 3 TAVR Demonstrates Clinical Superiority To Surgery In PARTNER II Study
Trial Studied Severe, Symptomatic Aortic Stenosis Patients at Intermediate Risk for Surgery
CHICAGO, April 3, 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 new data on patients at intermediate risk for open-heart surgery demonstrated that transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve was superior to surgery at one year on a composite primary endpoint of mortality, stroke and moderate or severe aortic regurgitation. In addition, the SAPIEN 3 valve demonstrated clinical superiority at one year on individual assessments of all-cause mortality and of stroke. The results of the study of 1,078 enrolled patients with severe, symptomatic aortic stenosis 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 Lancet.
"Results from the PARTNER II Trial presented at ACC should establish the SAPIEN 3 valve as the new benchmark for the treatment of intermediate-risk patients with severe, symptomatic aortic stenosis," said Vinod Thourani, M.D., co-director, Structural Heart and Valve Center of the Emory Heart and Vascular Center, chief of cardiothoracic surgery at Emory Hospital Midtown and professor of surgery, Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine. Thourani is the co-principal investigator of the SAPIEN 3 study. "The size and rigor of this 3,000-patient PARTNER II Trial provide powerful evidence in favor of this therapy for the treatment of patients with aortic stenosis."
From February 2014 through September 2014, 1,078 intermediate-risk patients were enrolled in the SAPIEN 3 study at 51 sites in the United States and Canada. One-year SAPIEN 3 outcomes were compared with one-year surgical outcomes from 944 intermediate-risk patients treated with surgery in the PARTNER II randomized trial. Important clinical measures from the study are presented in the table below.
Clinical Outcomes from The PARTNER II Intermediate-Risk Trial with the SAPIEN 3 Valve (As-Treated)*:
| 30 Days |
1 Year |
|||
| Clinical Outcomes (As-Treated) |
SAPIEN 3 |
Surgery |
SAPIEN 3 |
Surgery |
| Death: |
||||
| Death: all-cause - % |
1.1 |
4.0 |
7.4 |
13.0 |
| Death: cardiovascular - % |
0.9 |
3.1 |
4.5 |
8.1 |
| Neurological Events: |
||||
| Stroke: all - % |
2.7 |
6.1 |
4.6 |
8.2 |
| Stroke: disabling - % |
1.0 |
4.4 |
2.3 |
5.9 |
| All-cause Death and Disabling Stroke |
2.0 |
8.0 |
8.4 |
16.6 |
*In a pre-specified propensity-score analysis developed in partnership with the FDA, outcomes from the SAPIEN 3 TAVR patient cohort were compared with outcomes from the surgical arm of the PARTNER II A Trial.
** The full PARTNER II Trial two-year results of intermediate-risk patients were presented at ACC on April 2, and published online in The New England Journal of Medicine.
Moderate or severe aortic regurgitation was 0.6 percent for surgery which was superior to the 1.5 percent for TAVR at one year.
The SAPIEN 3 valve was approved by the U.S. Food and Drug Administration in June 2015 for the treatment of high-risk patients with severe, symptomatic aortic stenosis; the valve is not approved for the treatment of intermediate-risk patients in the U.S. The company has been planning for a U.S. approval late this year. More information on financial guidance and timing will be available during the company's earnings call April 26. The SAPIEN family of valves has been used in the treatment of more than 150,000 patients globally.
Investor Event
Edwards is conducting an investor event Sunday, April 3, 2016, at 6:30 p.m. Eastern/5:30 p.m. Central. This event will be accessible via live webcast at http://ir.edwards.com and available for replay on the "Investor Relations" section of the Edwards web site.
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. Thourani's statements and statements regarding expected timing for regulatory approvals and impact on financial results, as well as 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, unexpected delays or changes in regulatory approval decisions; unanticipated delays of the new product indication launch or in 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 3, PARTNER, PARTNER II, 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
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