Results Published in the New England Journal of Medicine
Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, announced that the results of the randomized PARTNER 3 Trial demonstrated superiority for the SAPIEN 3 transcatheter aortic valve over outcomes with surgery.
The trial, which compared treatment with the SAPIEN 3 valve to surgery in patients with severe symptomatic aortic stenosis (AS) at low risk of death from surgery, achieved superiority of its primary endpoint at one year. The results of the trial were presented at the American College of Cardiology’s 68th Annual Scientific Session (ACC.19) in New Orleans and have been published online in the New England Journal of Medicine.
The PARTNER 3 Trial was an independently evaluated, randomized clinical trial comparing outcomes between transcatheter aortic valve replacement (TAVI) and open-heart surgery in this patient group. TAVI with the SAPIEN 3 valve achieved superiority, with a 46 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 one year.
“TAVI has revolutionized the treatment of aortic stenosis in the last decade and is already accepted as an excellent alternative to open heart surgery in high and intermediate risk patients but without a doubt this is the trial that is most striking and most likely to change practice worldwide” said Professor Philip MacCarthy, Professor of Interventional Cardiology and Consultant Cardiologist, King’s College London and King’s College Hospital, London. “Surgery had excellent results in low risk patients (2.5% mortality and 3.1% stroke rate at 1 year), but TAVI had even better results (1.0% and 1.2% respectively). In addition, previous TAVI limitations in other PARTNER trials such as residual aortic regurgitation, pacemaker requirement and vascular complications were equal in both arms in PARTNER 3. So, the current data suggests that TAVI is a less invasive technique with equal or better results across the whole spectrum of patients. This is an incredible advance in the care of patients with aortic stenosis and I have no doubt that TAVI will become the standard of care for the vast majority of our patients.”
The PARTNER 3 Trial randomized 1,000 patients at 71 centers between March 2016 and October 2017. Patients were assigned to undergo either TAVI with the SAPIEN 3 valve or surgery with any commercially available surgical valve. All patients were followed for at least one year, and 10-year clinical and echocardiographic follow-up is planned for all patients.
“These data demonstrate that TAVI with the SAPIEN 3 valve gives low surgical risk patients with severe AS a treatment with better outcomes, less time in the hospital and the ability to resume their everyday lives more quickly,” said Larry Wood, corporate vice president, transcatheter aortic valve replacement. “It is also highly encouraging to see that 96 percent of TAVI patients were discharged to home as opposed to remaining in a hospital or specialized care setting.”
More than 600,000 patients around the world have benefited from TAVI. The SAPIEN 3 valve has CE Mark for the treatment of intermediate and higher risk patients with severe, symptomatic AS; it is not yet approved for the treatment of low-risk patients.
| Endpoint | 30 Days | p-value‡ | 1 Year | p-value‡ | ||
| TAVI (N=496) SAVR(N=454) | TAVI (N=496) SAVR(N=454)
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| All-cause death, all stroke, and rehospitalization | 4.2% | 9.3% | 0.002 | 8.5% | 15.1% | 0.001 |
| All-cause death | 0.4% | 1.1% | 0.21 | 1.0% | 2.5% | 0.09 |
| All stroke | 0.6% | 2.4% | 0.02 | 1.2% | 3.1% | 0.04 |
| Death or disabling stroke | 0.4% | 1.3% | 0.12 | 1.0% | 2.9% | 0.03 |
| Rehospitalization† | 3.4% | 6.5% | 0.04 | 7.3% | 11.0% | <0.05 |
| † 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 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.
