October 25, 2023 — Edwards Lifesciences announced new data from the PARTNER 3 trial demonstrating continued low rates of all-cause mortality, disabling stroke and rehospitalization at five years. These data, which represent the longest clinical follow-up for a low surgical risk cohort of transcatheter aortic valve replacement (TAVR) patients, were presented during a late-breaking clinical trials session at the 35th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, and published simultaneously in The New England Journal of Medicine.
Analysis of five-year data from the PARTNER 3 trial found that rates of all-cause mortality, disabling stroke and rehospitalization remained low and all secondary endpoints were stable and statistically consistent with the surgical control arm, in which more than 70% of patients received an Edwards surgical heart valve.
"The five-year follow-up findings from the PARTNER 3 trial reaffirm the clinical outcome benefits and bioprosthetic valve durability of SAPIEN 3 TAVR as a meaningful alternative to surgical therapy for low-risk severe, symptomatic AS patients," said PARTNER 3 co-principal investigator Martin Leon, MD, Professor of Medicine at Columbia University Irving Medical Center and Founder and Chairman Emeritus of the Cardiovascular Research Foundation.
In the TAVR arm, all-cause mortality was 10%, cardiovascular mortality was 5.5% and disabling stroke was 2.9% at five years. Rehospitalization for this elderly patient population was less than 3% per year over five years. Valve durability indicators were also stable over time with no difference in the incidence of bioprosthetic valve failure related to structural valve deterioration (1.4% vs. 2.0%) or reintervention rates (2.6% vs. 3.0%) between TAVR and SAVR.
"The SAPIEN 3 valve has demonstrated 99% freedom from death and disabling stroke at one year, 90% survival at five years, and is the only valve with a THV-in-THV indication," said Larry Wood, Edwards' corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. "These data add to the robust body of clinical evidence that shows the versatility and durability of the SAPIEN 3 valve, highlighted by 10 approved indications and the real-world experience in the treatment of over one million patients worldwide, who have benefited from the design of a valve intended for true lifetime management."
The PARTNER 3 trial randomized 1,000 low surgical risk patients at 71 centers between March 2016 and October 2017. Patients were assigned to undergo either TAVR with the SAPIEN 3 valve or surgery with any commercially available surgical valve, with the primary endpoint of all-cause mortality, all-stroke and rehospitalization. One-year clinical results from the PARTNER 3 trial were presented in 2019 and published in The New England Journal of Medicine.
For more information: https://www.edwards.com/
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