Edwards’ Sapien 3 TAVR System Evaluated at 5 Years in PARTNER 3 Trial

October 24, 2023—Edwards Lifesciences announced new data from the PARTNER 3 trial demonstrating continued low rates of all-cause mortality, disabling stroke, and rehospitalization at 5 years with the company’s Sapien 3 device for transcatheter aortic valve replacement (TAVR) in a low surgical-risk cohort of patients.

Martin Leon, MD, the PARTNER 3 coprincipal investigator, presented in late-breaking clinical trials session at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California.

Dr. Leon, who is Professor of Medicine at Columbia University Irving Medical Center in New York, New York is also the Founder and Chairman Emeritus of the Cardiovascular Research Foundation, the host and organized to the TCT symposium.

The 5-year study findings were published simultaneously by Michael J. Mack, MD, et al online in The New England Journal of Medicine.

According to Edwards, analysis of the 5-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 5-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 aortic stenosis patients,” commented Dr. Leon in Edwards’ press release.

As summarized by Edwards, the TAVR arm demonstrated rates of all-cause mortality of 10%, cardiovascular mortality of 5.5%, and disabling stroke of 2.9% at 5 years. Rehospitalization for this elderly patient population was < 3% per year over 5 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 company noted that 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.

The 1-year clinical results from the PARTNER 3 trial were presented in 2019 and published by Dr. Mack et al in The New England Journal of Medicine (2019; 380:1695-1705).