News | Cardiovascular Surgery | October 25, 2023

Five-year Data from Partner 3 Trial Demonstrate Excellent Survival for Patients Receiving Edwards Sapien 3 Valve

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

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: 


Find more TCT23 conference coverage here 


Related Content:  

Data from Benchmark Registry Demonstrate Improved TAVR Efficiency with Preserved Patient Safety  

CRF Announces TCT 2023 Late-breaking Clinical Trials  

Edwards Sapien 3 TAVI Granted European Approval to Treat Low-risk Patients  

National Coverage Determination Will Make TAVR Available to More Patients at More Centers  

VIDEO: TAVR Stands Equal to Surgical Valve Replacement — Interview with Michael Reardon, M.D.  

Study Finds TAVR Can Be Considered for Patients in All Surgical Risk Classes  

VIDEO: Edwards Lifesciences Sapien 3 TAVR Procedural Animation  

TAVR Performs Well Compared to Surgical Aortic Valve Replacement in Low Risk Patients  

CMS Finalizes Updates to Coverage Policy for Transcatheter Aortic Valve Replacement  

TAVR Outperforms Surgery in Younger, Low-Risk Aortic Stenosis Patients  

VIDEO: Tracking Transcatheter Valve Outcomes in the STS-ACC TVT Registry — interview with John Carroll, M.D.  

Interventional Imagers: The Conductors of the Heart Team Orchestra  

Boston Scientific Receives FDA Approval for Lotus Edge Aortic Valve System  

Length of Stay Impacts TAVR Outcomes  

VIDEO: TAVR For Asymptomatic Severe Aortic Stenosis — Interview with  Philippe Genereux, M.D.  

How to Perform Transcaval TAVR Access  

The Essentials of Structural Heart Imaging  

Hospital Consolidation May Increase Access to TAVR, New Cardiac Technologies  

VIDEO: Outcomes Following Urgent TAVR - Results from the TVT Registry — Interview with Sammy Elmariah, M.D.  

Valve Replacement Volume Key to Successful Patient Outcomes  

TAVR Operator and Hospital Requirements Outlined in 2018 AATS/ACC/SCAI/STS Expert Consensus  

VIDEO: Overview of University of Colorado Structural Heart Program  

VIDEO: TAVR for Degenerated Surgical Valves, Valve-in-Valve TAVR Procedures — Interview with Sammy Elmariah, M.D.  

VIDEO: Advice For Hospitals Starting a Structural Heart Program — interview with John Carroll, M.D.  

VIDEO: How to Get Referral Patients Into a Structural Heart Program  

Recent Advances in Transcatheter Valve Technology 

Related Content

News | TCT

November 9, 2023 — Medinbox, a global provider of video integrated collaboration systems for interventional rooms and ...

Home November 09, 2023
News | TCT

October 30, 2023 — Shockwave Medical, Inc., which develops technologies for the treatment of cardiovascular disease, has ...

Home October 30, 2023
News | TCT

October 26, 2023 — The Society of Thoracic Surgeons and the European Association for Cardiothoracic Surgeons have issued ...

Home October 26, 2023
News | TCT

October 26, 2023 — A new study presented at TCT 2023 revealed inequities in access to mechanical circulatory support in ...

Home October 25, 2023
News | TCT

October 25, 2023 — Elixir Medical, developer of novel cardiovascular technologies, announced positive six-month clinical ...

Home October 25, 2023
News | TCT

October 25, 2023 — Medtronic plc, a global leader in healthcare technology, announced four-year results from the Evolut ...

Home October 25, 2023
News | TCT

October 25, 2023 — Information on a new double lumen catheter was presented by Nabil Dib, MD, MSc, FACC, FESC, during ...

Home October 25, 2023
News | TCT

October 25, 2023 — For its novel multi-lumen stent system for interventional adjustment of pulmonary blood flow in ...

Home October 25, 2023
Feature | TCT | By Melinda Taschetta-Millane

Innovation. Connection. Inspiration. The Transcatheter Cardiovascular Therapeutics (TCT) 2023 conference, the ...

Home October 20, 2023
News | TCT

October 19, 2023 — OpSens, a medical device cardiology-focused company, has announced that results of the “SAFE-TAVI ...

Home October 19, 2023
Subscribe Now