5-Year Data Backs Edwards’ Sapien 3 TAVR

Edwards Lifesciences released new data from its PARTNER 3 trial data at the Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation.
 
The data, according to the company, is the longest clinical follow-up for a low surgical risk cohort of transcatheter aortic valve replacement (TAVR) patients. Five-year data from the trial showed rates of all-cause mortality, disabling stroke, and rehospitalization remained low.
 
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 incidence of bioprosthetic valve failure related to structural valve deterioration (1.4% vs. 2%) or reintervention rates (2.6% vs. 3.0%) between TAVR and SAVR (surgical aortic valve replacement).
 
“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,” Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart, told the press. “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.