Edwards Lifesciences (NYSE: EW) announced new data demonstrating continued positive outcomes with its Sapien 3 transcatheter aortic valve replacement (TAVR).
Results from the PARTNER 3 trial showed continued low rates of all-cause mortality, disabling stroke and rehospitalization at five years. Edwards presented the data at the 35th Transcatheter Cardiovascular Therapeutics (TCT) in San Francisco. It simultaneously published results in The New England Journal of Medicine. The study represents the longest clinical follow-up for a low-surgical-risk TAVR cohort.
Analysis of five-year data found that mortality, stroke and rehospitalization rates remained low with stable secondary endpoints. Results remained statistically consistent with the surgical control arm, in which more than 70% of patients received an Edwards surgical heart valve.
Study co-principal investigator Dr. Martin Leon said the results reaffirm the clinical outcome benefits and valve durability of Sapien 3. Leon serves as a professor of medicine at Columbia University Irving Medical Center.
The data from Edwards
PARTNER 3 randomized 1,000 low-surgical-risk patients across 71 centers between March 2016 and October 2017. Patients either underwent TAVR with Sapien 3 or surgery with any other commercially available surgical valve.
Investigators set a primary endpoint of all-cause mortality, all-stroke and rehospitalization. Edwards shared one-year results in 2019.
In the TAVR arm, all-cause mortality came in at 10%, with cardiovascular mortality at 5.5%. Disabling stroke totaled 2.9% at five years, with rehospitalization for an elderly patient population coming in at less than 3%. Valve durability indicators also proved stable over time.
Edwards saw no difference in the incidence of bioprosthetic valve failure related to structural valve deterioration (1.4% vs. 2%). Reintervention rates also proved minimally different (2.6% vs. 3%) 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 VP and group president, TAVR 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.”
