A victory for early treatment: FDA approves first TAVR valves for asymptomatic severe aortic stenosis
The U.S. Food and Drug Administration (FDA) has approved the balloon-expandable Sapien 3 transcatheter aortic valve replacement (TAVR) platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis (AS).
This is the first time the FDA has approved any TAVR technology in asymptomatic patients. The decision covers the Sapien 3, Sapien 3 Ultra and Sapien 3 Ultra Resilia TAVR valves.
“This approval is a powerful opportunity to streamline patient care and improve the efficiency of the healthcare system,” Larry Wood, Edwards’ corporate vice president and group president of TAVR and surgical technologies, said in a statement announcing the news. “We are proud to partner with leading physicians to advance our knowledge of this deadly disease with high quality science and optimize the treatment pathway for patients.”
EARLY TAVR data paved the way for FDA’s decision
Cardiologists have been considering the potential of TAVR in asymptomatic patients for quite some time. A turning point came in late 2024, when late-breaking data from the EARLY TAVR clinical trial was presented at TCT 2024 in Washington, D.C.
Lead investigator Philippe Généreux, MD, announced his team’s findings in front of a packed audience. Attendees cheered and roared with excitement as he revealed the study’s primary outcomes. The data was also simultaneously published in The New England Journal of Medicine.[1]
EARLY TAVR included data from 901 patients 65 years or older who presented with asymptomatic severe AS. Patients were randomized to either receive a Sapien 3 TAVR valve from Edwards Lifesciences or be monitored with clinical surveillance.
The mean patient age was 75.8 years old, 69% were men and the mean Society of Thoracic Surgeons risk score was 1.8%. While a vast majority (83.6%) of patients faced a low surgical risk, the mean Kansas City Cardiomyopathy Questionnaire (KCCQ) score was 92.7, suggesting the cohort presented with a relatively healthy, symptom-free quality of life.
The study’s primary endpoint—a composite of all-cause mortality, stroke or unplanned cardiovascular hospitalizations—was seen in 26.8% of TAVR patients and 45.3% of clinical surveillance patients. This was primarily driven by a significant reduction in unplanned hospitalization—20.9% for TAVR, 41.7% for clinical surveillance—though early treatment was also associated with lower rates of all-cause mortality (8.4% vs. 9.2%) and stroke (4.2% vs. 6.7%).
To gain a better understanding of the benefits of early treatment, Généreux et al. also tracked KCCQ scores two years after randomization. A favorable health status—defined as being alive with a KCCQ score of at least 75 that had not decreased more than 10 points from baseline—was seen in 86.8% of TAVR patients and 68% of clinical surveillance patients.
Another key takeaway from EARLY TAVR was the fact that 87% of patients in the clinical surveillance group had undergone TAVR after a median follow-up period of 3.8 years.
“The world has been waiting on the outcome of this trial,” Prof. Bernard Prendergast, chair of cardiology at Cleveland Clinic London and a consultant with St Thomas’ Hospital in Westminster, England, said from the stage at TCT after Généreux presented the data. He went on to praise EARLY TAVR and suggest early treatment for asymptomatic patients could represent the future of cardiology.
“A major reset in our approach to severe asymptomatic AS is now warranted,” Prendergast said. “The concept of watchful waiting is no longer appropriate and deserves reexamination. Patients require access to earlier diagnoses and they need to be prepared early for their interventional procedure.”
Généreux, director of the structural heart program at the Gagnon Cardiovascular Institute at Morristown Medical Center, also presented additional EARLY TAVR data at ACC.25.
‘An urgent need’ for change
In a new statement, Généreux emphasized that this news could result in significant changes to how cardiologists identify TAVR candidates. Industry guidelines may also need to be reconsidered following the FDA’s decision.
“There is an urgent need to change practice and TAVR guidelines for the treatment of aortic stenosis patients, which currently recommend ‘watchful waiting’ until symptoms develop,” he said. “As we saw in the EARLY TAVR trial, patients originally designated as asymptomatic became symptomatic in sudden and unpredictable ways, underscoring the importance of early evaluation by a heart team to improve patient outcomes and benefit the healthcare system.”
Click here and here to watch two Cardiovascular Business interviews with Généreux about the EARLY TAVR data.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.