EARLY TAVR update: New data highlight continued benefits of treating asymptomatic aortic stenosis
Transcatheter aortic valve replacement (TAVR) with a balloon-expandable transcatheter heart valve is associated with key benefits after five years in patients with asymptomatic severe aortic stenosis (AS), according to updated EARLY TAVR data.
Philippe Généreux, MD, the study’s lead investigator and director of the structural heart program at Morristown Medical Center’s Gagnon Cardiovascular Institute, presented the new findings at New York Valves 2026. He said his team’s findings support the prompt treatment of asymptomatic severe AS instead of waiting for symptoms to develop.
An influential trial
EARLY TAVR has been one of cardiology’s most closely watched clinical trials for many years now. The randomized study funded by Edwards Lifesciences included data from 901 patients 65 years old or older with asymptomatic severe AS who were either underwent transfemoral TAVR with a Sapien 3 TAVR valve from Edwards or clinical surveillance.
Initial results from EARLY TAVR, presented at TCT 2024, highlighted the safety and effectiveness of an early treatment strategy. Many experts believed the trial would be a potential game-changer—and those predictions appear to have largely come true. The trial influenced the FDA’s decision to approve certain Edwards valves for treating asymptomatic patients, and it helped guide significant updates to long-established Medicare policies.
New data highlights long-term value of early treatment
Overall, after a median follow-up period, the composite endpoint of all-cause mortality, stroke or heart failure hospitalization was seen in 15.2% of TAVR patients and 24.2% of early surveillance patients.
In the first two years after treatment, Généreux explained, TAVR was linked to a significant reduction in the risk of heart failure hospitalization compared to clinical surveillance only. These new data, which go beyond the first two years, point to the fact that early treatment appears to significantly reduce the risk of all-cause mortality and stroke as well.
Edwards issued a statement about EARLY TAVR and other new data shared at New York Valves 2026.
“Edwards remains focused on addressing the significant unmet needs of the many structural heart patients who remain untreated today,” Bernard Zovighian, the company’s CEO, said in the statement.
Some clinicians remain skeptical about treating asymptomatic patients
The concept of performing TAVR on patients with asymptomatic severe AS is not universally accepted by all physicians. Some have made the argument that following through with any treatment before symptoms arise creates risks that could otherwise be avoided. There is also a belief among cardiac surgeons that surgery remains a more dependable treatment option for patients who have not yet developed symptoms.
However, with the FDA approving asymptomatic TAVR with select valves and Medicare now proposing full coverage for early treatment, the trend is likely to only gain more momentum as time goes on.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.