FDA Approves TAVI for Asymptomatic Patients With Severe Aortic Stenosis

Asymptomatic patients with severe aortic stenosis can now undergo transcatheter aortic valve replacement, thanks to the US Food and Drug Administration’s approval of the new indication for the balloon-expandable Sapien 3 platform, device maker Edwards Lifesciences announced today.

The approval is based on results from the 901-patient EARLY TAVR trial led by Philippe Généreux, MD (Morristown Medical Center, NJ).

Published last year in the New England Journal of Medicine and reported by TCTMD at that time, the study showed that treating patients who had severe aortic stenosis but no symptoms with TAVI halved the risk of a composite endpoint of death, stroke, or unplanned cardiovascular hospitalizations over nearly 4 years of follow-up when compared with watchful waiting (HR 0.50; 95% CI 0.40-0.63).

The benefit was driven by a reduction in unplanned hospitalizations, which included the need for aortic valve replacement in the first 6 months. By 2 years, more than 70% of patients in the watchful-waiting group underwent TAVI due to worsening symptoms. Safety outcomes were similar in the two groups, with early intervention not associated with a heightened risk of cardiovascular mortality in the first 30 days.

Current clinical guidelines recommend routine surveillance every 6 to 12 months in patients with asymptomatic severe aortic stenosis.