Among patients with asymptomatic severe aortic stenosis, just over a quarter  of those who underwent early transcatheter aortic valve replacement experienced death, stroke, or unplanned cardiovascular hospitalization, compared with nearly half who were managed with clinical surveillance at a median follow-up of 3.8 years.

The U.S. Food and Drug Administration (FDA) approved Edwards Lifesciences’ SAPIEN 3 transcatheter aortic valve replacement (TAVR) platform for patients with asymptomatic severe aortic stenosis (AS), marking the first such approval for this patient population. The decision was based on data from the EARLY TAVR trial, a randomized controlled study comparing early intervention using the SAPIEN 3 platform—including SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA—with guideline-directed surveillance.

At a median follow-up of 3.8 years, 26.8% of the 455 patients in the TAVR group experienced a composite endpoint of death, stroke, or unplanned cardiovascular hospitalization, compared with 45.3% of 446 patients assigned to clinical surveillance. These findings were published in The New England Journal of Medicine.

Current guidelines recommend watchful waiting for patients with asymptomatic severe AS. However, according to Philippe Généreux, MD, Director of the sSructural Heart Program at Gagnon Cardiovascular Institute, at Morristown Medical Center, symptom onset in these patients may be abrupt and unpredictable. Dr. Généreux—who was the lead author of The New England Journal of Medicine report on EARLY TAVR—emphasized the need for early multidisciplinary evaluation to potentially improve clinical outcomes.

Larry Wood, Corporate Vice President and Group President of TAVR and Surgical at Edwards Lifesciences, stated the approval of SAPIEN 3 may contribute to streamlined care pathways and greater system efficiency.

The EARLY TAVR trial was the initial randomized controlled study to assess TAVR relative to clinical monitoring in patients with asymptomatic severe AS. The SAPIEN 3 platform's approval adds to the body of evidence supporting early intervention for patients with a condition where symptom recognition can be delayed and prognosis may rapidly decline.

Source: Edwards Lifesciences