FDA Approves TAVR for Asymptomatic Severe Aortic Stenosis Based on EARLY TAVR Trial

In a landmark decision, the FDA  approved the use of Edwards Lifesciences’ SAPIEN 3 transcatheter aortic valve replacement (TAVR) platform for patients with severe aortic stenosis (AS) who are asymptomatic. This marks the first FDA approval of TAVR for patients without symptoms, expanding the therapeutic options for this population.

The approval is grounded in the findings of the EARLY TAVR trial, a randomized, controlled study that compared early TAVR intervention to guideline-recommended clinical surveillance in asymptomatic patients with severe AS. The trial enrolled 901 patients, with 455 assigned to early TAVR and 446 to clinical surveillance. Over a median follow-up of 3.8 years, the composite primary endpoint of death, stroke, or unplanned cardiovascular hospitalization occurred in 26.8% of the TAVR group compared to 45.3% in the surveillance group (hazard ratio [HR], 0.50; 95% confidence interval [CI], 0.40–0.63; P<0.001).

Secondary endpoints also favored early TAVR. Unplanned cardiovascular hospitalizations were significantly lower in the TAVR group (20.9% vs 41.7%), and stroke incidence was reduced (4.2% vs 6.7%). Mortality rates were similar between groups (8.4% TAVR vs 9.2% surveillance). Additionally, patients undergoing early TAVR demonstrated better preservation of left ventricular and left atrial function at 2 years.

Notably, the trial revealed that symptom progression in asymptomatic severe AS patients can be rapid and unpredictable. Approximately 26% of patients in the surveillance group developed symptoms within six months, 50% within a year, and over 70% required aortic valve replacement by two years. Many presented with advanced symptoms such as New York Heart Association class III–IV heart failure, pulmonary edema, or syncope.

Dr. Philippe Généreux, principal investigator of the EARLY TAVR trial, emphasized the clinical implications: “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.”

Treatment of asymptomatic patients with severe aortic stenosis should remain judicious and nuanced when recommending TAVR. The ideal patients are those in whom procedural risk is low (in terms of vascular access, baseline conduction, annular and root anatomic considerations, coronary ostial heights, etc.) and future valve-in-valve options are expected to be feasible without high risk of sinus sequestration or coronary obstruction. These patients should have no other indication for cardiac surgery. Additional data on risk stratification will help aid this decision-making.

With FDA approval, clinicians now have the option to consider early TAVR intervention for asymptomatic patients with severe AS on a case-by-case basis.