CLINICAL QUESTION: In patients with asymptomatic severe aortic stenosis (AS) and preserved ejection fraction (EF), will early-intervention transcatheter aortic-valve replacement (TAVR), compared to clinical surveillance, improve outcomes?
BACKGROUND: Clinical guidelines currently recommend aortic valve replacement for patients with symptomatic severe AS or asymptomatic severe AS with an EF less than 50%. Routine surveillance every six to 12 months is recommended for patients with asymptomatic severe AS and preserved EF. Randomized data to support earlier intervention with TAVR in this population is limited.
STUDY DESIGN: Multicenter, open-label, randomized, controlled study
SETTING: 75 sites across the U.S. and Canada enrolled patients between March 2017 and December 2021. Eligible patients were 65 years old or older with asymptomatic severe AS and preserved EF. Patients with class I indications for valve replacement or high surgical risk were excluded.
SYNOPSIS: A total of 901 patients were randomized: 455 to early TAVR and 446 to routine clinical surveillance. The average age was 75.8 years, 94.9% were white, and 83.6% of patients were at low surgical risk. Over a median follow-up of 3.8 years, the primary composite endpoint of death, stroke, or unplanned hospitalization for cardiovascular (CV) causes occurred in 122 patients (26.8%) in the TAVR arm versus 202 patients (45.3%) in the surveillance arm (hazard ratio, 0.50, 95% confidence interval, 0.40 to 0.63; P <0.001). This difference was mostly driven by unplanned hospitalization for CV causes (20.9% versus 41.7%), and there was no significant difference in death between the two groups (8.4% versus 9.2%). Of note, 87% of patients in the surveillance arm eventually underwent valve replacement with no significant difference in procedural adverse events. The trial’s main limitation is generalizability, as the trial specifically studied low-surgical-risk, elderly, and majority-white patients. Also, only balloon-expandable valves were used, so results may not apply to other valve types or surgical valve replacements.
BOTTOM LINE: In asymptomatic severe aortic stenosis, early TAVR significantly reduced the composite outcome of death, stroke, or unplanned cardiovascular hospitalization compared to guideline-recommended clinical surveillance.
CITATION: Généreux P, et al. Transcatheter aortic-valve replacement for asymptomatic severe aortic stenosis. N Engl J Med. 2025;392(3):217-227. doi: 10.1056/NEJMoa2405880.
Dr. Gronowitz is a hospitalist and instructor of medicine at Columbia University’s Milstein Hospital in New York.