Age and Procedural Timing for Asymptomatic Severe Aortic Stenosis: Analysis From the EARLY TAVR Trial

The EARLY TAVR trial (Evaluation of TAVR Compared to Surveillance for Patients with Asymptomatic Severe Aortic Stenosis) demonstrated that early transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance (CS) in asymptomatic severe aortic stenosis. The relative impact of early TAVR versus CS strategy by age is unknown.

The study population of the EARLY TAVR trial was stratified into 4 age groups: 65 to 69 years (n=141), 70 to 74 years (n=263), 75 to 79 years (n=250), and ≥80 years (n=247). Associations between age and the trial primary end point of death, stroke, or unplanned cardiovascular hospitalization; the composite end point of death, stroke, or heart failure hospitalization; and its individual components were examined. Interaction tests evaluated whether the treatment effect of early TAVR versus CS differed by age.

No interaction was detected between age and the treatment effect of early TAVR versus CS for the composites or individual outcomes. We observed lower stroke rates with early TAVR compared with CS in the youngest (65-69 years, absolute risk reduction, 13%; P=0.008) and oldest (≥80 years; absolute risk reduction, 12.3%; P=0.029) age groups. The absolute difference in heart failure hospitalization rates between the early TAVR and CS arms at 2 years was greatest in the oldest patients (≥80 years, 9.1%; 75-79 years, 5.9%; 70-74 years, 5.1%; 65-69 years, 4.4%). In the CS group, time to conversion to AVR was similar across all age groups (median, 11 months; P=0.73). Approximately one-third of younger patients (65-69 years) in the CS arm presented with acute valve syndrome at the time of conversion, the frequency of which tended to increase with age (P=0.06).

In the EARLY TAVR trial, the relative benefit of early TAVR over CS was consistent among all age groups. The greatest absolute reduction in stroke rate with early TAVR compared with CS appeared in the youngest and oldest groups, whereas reduction in heart failure hospitalization was most pronounced in the oldest patients. These data suggest that early TAVR should be considered in all age groups above 65 years.

URL: https://www.clinicaltrials.gov; Unique identifier: NCT03042104.