Early TAVR showed consistent benefit over clinical surveillance across all age groups ≥65 years, with absolute stroke risk reductions of 13% in patients aged 65-69 and 12.3% in those ≥80.
RCT (n=901)
Does early transcatheter aortic valve replacement improve clinical outcomes compared to clinical surveillance in patients with asymptomatic severe aortic stenosis across different age groups?
The relative clinical benefit of early TAVR over clinical surveillance in asymptomatic severe aortic stenosis is consistent across all age groups above 65 years.
BACKGROUND: The EARLY TAVR trial 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 a CS strategy by age is unknown. METHODS: 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. RESULTS: No interaction was detected between age and the treatment effect of early TAVR versus CS for the composite 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, and the frequency tended to increase with age ( P =0.06). CONCLUSIONS: 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. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03042104.
Goel et al. (Wed,) conducted a rct in Asymptomatic severe aortic stenosis (n=901). Early transcatheter aortic valve replacement (TAVR) vs. Clinical surveillance (CS) was evaluated on Death, stroke, or unplanned cardiovascular hospitalization. Early TAVR showed consistent benefit over clinical surveillance across all age groups ≥65 years, with absolute stroke risk reductions of 13% in patients aged 65-69 and 12.3% in those ≥80.