Asymptomatic severe aortic stenosis represents an increasingly common clinical challenge. Although current guidelines recommend intervention once symptoms develop or left ventricular dysfunction occurs, concerns remain regarding the risk of sudden death, heart failure, and irreversible myocardial damage during the watchful waiting period.
The EARLY TAVR trial previously demonstrated the superiority of an early TAVR strategy compared with clinical surveillance; however, questions remained as to whether this benefit was consistent across different age groups. This post hoc analysis evaluated the impact of age on the clinical outcomes of early TAVR in patients with asymptomatic severe aortic stenosis.
A total of 901 patients were randomized in a 1:1 ratio to either early TAVR or clinical surveillance. The population was stratified into four age groups: 65–69 years (n=141), 70–74 years (n=263), 75–79 years (n=250), and ≥80 years (n=247). The mean age was 75.8 years, 69.1% were men, and the median follow-up was 3.8 years. All procedures were performed via the transfemoral approach using balloon-expandable SAPIEN 3 or SAPIEN 3 Ultra valves.
The primary endpoint was a composite of all-cause mortality, stroke, or heart failure hospitalization. Individual components of the endpoint, as well as the clinical course of patients initially assigned to clinical surveillance, were also analyzed.
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No significant interaction was observed between age and treatment effect for the primary endpoint (p=0.47), demonstrating a consistent benefit of early TAVR across all age groups. Rates of the primary endpoint per 100 patient-years were 6.2 versus 22.5 (HR 0.40; 95% CI 0.19–0.82) in patients aged 65–69 years; 13.7 versus 21.1 (HR 0.55; 95% CI 0.35–0.86) in those aged 70–74 years; 15.9 versus 34.0 (HR 0.39; 95% CI 0.25–0.60) in patients aged 75–79 years; and 19.6 versus 48.3 (HR 0.55; 95% CI 0.38–0.79) in patients aged ≥80 years. Likewise, no significant interaction was found for the composite of death, stroke, or heart failure (p=0.53).
Mortality did not differ according to age (interaction p=0.81). However, early TAVR was associated with a significant reduction in stroke among patients aged 65–69 years (0 events versus 7; absolute risk reduction 13%; p=0.008) and those aged ≥80 years (absolute risk reduction 12.3%; p=0.029). In addition, the reduction in heart failure hospitalizations was most pronounced in patients aged ≥80 years, with an absolute risk reduction of 9.1% at 2 years and a number needed to treat of 11 patients.
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Among patients assigned to clinical surveillance, the median time to aortic valve replacement was similar across age groups (13.0, 11.0, 9.6, and 11.7 months, respectively; p=0.73). Approximately one-third of patients aged 65–69 years required intervention after experiencing an acute valvular syndrome, a proportion that tended to increase with age (p=0.06).
Conclusion: Early TAVR reduces cardiovascular events in patients with asymptomatic severe aortic stenosis regardless of age
In patients with asymptomatic severe aortic stenosis, the clinical benefit of early TAVR was consistent across all age groups older than 65 years. The reduction in stroke risk was most evident among the youngest and oldest patients, while the decrease in heart failure hospitalizations was particularly marked in those aged ≥80 years. These findings support an early intervention strategy regardless of patient age.
Original Title: Age and Procedural Timing for Asymptomatic Severe Aortic Stenosis: Analysis From the EARLY TAVR Trial.
