Aortic Valve Replacement vs Clinical Surveillance in Asymptomatic Severe Aortic Stenosis

Current guidelines recommend a strategy of clinical surveillance (CS) for patients with asymptomatic severe aortic stenosis (AS) and a normal left ventricular ejection fraction. The aim of this study was to conduct a study-level meta-analysis of randomized controlled trials (RCTs) evaluating the effect of early aortic valve replacement (AVR) compared with CS in patients with asymptomatic severe AS. Studies were quantitatively assessed in a meta-analysis using random-effects modeling. Prespecified outcomes included all-cause and cardiovascular mortality, unplanned cardiovascular or heart failure (HF) hospitalization, and stroke. The meta-analysis is registered at the International Platform of Registered Systematic Review and Meta-Analysis Protocols (INPLASY202490002). Four RCTs were identified, including a total of 1,427 patients (719 in the early AVR group and 708 in the CS group). At an average follow-up time of 4.1 years, early AVR was associated with a significant reduction in unplanned cardiovascular or HF hospitalization (pooled rate 14.6% vs 31.9%; HR: 0.40; 95% CI: 0.30-0.53; I2 = 4%; P < 0.01) and stroke (pooled rate 4.5% vs 7.2%; HR: 0.62; 95% CI: 0.40-0.97; I2 = 0%; P = 0.03). No differences in all-cause mortality (pooled rate 9.7% vs 13.7%; HR: 0.68; 95% CI: 0.40-1.17; I2 = 61%; P = 0.17) and cardiovascular mortality (pooled rate 5.1% vs 8.3%; HR: 0.67; 95% CI: 0.35-1.29; I2 = 50%; P = 0.23) were observed with early AVR compared with CS, although there was a high degree of heterogeneity among studies. In this meta-analysis of 4 RCTs, early AVR was associated with a significant reduction in unplanned cardiovascular or HF hospitalization and stroke and no differences in all-cause and cardiovascular mortality compared with CS.