Early Intervention in Patients With Asymptomatic Severe Aortic Stenosis and Myocardial Fibrosis: The EVOLVED trial

Development of myocardial fibrosis in patients with aortic stenosis precedes left ventricular decompensation and is associated with an adverse long-term prognosis. This study aimed to investigate whether early valve intervention reduces the incidence of all-cause death or unplanned aortic stenosis-related hospitalization in asymptomatic patients with severe aortic stenosis and myocardial fibrosis. In this trial, asymptomatic patients with severe aortic stenosis and myocardial fibrosis were randomized to undergo early valve intervention with either transcatheter or surgical aortic valve replacement or guideline-directed conservative management. The primary outcome was a composite of all-cause death or unplanned aortic stenosis-related hospitalization in a time-to-first-event intention-to-treat analysis. The trial enrolled 224 eligible patients (mean age, 73 years; 63 women [28 percent]), a subset of the originally planned 356 patients. Surgical aortic valve replacement was performed in 80 patients (75 percent), and transcatheter aortic valve intervention in 26 patients (25 percent). The primary end point occurred in 20 of 113 patients (18 percent) in the early intervention group and 25 of 111 patients (23 percent) in the guideline-directed conservative management group (hazard ratio, 0.79 [95 percent CI, 0.44-1.43]; P = 0.44; between-group difference, -4.82 percent [95 percent CI, -15.31 percent to 5.66 percent]). All-cause death occurred in 16 of 113 patients (14 percent) in the early intervention group and 14 of 111 (13 percent) in the guideline-directed group (hazard ratio, 1.22 [95 percent CI, 0.59-2.51]). Unplanned aortic stenosis-related hospitalization occurred in 7 of 113 patients (6 percent) in the early intervention group and 19 of 111 patients (17 percent) in the guideline-directed group, respectively (hazard ratio, 0.37 [95 percent CI, 0.16-0.88]). The authors concluded that in asymptomatic patients with severe aortic stenosis and myocardial fibrosis, early aortic valve intervention had no demonstrable effect on all-cause death or unplanned aortic stenosis-related hospitalization.