Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis—EARLY TAVR Trial

The EARLY TAVR trial investigators randomly assigned patients with asymptomatic severe aortic stenosis to undergo either early transfemoral transcatheter aortic valve replacement (TAVR) or clinical surveillance. The primary end point was a composite of death, stroke, or unplanned hospitalization for cardiovascular causes. Superiority testing was conducted in the intention-to-treat population. A total of 901 patients underwent randomization—455 patients were assigned to the TAVR group, and 446 patients were assigned to the clinical surveillance group. The mean age of the patients was 75.8 years, the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.8 percent, and 83.6 percent of patients were classified as low surgical risk. A primary end point event occurred in 122 patients (26.8 percent) in the TAVR group and 202 patients (45.3 percent) in the clinical surveillance group (hazard ratio, 0.50; 95 percent confidence interval, 0.40 to 0.63; P<0.001). In the TAVR and clinical surveillance groups, death occurred in 8.4 percent and 9.2 percent, respectively; stroke occurred in 4.2 percent and 6.7 percent, respectively; and unplanned hospitalization for cardiovascular causes occurred in 20.9 percent and 41.7 percent, respectively. During a median follow-up of 3.8 years, 87.0 percent of patients in the clinical surveillance group underwent aortic-valve replacement. Conversion to TAVR from the clinical surveillance group was 47.2 percent at 12 months.