Practical TakeawaysThe absence of a statistically significant mortality benefit does not rule out a mortality benefit for TAVR. Given the small sample si ze (80 TAVR, 40 OMT) and wide confidence intervals, substantial uncertainty remains regarding mortality estimates.
summary
A total of 120 patients were randomized 2:1 to receive immediate TAVR plus optimal medical therapy (n=80) or initial conservative treatment (n=40). In the conservative group, 47.5% eventually required rescue TAVR. Immediate TAVR was not associated with a statistically significant reduction in all-cause mortality. The primary endpoint, defined as all-cause death two years after last patient inclusion, was as follows: TAVR:29.0%. OMT:37.1%, HR 0.83 (95% CI 0.41–1.66), P = 0.60. Mortality was numerically lower in the TAVR group but not statistically significant