What is the primary outcome of the FREEDOM Trial?
The primary outcome of the FREEDOM Trial was the rate of death from any cause, MI, or stroke, and the p value was calculated with the log-rank test on the basis of all available follow-up data (ie, >5 y). The p-value was 0.006 in the as-treated (non-intention-to-treat) analysis and 0.16 by the WaLd test of the Cox regression estimate for study-group assignment in 1712 patients after adjustment for average glucose level after procedure.