Statistical analysis
death
ADVERSE EVENTS, SECONDARY, ADVERSE EVENT
For the statistical analysis of primary and secondary endpoints, the mean value of change before and after the LIPUS therapy and the confidence interval were estimated, and comparisons were made between the 2 groups using the t-test. The Wald method was used for the comparison of the proportion of improved cases after the treatment and the estimation of the confidence interval. MACE and all-cause death were compared as cumulative incidence using Gray’s test where dropout due to death from non-cardiovascular causes or non-MACE adverse events were treated as a competing risk. For the estimation of the hazard ratio and P-value, the Fine and Gray model, which is an extension hazard model of the Cox’s proportional hazards model, was used. Point estimates and 95% confidence intervals for adverse event withdrawal rates were calculated for each group at 450 days after the initial treatment. P value less than 0.05 was considered to be statistically significant.