Statistical analyses
TIA, stroke, bleeding, death
BLEEDING, STROKE, MINOR, EVENT, STROKE SYNDROME, REGRESSION, TIA
Data are number (%), median [interquartile range] or mean (standard deviation).The effect of treatment on the primary safety outcome was analysed as a shift in bleeding and its severity (fatal, major, moderate, minor and none) using ordinal logistic regression. Additional sensitivity analyses included assessing bleeding individually by level of severity and as all bleeding. Comparisons between bleeding severity levels and treatments were assessed using ANOVA, the Chi-Square/Fisher's Exact test, the Kruskal-Wallis test, Kendall's rank correlation and Jonckheere-Terpstra test. Further analyses were performed using binary logistic regression (reported as adjusted odds ratio, aOR), ordinal logistic regression (adjusted common odds ratio, aOR) or multiple linear regression (adjusted mean difference, aMD); 95% confidence intervals are given with each, and covariates comprised: index event (TIA vs stroke), country, guideline randomisation choice, age, sex, pre-morbid function, systolic blood pressure, stroke syndrome (cortical vs. lacunarTo assess the treatment effect on ordinal bleeding in pre-specified subgroups, an interaction term was added to an adjusted ordinal logistic regression model. Clinical outcomes included a value for death, as is standard for the mRS, Barthel Index and EQ-5D; values comprised: mRS 6, Barthel Index -5, t-MMSE -1, TICS-M -1, Verbal fluency -1, EQ-5D3L-HSUV 0, EQ-VAS -1, Zung 102.5. Age was analysed using a pre-specified cut-point (≤ 75 vs > 75 years) as well as a continuous variable using multiple linear regression.We compared performance of the REACH, S