Statistical analysis
coronary artery disease
REGRESSION, EVENTS, CORONARY ARTERY DISEASE
The analysis will be based on the intention-to-treat principle and will include all outcomes occurring from randomisation to a common study end date. Follow-up will continue until 97 primary outcome events have been accrued in the standard of care arm. Primary endpoint survival times will be depicted using the Kaplan–Meier survival curves and formally assessed using a Cox proportional hazards model which will adjust for study site, age, sex and previous coronary artery disease (the variables on which the randomisation was stratified). The results will be expressed as a hazard ratio with the corresponding 95% confidence intervals and Secondary outcomes will be analysed using appropriate methods—logistic regression for binary outcomes and linear regression for normally distributed continuous outcomes. Continuous outcomes that are not normally distributed will be analysed using appropriate nonparametric techniques. Subgroup analysis on the primary outcome is planned for participants: (i) sex, (ii) age, (iii) with and without a previous diagnosis of coronary artery disease at randomisation, (iv) with and without preventative therapy (statin and anti-platelet agent) at randomisation, (v) above and below the sex and assay-specific median maximum high sensitivity cardiac troponin concentration at presentation. These will be assessed by examining the effect of the intervention by subgroup interaction in the Cox regression model.The influence of any missing data on the robustness of the findings will be examined using multiple imputation models under a missing at random assumption. All statistical analyses will be pre-specified in a comprehensive statistical analysis plan, authored by the study statisticians and agreed by the independent study oversight committees.