Statistical analysis
primary disease, stroke
MYOCARDIAL INFARCTION, MYOCARDIAL INFARCTION, STROKE, STROKE, REGRESSION, EVENTS, CARDIAC DECOMPENSATION
The amended SAP was previously published [Analysis populations for the primary endpoints were the full analysis set (FAS) based on the intention-to-treat (ITT) principle. The full analysis set (FAS) consisted of all randomized patients with informed consent who began their assigned care. Baseline characteristics were summarized as number of patients, with percentages in parenthesis, for categorical variables and as mean, with standard deviation in parenthesis, for continuous variables.The following hierarchical test procedure was planned. First, the primary endpoint concerning the number of days spent in hospital (hypothesis 2) was to be tested. If this analysis was significant at a two-sided 5% test-level, the full significance level was to fall to the first combined endpoint consisting of myocardial infarction, stroke, or mortality. If no statistical difference was found in the length of hospitalization, then none of the predefined outcome measures were considered significant and superiority of NICC over SoC was not shown. If these two primary endpoints were significant, the full significance was to fall to the last primary endpoint, meaning the combined endpoint of mortality, stroke, myocardial infarction, and cardiac decompensation (hypotheses 3).Regression analyses were conducted after adjusting for primary disease (AF, HF, and TRH) and centre. The category with the largest numbers was employed as a reference category. Tests were based on the two-sided asymptotic Wald test, with the corresponding 95% confidence intervals (95%CI). Quasi-Poisson regression was applied for count data, logistic regression for the composite endpoints, along with mortality and major adverse cardiovascular events (MACE), defined as myocardial infarction, stroke or cardiovascular mortality. Rate ratios (RR) or odds ratios (OR) were estimated. Secondary analysis included survival analysis for the combined endpoints, mortality, and MACE, where Cox regression was used after adjusting for stratification variables. Kaplan–Meier curves were estimated, and the exact log rank test was calculated.Based on the amended SAP, core variables for multiple imputations were sex, age, primary disease, centre, and EQ-5D-5L index at baseline. Hospitalization endpoints relied on health insurance data. These data were complete, excepting 38 patients (NICC: 