Statistical analyses
REGRESSION, EVENTS, SECONDARY, EVENT
Descriptive statistics will be used to report baseline characteristics of the study population. The primary and secondary endpoints can occur during the entire participation period, which is from baseline to ablation (in the intervention group during the risk treatment; in the control group when patients await the ablation) and in 12 months after the ablation. The different pre-ablation durations amongst patients lead to different study participation periods. Therefore, the number of events will be normalized using the participation period and will be reported in numbers per year (the event rate). The clinical hypothesis that the intervention group will have a lower event rate will be tested by fitting a Poisson regression model to the event data and testing the effect of the intervention group using a Wald test. Results will be reported in terms of incidence risk ratios with accompanying 95% confidence intervals. The primary analysis will be on an intention-to-treat basis. Subgroup analyses will be performed on the primary endpoint. Covariates of interest in this study include gender, age, type of AF (paroxysmal vs. persistent) and number and extent of the respective modifiable risk factors as defined in Table The secondary endpoints will be analysed by means of chi-squared test or Fisher’s exact test depending on the number of occurrences. Changes in weight and blood pressure will be compared using the appropriate test (unpaired A cost-effectiveness analysis will be included, covering incremental cost-effectiveness ratio (ICER) and an evaluation of change in patient value, using the EuroQol-5D and AFEQT questionnaires and healthcare-related costs of intervention. Differences in medical hospital costs for both study groups will be compared using the appropriate statistical test (unpaired A 