CHAPTER 2.1 20 Clinical outcomes at one year Cumulative incidence curves are shown in the central illustration and Figure 2. Allcause mortality, cardiovascular mortality and first HF hospitalization at one year were lower in the RCTs than in trial-eligible and trial non-eligible registry groups. There was no remaining difference in all-cause mortality risk between trial and registry patients after adjusting for known HF prognostic factors (fully-adjusted (model 4) SMR 1.04; 95%CI 0.98 – 1.11)) (Central Illustration). However, higher cardiovascular mortality risk persisted in the RCT group compared to trial-eligible registry patients (fully-adjusted (model 4) SMR 1.28; 95%CI 1.20 – 1.37). Age and sex explained most of the mortality difference between patient groups, as reflected in the large shift of SMR between Model 1 (empty model) to Model 2 (with age and sex). Stepwise addition of prognostic factors changed SMR in the same direction but to a lesser degree, as seen in the shift of SMR in Model 2 (with age and sex) to Model 4 (fully adjusted) for all-cause and cardiovascular mortality. Sensitivity analyses were conducted by estimating SMRs in a subset of patients who were in sinus rhythm and estimates were similar to those obtained in the main results (Supplementary figures 1 and 2).
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