CHAPTER 2.1 26 Figure 2. Cumulative incidence curves for first HF hospitalization at 1 year by (i) RCT participants, (ii)RCT-eligible and (iii) RCT-non-eligible registry patients DISCUSSION The present study has individual patient data of over 62 000 patients from five clinical trials and two observational HF registries, which allowed direct and adjusted comparisons on patient characteristics for both all-cause and cause-specific mortality. Overall, we found that over half of patients in the registries met the most commonly used in- and ex-clusion criteria for trial enrolment. Unadjusted survival was markedly lower in registries than trials. However, after adjusting for case-mix, all-cause mortality rates were comparable between the trials and registries while cardiovascular mortality occurred more frequently in the trial participants compared to registry patients. We identified a higher proportion of trial-eligible patients compared to previous studies on patients with acute decompensated HF and HF with reduced and preserved ejection fraction: 56% vs. 13 % to 42%.8,28,29 Furthermore, the percentage of trial-eligible registry patients who were given at least 50% target doses of HF medications were slightly higher than in RCTs. This higher proportion compared to previous reports could be explained at least in part by extensive heart failure programs and nurse-led up-titration of disease-modifying therapies in the Number at risk Registry (RCT-non-eligible) 17382 12802 11320 10242 9334 Registry (RCT-eligible) 22848 18911 17179 15766 14583 RCT 16922 16387 15895 15151 14459
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