Proefschrift

Generalizability of HFrEF trials 19 SMRs from each subset were then compared to the original estimates. A third sensitivity analysis was performed to determine the effects of time period differences between trial and registry data on HF medication prescription. RESULTS Study population Majority of registry patients (56%) were eligible for inclusion in the trials (Figure 1). Compared to the overall registry group, RCT patients were younger (mean 63.6 years vs 72.7 years), less frequently women (22% vs 31%), had longer duration of HF, were more often in LVEF category of 30-39% as opposed to <30% and predominantly in NYHA class II rather than III- IV (Table 1). The baseline characteristics of each registry is provided in Supplementary Table 3. Hypertension, diabetes, and CAD were more common in the RCT group compared to the overall registry group. However, the proportion of patients with valve disease, stroke, anaemia, COPD, cancer, and coronary revascularisation were markedly lower in the RCT patients. After restricting the registry group to those who would be eligible for inclusion in the RCTs, this RCT-eligible registry group was more similar to the RCT group in NYHA class, serum creatinine, and haemoglobin, but differences in comorbidities largely remained (Table 1). In the selection of trialeligible patients, the most restrictive inclusion criteria were NYHA class II-IV and the use of ACEI/ARB and ß-blockers while the most restrictive exclusion criterion was cancer (Figure 1). Use and target doses of cardiovascular medication Prescription of medications was higher for antiplatelets, mineralocorticoid receptor antagonists, and statins in the RCTs compared to registry patients. Despite similar proportions in use of ACEI/ ARB (87% vs 90%), more registry than RCT patients received higher doses (≥ 50% of target doses) of these medications (Supplementary table 4). We then restricted the comparison to the same time periods (2005 - 2009) between the 2 largest trials and SwedeHF registry patients and found that the proportion of patients who were given target doses did not differ much from the main findings, which used data from 2001 to 2016 (Supplementary Table 5). 2.1

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