P779Eligible patients for the PARADIGM-HF trial in a real-world outpatient clinic and its cardiovascular risk

Abstract

Abstract Background In the PARADIGM-HF trial sacubitril-valsartan, an angiotensin receptor-neprilysin inhibitor (ARNI), was more effective than enalapril for some patients with heart failure (HF). However, the eligibility of the PARADIGM-HF study to a real-world heart failure population was not well established. Purpose To investigate the eligibility of PARADIGM-HF Trial in a real-world clinical setting and its cardiovascular risk. Methods We made secondary analysis of patients (n=4872) with heart failure prospectively enrolled in the Swedish Heart Failure Registry from the Outpatient Clinic, during 2005–2016. The eligibility for PARADIGM-HF in real world was studied based on patients whether they were either fully or partially compatible with the PARADIGM-HF study population. Mortality data during follow-up were obtained from the Death Registry of the National Board of Health and Welfare in Sweden. Results Heart failure with reduced LVEF (≤40%) (HFrEF) were found in 2165 patients, 653 patients (30%) were fully and 958 (44%) were partially compatible with PARADIGM-HF criteria respectively (figure). In both the fully and partially eligible groups there were more male. Despite that the fully eligible patients were younger than non-eligible patients (77.6±12.7 vs. 84.0±13.7 years), they were clearly older than in PARADIGM-HF trial. Moreover, those fully-eligible patients had lower all-cause mortality compared with both partially-and non-eligible patients (45.6% vs. 68.5, HR 1.43 (1.18–1.75) p<0.001) after adjusted for sex, age, BMI, smoking, hypertension and diabetes. However, both fully- and partially eligible patients had higher all-cause mortality than that in PARADIGM-HF. figure Conclusion In a real world outpatient clinical setting, around 35% to 50% of HFrEF were eligible for treatment with ARNI except that they are older, sicker and carried higher risk for all-cause mortality than the PARADIGM-HF trial population.