Aims
To assess the proportion of patients with heart failure and reduced ejection fraction (HFrEF) who are eligible for sacubitril/valsartan (LCZ696) based on the European Medicines Agency/Food and Drug Administration (EMA/FDA) label, the PARADIGM‐HF trial and the 2016 ESC guidelines, and the association between eligibility and outcomes.
Methods and results
Outpatients with HFrEF in the ESC‐EORP‐HFA Long‐Term Heart Failure (HF‐LT) Registry between March 2011 and November 2013 were considered. Criteria for LCZ696 based on EMA/FDA label, PARADIGM‐HF and ESC guidelines were applied. Of 5443 patients, 2197 and 2373 had complete information for trial and guideline eligibility assessment, and 84%, 12% and 12% met EMA/FDA label, PARADIGM‐HF and guideline criteria, respectively. Absent PARADIGM‐HF criteria were low natriuretic peptides (21%), hyperkalemia (4%), hypotension (7%) and sub‐optimal pharmacotherapy (74%); absent Guidelines criteria were LVEF>35% (23%), insufficient NP levels (30%)
and sub‐optimal pharmacotherapy (82%); absent label criteria were absence of symptoms (New York Heart Association class I). When a daily requirement of ACEi/ARB ≥ 10 mg enalapril (instead of ≥ 20 mg) was used, eligibility rose from 12% to 28% based on both PARADIGM‐HF and guidelines. One‐year heart failure hospitalization was higher (12% and 17% vs. 12%) and all‐cause mortality lower (5.3% and 6.5% vs. 7.7%) in registry eligible patients compared to the enalapril arm of PARADIGM‐HF.
Conclusions
Among outpatients with HFrEF in the ESC‐EORP‐HFA HF‐LT Registry, 84% met label criteria, while only 12% and 28% met PARADIGM‐HF and guideline criteria for LCZ696 if requiring ≥ 20 mg and ≥ 10 mg enalapril, respectively. Registry patients eligible for LCZ696 had greater heart failure hospitalization but lower mortality rates than the PARADIGM‐HF enalapril group.
Obstructive sleep apnea (OSA) has been described as an independent predictor of mortality and cardiovascular morbidity, and several studies link OAS and atrial fibrillation, although further investigations are needed to fully understand the common physiological mechanisms. The aim of the study was to identify the cardiovascular risk and events of a population diagnosed with OAS and to discover the predisposing factors of the appearance of AF in these patients. Demographic, clinical, laboratory and echocardiographic data were taken from 101 patients previously diagnosed with OSA and admitted to our cardiovascular unit. In a population with cardiovascular risk factors and cerebrovascular events, the prevalence of atrial fibrillation was 63.7%, whereas ventricular arrythmias occurred in 31.4%. The only prediction factor for AF in OSA population was the history of myocardial infarction; other predisposing factors take account for a small number of cases. The presence of a significant association between OSA and markers of cardiovascular disease would warrant the development of a strategy to consider more aggressive therapeutic approaches.
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