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.

中文翻译：

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ESC-EORP-HFA心力衰竭长期注册中的沙奎特利/缬沙坦合格率和结果：欧洲药品管理局/食品和药物管理局标签，PARADIGM-HF试验，ESC指南和现实世界之间的桥梁。

目的根据PARADIGM-HF试验，根据欧洲药品管理局/食品药品管理局（EMA / FDA）的标签，评估有资格接受沙必特/缬沙坦（LCZ696）的心力衰竭和射血分数降低的患者的比例以及2016年的ESC指南，以及资格与结果之间的关联。方法和结果考虑了2011年3月至2013年11月在ESC-EORP-HFA长期心力衰竭（HF-LT）登记中患有HFrEF的门诊患者。应用了基于EMA / FDA标签，PARADIGM-HF和ESC准则的LCZ696标准。在5443位患者中，有2197位和2373位具有完整的试验和指南资格评估信息，分别达到EMA / FDA标签，PARADIGM-HF和指南标准的患者分别为84％，12％和12％。缺乏PARADIGM-HF标准是低钠尿肽（21％），高钾血症（4％），低血压（7％）和次优药物疗法（74％）；缺乏指导原则的标准是LVEF> 35％（23％），NP水平不足（30％）和次优药物治疗（82％）；没有标签标准是没有症状（纽约心脏协会I类）。当每天使用ACEi / ARB≥10 mg依那普利（而不是≥20 mg）时，根据PARADIGM-HF和指南，合格率从12％上升至28％。与PARADIGM-HF的依那普利组相比，符合注册条件的患者一年心衰住院率更高（12％和17％比12％），全因死亡率更低（5.3％和6.5％vs. 7.7％）。结论在ESC-EORP-HFA HF-LT注册中心的HFrEF门诊患者中，有84％符合标签标准，如果分别需要≥20 mg和≥10 mg依那普利，则分别只有12％和28％符合PARADIGM-HF和LCZ696准则要求。与PARADIGM-HF依那普利组相比，符合LCZ696资格的登记患者住院率更高，但死亡率更低。