Department of Cardiology, Castle Hill Hospital, Hull York Medical School (at University of Hull), Kingston upon Hull, UK.
National Heart & Lung Institute and National Institute of Health Research Cardiovascular Biomedical Research Unit, Royal Brompton & Harefield Hospitals, Imperial College, London, UK.
Eur J Heart Fail. 2017 Jun;19(6):768-778. doi: 10.1002/ejhf.788. Epub 2017 Feb 27.
The PARADIGM-HF trial showed that sacubitril-valsartan, an ARB-neprilysin inhibitor, is more effective than enalapril for some patients with heart failure (HF). It is uncertain what proportion of patients with HF would be eligible for sacubitril-valsartan in clinical practice.
Between 2001 and 2014, 6131 patients consecutively referred to a community HF clinic with suspected HF were assessed. The criteria required to enter the randomized phase of PARADIGM-HF, including symptoms, NT-proBNP, and current treatment with or without target doses of ACE inhibitors or ARBs, were applied to identify the proportion of patients eligible for sacubitril-valsartan. Recognizing the diversity of clinical opinion and guideline recommendations concerning this issue, entry criteria were applied singly and in combination. Of 1396 patients with reduced left ventricular ejection fraction (≤40%, HFrEF) and contemporary measurement of NT-proBNP, 379 were on target doses of an ACE inhibitor or ARB at their initial visit and, of these, 172 (45%) fulfilled the key entry criteria for the PARADIGM-HF trial. Lack of symptoms (32%) and NT-proBNP <600 ng/L (49%) were common reasons for failure to fulfil criteria. A further 122 patients became eligible during follow-up (n = 294, 21%). However, if background medication and doses were ignored, then 701 (50%) were eligible initially and a further 137 became eligible during follow-up.
Of patients with HFrEF referred to a clinic such as ours, only 21% fulfilled the PARADIGM-HF randomization criteria, on which the ESC Guidelines are based; this proportion rises to 60% if background medication is ignored.
PARADIGM-HF 试验表明，沙库巴曲缬沙坦（一种 ARB-脑啡肽酶抑制剂）在某些心力衰竭（HF）患者中的疗效优于依那普利。目前尚不确定在临床实践中，有多少 HF 患者有资格接受沙库巴曲缬沙坦治疗。
2001 年至 2014 年，连续有 6131 例疑似 HF 的患者被转诊至社区 HF 诊所进行评估。应用 PARADIGM-HF 随机阶段的纳入标准（包括症状、NT-proBNP 和当前治疗方案，是否使用或未使用目标剂量的 ACE 抑制剂或 ARB），以确定有资格接受沙库巴曲缬沙坦治疗的患者比例。鉴于对此问题的临床意见和指南推荐存在多样性，我们单独和联合应用了纳入标准。在 1396 例左心室射血分数降低（≤40%，HFrEF）且 NT-proBNP 为近期测量值的患者中，有 379 例在初诊时正在使用 ACE 抑制剂或 ARB 的目标剂量，其中 172 例（45%）符合 PARADIGM-HF 试验的主要纳入标准。不符合纳入标准的常见原因是缺乏症状（32%）和 NT-proBNP<600ng/L（49%）。另有 122 例患者在随访期间符合纳入标准（n=294，21%）。然而，如果忽略背景药物和剂量，则最初有 701 例（50%）符合纳入标准，在随访期间另有 137 例符合纳入标准。
在像我们这样的诊所就诊的 HFrEF 患者中，仅有 21%符合 ESC 指南所依据的 PARADIGM-HF 随机分组标准；如果忽略背景药物，则该比例上升至 60%。
