Department of Pharmacology and Clinical Neuroscience, Umeå University, S-901 87, Umeå, Sweden.
Department of Public Health and Clinical Medicine, Umeå University, S-901 87, Umeå, Sweden.
ESC Heart Fail. 2018 Apr;5(2):337-343. doi: 10.1002/ehf2.12251. Epub 2018 Jan 18.
This study aims to investigate the eligibility of the Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor (ARNI) with ACE inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) study to a real-world heart failure population.
Medical records of all heart failure patients living within the catchment area of Umeå University Hospital were reviewed. This district consists of around 150 000 people. Out of 2029 patients with a diagnosis of heart failure, 1924 (95%) had at least one echocardiography performed, and 401 patients had an ejection fraction of ≤35% at their latest examination. The major PARADIGM-HF criteria were applied, and 95 patients fulfilled all enrolment criteria and thus were eligible for sacubitril-valsartan. This corresponds to 5% of the overall heart failure population and 24% of the population with ejection fraction ≤ 35%. The eligible patients were significantly older (73.2 ± 10.3 vs. 63.8 ± 11.5 years), had higher blood pressure (128 ± 17 vs. 122 ± 15 mmHg), had higher heart rate (77 ± 17 vs. 72 ± 12 b.p.m.), and had more atrial fibrillation (51.6% vs. 36.2%) than did the PARADIGM-HF population.
Only 24% of our real-world heart failure and reduced ejection fraction population was eligible for sacubitril-valsartan, and the real-world heart failure and reduced ejection fraction patients were significantly older than the PARADIGM-HF population. The lack of data on a majority of the patients that we see in clinical practice is a real problem, and we are limited to extrapolation of results on a slightly different population. This is difficult to address, but perhaps registry-based randomized clinical trials will help to solve this issue.
本研究旨在探讨 Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor (ARNI) with ACE inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) 研究纳入真实世界心力衰竭人群的适宜性。
对居住在于默奥大学医院（Umeå University Hospital）服务区内的所有心力衰竭患者的病历进行了回顾。该地区约有 15 万人。在 2029 名心力衰竭诊断患者中，有 1924 名（95%）至少进行了一次超声心动图检查，401 名患者在最近一次检查时射血分数≤35%。应用主要的 PARADIGM-HF 标准，有 95 名患者符合所有入组标准，因此有资格接受沙库巴曲缬沙坦。这相当于整体心力衰竭人群的 5%和射血分数≤35%人群的 24%。符合条件的患者明显更年长（73.2±10.3 岁比 63.8±11.5 岁），血压更高（128±17 毫米汞柱比 122±15 毫米汞柱），心率更快（77±17 次/分比 72±12 次/分），心房颤动更多（51.6%比 36.2%）。
在我们的真实世界心力衰竭和射血分数降低的人群中，只有 24%符合沙库巴曲缬沙坦的条件，而真实世界心力衰竭和射血分数降低的患者明显比 PARADIGM-HF 人群更年长。我们在临床实践中看到的大多数患者的数据缺乏，这是一个真正的问题，我们只能对略有不同的人群进行结果外推。这很难解决，但也许基于登记的随机临床试验将有助于解决这个问题。
