Duke Clinical Research Institute, Durham, NC
Department of Medicine, Duke University School of Medicine, Durham, NC.
J Am Heart Assoc. 2018 Jun 12;7(12):e009237. doi: 10.1161/JAHA.118.009237.
The US Food and Drug Administration approved sacubitril/valsartan for patients with chronic heart failure (HF) with reduced ejection fraction in 2015 on the basis of the results of the PARADIGM-HF (Prospective Comparison of ARNI [Angiotensin Receptor Neprilysin Inhibitor] With ACEI [Angiotensin-Converting Enzyme Inhibitor] to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial. There are limited data assessing the generalizability of PARADIGM-HF trial participants to a broader population of patients with HF with reduced ejection fraction routinely encountered in outpatient clinical practice.
We compared the baseline characteristics of patients in the PARADIGM-HF trial with those in the CHAMP-HF (Change the Management of Patients With Heart Failure) study a large US outpatient registry of patients with HF with reduced ejection fraction. Patients in the PARADIGM-HF trial (n=8442) were similar to those in the CHAMP-HF registry (n=3497) in terms of age (mean, 64 versus 66 years), sex (22% versus 29% women), New York Heart Association class III to IV (25% versus 32%), systolic blood pressure (mean, 121 versus 121 mm Hg), left ventricular ejection fraction (mean, 29% versus 29%), and other key baseline characteristics. The median (25th-75 percentile) Meta-Analysis Global Group in Chronic Heart Failure risk scores were similar for the 2 studies (20 [16-24] versus 22 [8-27]). Despite this, only 13% of patients in the CHAMP-HF registry were prescribed sacubitril/valsartan at baseline.
These data suggest participants randomized in the PARADIGM-HF trial have similar baseline characteristics to those encountered in routine outpatient clinical practice, but there is a substantial lag in the adoption of sacubitril/valsartan for patients with chronic HF with reduced ejection fraction.
美国食品和药物管理局于 2015 年基于 PARADIGM-HF（沙库巴曲缬沙坦与血管紧张素转换酶抑制剂治疗射血分数降低的心力衰竭患者的前瞻性比较试验）的研究结果批准了沙库巴曲缬沙坦用于射血分数降低的慢性心力衰竭（HF）患者。目前，评估 PARADIGM-HF 试验参与者是否可推广至在门诊临床实践中更为常见的射血分数降低的 HF 患者人群的相关数据十分有限。
我们将 PARADIGM-HF 试验患者的基线特征与 CHAMP-HF（心力衰竭患者管理的改变）研究（一项大型美国射血分数降低的 HF 门诊患者注册研究）进行了比较。PARADIGM-HF 试验（n=8442）患者与 CHAMP-HF 登记患者（n=3497）在年龄（平均 64 岁比 66 岁）、性别（22%比 29%为女性）、纽约心脏协会心功能分级 III 至 IV 级（25%比 32%）、收缩压（平均 121mmHg 比 121mmHg）、左心室射血分数（平均 29%比 29%）和其他关键基线特征方面相似。这两项研究的中位数（25 分位数至 75 分位数）Meta 分析全球慢性心力衰竭风险评分相似（20[16-24]比 22[8-27]）。尽管如此，CHAMP-HF 登记患者中仅有 13%在基线时处方了沙库巴曲缬沙坦。
这些数据表明，PARADIGM-HF 试验中随机分组的患者具有与常规门诊临床实践中相似的基线特征，但在为射血分数降低的慢性 HF 患者应用沙库巴曲缬沙坦方面存在明显滞后。
