Heart Care Foundation ANMCO Research Centre, Florence, Italy.
Hull University Teaching Hospitals NHS Trust, Hull, UK.
ESC Heart Fail. 2022 Dec;9(6):4209-4218. doi: 10.1002/ehf2.14014. Epub 2022 Sep 15.
ARIADNE aimed to assess the association between effects of sacubitril/valsartan and no sacubitril/valsartan treatment and clinical characteristics, functional capacity, and clinical outcomes (cause-specific mortality and hospitalizations) in outpatients with heart failure (HF) with reduced ejection fraction (HFrEF).
ARIADNE was a prospective European registry of 9069 patients with HFrEF treated by office-based cardiologists or selected primary care physicians. Of the 8787 eligible for analysis, 4173 patients were on conventional HF treatment (non-S/V group), whereas 4614 patients were either on sacubitril/valsartan treatment at enrolment or started sacubitril/valsartan within 1 month of enrolment (S/V group). We also generated a restricted analysis set (rS/V) including only those 2108 patients who started sacubitril/valsartan treatment within the month prior to or after enrolment.
At the baseline, average age of patients enrolled in the study was 68 years, and 23.9% (2099/8787) were female. At the baseline, the proportions of patients with New York Heart Association (NYHA) Class III symptoms were 30.9 (1288/4173), 42.8 (1974/4614), and 48.2% (1015/2108), in non-S/V, S/V, and rS/V groups, respectively. After 12 months of treatment, the proportion of patients with NYHA Class III at baseline who improved to Class II was 32.0% (290/907) in the non-S/V group vs. 46.3% (648/1399) in S/V group and 48.7% (349/717) in rS/V group. The overall mortality rate was 5.0 per 100 patient-years. Rates of HF hospitalizations were high (20.9, 20.3, and 21.2 per 100 patient-years in the non-S/V, S/V, and rS/V groups, respectively). Emergency room visits without hospitalization occurred in 3.9, 3.2, and 3.9% of patients in the non-S/V, S/V, and rS/V groups, respectively.
This large HFrEF European registry provides a contemporary outcome profile of outpatients with HFrEF treated with or without sacubitril/valsartan. In a real-world setting, sacubitril/valsartan was associated with an improvement of symptoms in patients with HFrEF compared with the conventional HFrEF treatment.
ARIADNE 旨在评估沙库巴曲缬沙坦的疗效与临床特征、功能能力和临床结局（特定原因死亡率和住院率）之间的关联，这些结局在射血分数降低的心力衰竭（HFrEF）门诊患者中，与是否使用沙库巴曲缬沙坦治疗有关。
ARIADNE 是一项针对欧洲 9069 例 HFrEF 患者的前瞻性注册研究，这些患者由门诊心脏病专家或选定的初级保健医生治疗。在 8787 例符合分析条件的患者中，4173 例接受常规 HF 治疗（非 S/V 组），而 4614 例患者在入组时接受沙库巴曲缬沙坦治疗或在入组后 1 个月内开始沙库巴曲缬沙坦治疗（S/V 组）。我们还生成了一个受限分析集（rS/V），仅包括在入组前或入组后 1 个月内开始沙库巴曲缬沙坦治疗的 2108 例患者。
在研究的基线时，纳入研究的患者平均年龄为 68 岁，23.9%（2099/8787）为女性。在基线时，纽约心脏协会（NYHA）心功能 III 级症状的患者比例分别为 30.9%（1288/4173）、42.8%（1974/4614）和 48.2%（1015/2108），分别在非 S/V、S/V 和 rS/V 组中。在治疗 12 个月后，基线时 NYHA 心功能 III 级的患者中，改善为 II 级的比例分别为非 S/V 组 32.0%（290/907）、S/V 组 46.3%（648/1399）和 rS/V 组 48.7%（349/717）。总的死亡率为每 100 患者-年 5.0 例。心力衰竭住院率较高（非 S/V、S/V 和 rS/V 组分别为每 100 患者-年 20.9、20.3 和 21.2 例）。急诊就诊但未住院的患者分别占非 S/V、S/V 和 rS/V 组患者的 3.9%、3.2%和 3.9%。
这项大型欧洲 HFrEF 注册研究提供了射血分数降低的心力衰竭门诊患者使用或不使用沙库巴曲缬沙坦治疗的当代结局概况。在真实世界环境中，与常规 HFrEF 治疗相比，沙库巴曲缬沙坦可改善 HFrEF 患者的症状。
