Galván Ruiz Mario, Fernández de Sanmamed Girón Miguel, Del Val Groba Marco María, Rojo Jorge Lorena, Peña Saavedra Claudia, Martín Bou Elvira, Andrade Guerra Rubén, Caballero Dorta Eduardo, García Quintana Antonio
Department of Cardiology, Hospital Universitario de Gran Canaria Doctor Negrín, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.
Department of Cardiology, Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria, Spain.
ESC Heart Fail. 2024 Dec;11(6):4222-4230. doi: 10.1002/ehf2.15032. Epub 2024 Aug 18.
The aim of this study was to determine the clinical profile, associated events and safety of vericiguat in a real-world cohort of patients with heart failure with reduced ejection fraction (HFrEF).
This study is a prospective and observational cohort study of patients with HFrEF and recent HF worsening episodes requiring intravenous therapy who initiated vericiguat in an HF outpatient clinic. A subanalysis of patients with ≥6 months' follow-up was performed separately.
Out of 103 patients initially included, 52 had a follow-up of at least 6 months (median follow-up of 303 days). At baseline, the mean age was 71.3 ± 9.4 years, 27.2% were women, the median left ventricular ejection fraction was 34% (28%-39%) and 99% were taking beta-blockers, 96.1% sodium-glucose cotransporter-2 (SGLT2) inhibitors, 95.1% sacubitril-valsartan, 90.3% aldosterone antagonists and 93.2% loop diuretics. During follow-up, New York Heart Association (NYHA) functional class improved (from 67.3% and 32.7% in classes III and II, respectively, to 22.4% and 75.5% at study end; P < 0.001), as did the EuroQol-5D (EQ-5D) and visual analogue scale (VAS) scores (from 0.83 ± 0.13 to 0.87 ± 0.12, P = 0.032, and from 60 to 79, P = 0.005, respectively). Vericiguat was well tolerated (13.5% had symptomatic hypotension, and 11.5% had discontinued treatment), and 78.8% of patients achieved the target dose of 10 mg. The number of HF-related hospitalizations/decompensations within the previous 12 months was 2.3 ± 1.4 and decreased with vericiguat to 0.79 ± 1.14 (P < 0.001). At study end, 7.7% died (50% for HF).
In clinical practice, treatment with vericiguat is associated with substantial improvements in functional class and quality of life and a reduction in hospitalizations for HF, with a low risk of adverse effects.
本研究旨在确定在射血分数降低的心力衰竭（HFrEF）患者的真实世界队列中，维立西呱的临床特征、相关事件及安全性。
本研究是一项对HFrEF且近期因心力衰竭恶化发作需要静脉治疗的患者进行的前瞻性观察性队列研究，这些患者在心力衰竭门诊开始使用维立西呱。对随访时间≥6个月的患者进行了单独的亚组分析。
最初纳入的103例患者中，52例进行了至少6个月的随访（中位随访时间为303天）。基线时，平均年龄为71.3±9.4岁，女性占27.2%，左心室射血分数中位数为34%（28%-39%），99%的患者正在服用β受体阻滞剂，96.1%服用钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂，95.1%服用沙库巴曲缬沙坦，90.3%服用醛固酮拮抗剂，93.2%服用襻利尿剂。随访期间，纽约心脏协会（NYHA）心功能分级有所改善（分别从Ⅲ级和Ⅱ级的67.3%和32.7%改善至研究结束时的22.4%和75.5%；P<0.001），欧洲五维健康量表（EQ-5D）和视觉模拟量表（VAS）评分也有所改善（分别从0.83±0.13提高至0.87±0.12，P=0.032，以及从60提高至79，P=0.005）。维立西呱耐受性良好（13.5%的患者出现症状性低血压，11.5%的患者停止治疗），78.8%的患者达到了10mg的目标剂量。过去12个月内与心力衰竭相关的住院/失代偿次数为2.3±1.4次，使用维立西呱后降至0.79±1.14次（P<0.001）。研究结束时，7.7%的患者死亡（50%死于心力衰竭）。
在临床实践中，使用维立西呱治疗可使心功能分级和生活质量显著改善，心力衰竭住院次数减少，且不良反应风险较低。
