Division of Cardiology, Duke University School of Medicine, Durham, North Carolina, USA.
Duke Clinical Research Institute, Durham, North Carolina, USA.
JACC Heart Fail. 2023 Feb;11(2):211-223. doi: 10.1016/j.jchf.2022.11.007.
In January 2021, vericiguat, a soluble guanylate cyclase stimulator, was approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of cardiovascular death and heart failure (HF) hospitalization among patients with a recent worsening HF event based on the VICTORIA (VerICiguaT Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) trial.
This study sought to leverage a contemporary U.S. registry of patients hospitalized for heart failure (HF) to characterize patients who may be candidates for vericiguat based on FDA label and the VICTORIA trial eligibility criteria.
The authors studied patients hospitalized for HF with ejection fraction (EF) <45% across 525 sites in the GWTG-HF (Get With The Guidelines-Heart Failure) registry between January 2014 and December 2020. Approximate FDA label criteria (excluding estimated glomerular filtration rate [eGFR] <15 mL/min/1.73 m, dialysis, or patients with heart transplantation or durable mechanical circulatory support) and eligibility criteria for the VICTORIA trial were applied to the GWTG-HF cohort.
Among 241,057 patients with EF <45% in the GWTG-HF registry, 221,730 (92%) could be candidates for vericiguat under the FDA label and 92,249 (38%) would have been eligible for the VICTORIA trial. The most frequent reasons for ineligibility for the FDA label were eGFR <15 mL/min/1.73 m (5.7%) and dialysis (1.6%). Although there were greater proportions of women and Black patients in the GWTG-HF registry, most clinical characteristics were qualitatively similar with patients enrolled in the VICTORIA trial. Among Medicare beneficiaries in the GWTG-HF registry eligible for vericiguat by either FDA label or VICTORIA trial criteria, 12-month postdischarge rates of mortality (36%-37%), HF hospitalization (33%-35%), all-cause hospitalization (64%-66%), and mean health care expenditure (U.S. $25,106-$25,428) were high.
Data from a large, contemporary U.S. registry of patients actively hospitalized for HF with EF <45% suggest that approximately 4 in 10 patients meet the criteria of the VICTORIA trial and that more than 9 in 10 patients are potential candidates for vericiguat based on the FDA label. Contemporary Medicare beneficiaries hospitalized for HF with EF <45% and eligible for vericiguat face high rates of postdischarge mortality and readmission and accrue substantial health care costs.
2021 年 1 月，可溶性鸟苷酸环化酶刺激剂维立西呱（vericiguat）获美国食品和药物管理局（FDA）批准，用于降低近期心力衰竭恶化事件患者的心血管死亡和心力衰竭（HF）住院风险，其临床试验为 VICTORIA 研究。
本研究旨在利用美国当代心力衰竭住院患者注册数据库（GWTG-HF），根据 FDA 标签和 VICTORIA 试验入选标准，确定可能适合维立西呱治疗的患者人群。
作者分析了 2014 年 1 月至 2020 年 12 月期间，在 GWTG-HF（Get With The Guidelines-Heart Failure）注册数据库中 525 个地点因射血分数（EF）<45%而住院的心力衰竭（HF）患者。研究纳入了 GWTG-HF 队列中符合 FDA 标签（不包括估计肾小球滤过率[eGFR] <15 mL/min/1.73 m、透析或心脏移植或持久机械循环支持的患者）和 VICTORIA 试验入选标准的患者。
在 GWTG-HF 注册数据库中，EF<45%的 241057 例患者中，221730 例（92%）符合 FDA 标签的维立西呱适用条件，92249 例（38%）符合 VICTORIA 试验入选标准。不符合 FDA 标签的最常见原因是 eGFR<15 mL/min/1.73 m（5.7%）和透析（1.6%）。尽管 GWTG-HF 注册数据库中的女性和黑人患者比例较高，但大多数临床特征与 VICTORIA 试验入选患者相似。在 GWTG-HF 注册数据库中，符合 FDA 标签或 VICTORIA 试验入选标准的 Medicare 受益人群中，12 个月的死亡率（36%-37%）、HF 住院率（33%-35%）、全因住院率（64%-66%）和平均医疗费用（25106-25428 美元）较高。
来自美国当代心力衰竭 EF<45%患者住院治疗大型注册数据库的数据表明，大约每 10 例患者中有 4 例符合 VICTORIA 试验入选标准，9 例以上患者符合 FDA 标签的维立西呱适用条件。EF<45%且符合维立西呱使用条件的当代 Medicare 受益人群出院后死亡率和再入院率较高，且医疗费用较高。
