背景:我们根据试验调查了真实世界心力衰竭(HF)人群的Vericiguat资格,准则和标签标准。
方法:来自瑞典HF注册表,2000年至2018年期间纳入23,573例HFrEF患者,HF持续时间≥6个月,被考虑。Vericiguat的资格是根据以下标准计算的:1)在心力衰竭和射血分数降低的受试者中的Vericiguat全球研究(VICTORIA)试验;2)欧洲和美国HF指南;3)根据食品药品监督管理局和欧洲药品管理局的产品标签。
结果:试验中Vericiguat的估计合格性,指导方针,标签场景为21.4%,47.4%和47.4%,分别。在6个月内之前的HF住院是所有情况中限制资格最多的标准(49.1%的人口满足)。在审判场景中,其他有意义限制入选的标准包括N末端B型利钠肽前体水平升高和硝酸盐使用.在所有情况下,基线时因HF住院的患者的资格较高(44.3%vs.21.4%[试验方案]和97.3%与47.4%[指南/标签方案]用于住院与住院非住院患者,分别)。总的来说,符合条件的患者年龄较大,有更严重的HF,更多的合并症,因此,与所有不合格患者相比,CV死亡率和HF住院率更高。
结论:在一个庞大而现代的现实世界HFrEF队列中,根据VICTORIA试验选择标准,我们估计21.4%的患者符合Vericiguat的条件,47.4%基于指南和标签。Vericiguat的资格转化为选择发病率/死亡率高的人群。本文受版权保护。保留所有权利。
We investigated the eligibility for vericiguat in a real-world heart failure (HF) population based on trial,
guideline and
label criteria.
From the Swedish HF registry, 23 573 patients with HF with reduced ejection fraction (HFrEF) enrolled between 2000 and 2018, with a HF duration ≥6 months, were considered. Eligibility for vericiguat was calculated based on criteria from (i) the Vericiguat Global Study in Subjects with Heart Failure and Reduced Ejection Fraction (VICTORIA) trial; (ii) European and American guidelines on HF; (iii) product labelling according to the Food and Drug Administration and European Medicines Agency. Estimated eligibility for vericiguat in the trial,
guidelines, and
label scenarios was 21.4%, 47.4%, and 47.4%, respectively. Prior HF hospitalization within 6 months was the criterion limiting eligibility the most in all scenarios (met by 49.1% of the population). In the trial scenario, other criteria meaningfully limiting eligibility were elevated N-terminal pro-B-type natriuretic peptide levels and nitrate use. In all scenarios, eligibility was higher among patients hospitalized for HF at baseline (44.3% vs. 21.4% [trial scenario] and 97.3% vs. 47.4% [
guideline/
label scenarios] for hospitalized vs. non-hospitalized patients). Overall, eligible patients were older, had more severe HF, more comorbidities, and consequently higher cardiovascular mortality and HF hospitalization rates compared with ineligible patients across all scenarios.
In a large and contemporary real-world HFrEF cohort, we estimated that 21.4% of patients would be eligible for vericiguat according to the VICTORIA trial selection criteria, 47.4% based on guidelines and labelling. Eligibility for vericiguat translated into the selection of a population at high risk of morbidity/mortality.