Gaggin Hanna K, Greene Stephen J, Zhou Mo, Lautsch Dominik, Bash Lori D, Djatche Laurence, Song Yan, Signorovitch James, Stevenson Andra S, Blaustein Robert O, Butler Javed
Harvard Medical School, Boston, MA, USA.
Cardiology Division, Massachusetts General Hospital, Boston, MA, USA.
Int J Cardiol Cardiovasc Risk Prev. 2024 May 6;21:200278. doi: 10.1016/j.ijcrp.2024.200278. eCollection 2024 Jun.
Based on available data from randomized clinical trials, patients with heart failure with reduced ejection fraction (HFrEF) and worsening HF events (WHFE) have substantial disease burden and poor outcomes. WHFE clinical outcome data in non-clinical trial patients, more representative of the US clinical practice, has not been demonstrated.
CHART-HF collected data from two complementary, non-clinical trial cohort with HFrEF (LVEF <45 %): 1) 1,000 patients from an integrated delivery network and 2) 458 patients from a nationwide physician panel. CHART-HF included patients with WHFE between 2017 and 2019 followed by an index outpatient cardiology visit ≤6 months, and patients without WHFE in a given year between 2017 and 2019, with the last outpatient cardiology visit in the same year as the index visit. Compared to patients without WHFE (after covariate adjustment, all p < 0.05), patients with WHFE had a greater risk of HF-related hospitalization (hazard ratio [HR]: 1.53-2.40) and next WHFE event (HR: 1.67-2.41) following index visits in both cohorts.
HFrEF patients with recent WHFE consistently had worse clinical outcomes in these non-clinical trial cohorts. Despite advances in therapies, unmet need to improve clinical outcomes in HFrEF patients with WHFE remains.
根据随机临床试验的现有数据,射血分数降低的心力衰竭(HFrEF)患者以及心力衰竭事件恶化(WHFE)患者具有相当大的疾病负担且预后较差。尚未证实非临床试验患者中的WHFE临床结局数据,而这些数据更能代表美国的临床实践情况。
CHART-HF研究从两个互补的、非临床试验队列中收集了HFrEF(左心室射血分数<45%)患者的数据:1)来自一个综合医疗服务网络的1000名患者,以及2)来自一个全国性医生小组的458名患者。CHART-HF纳入了2017年至2019年间发生WHFE且在≤6个月内进行了首次门诊心脏病学就诊的患者,以及2017年至2019年某一年中未发生WHFE且最后一次门诊心脏病学就诊时间与首次就诊时间在同一年的患者。与无WHFE的患者相比(在进行协变量调整后,所有p<0.05),两个队列中发生WHFE的患者在首次就诊后发生心力衰竭相关住院的风险更高(风险比[HR]:1.53 - 2.40)以及下一次WHFE事件的风险更高(HR:1.67 - 2.41)。
在这些非临床试验队列中,近期发生WHFE的HFrEF患者临床结局始终较差。尽管治疗取得了进展,但改善发生WHFE的HFrEF患者临床结局的需求仍未得到满足。