Mignone John L, Alexander Kevin M, Dobbles Michael, Eberst Kyle, Fonarow Gregg C, Ellenbogen Kenneth A
Division of Cardiology, Swedish Medical Center, Seattle, Washington.
Division of Cardiovascular Medicine, Department of Medicine, Stanford University, Stanford, California.
Heart Rhythm O2. 2024 Jan 24;5(3):168-173. doi: 10.1016/j.hroo.2024.01.004. eCollection 2024 Mar.
Limited real-world evidence exists for outcomes with contemporary guideline-directed medical therapy (GDMT) or GDMT with implantable cardioverter-defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) therapy for patients with heart failure with reduced ejection fraction (HFrEF) and left ventricular ejection fraction (LVEF) ≤35%.
The present study aimed to assess survival associated with GDMT or GDMT with ICD/CRT-D therapy.
This retrospective observational study included real-world de-identified data from January 1, 2016, to December 19, 2023, from 24 U.S. institutions per participating institutional agreements (egnite Database; egnite, Inc.). Patients with a diagnosis of HFrEF and an echocardiographic study documenting LVEF ≤35% were included for analysis.
Of 43,591 patients with eligible index event of LVEF ≤35%, prescription history through ≥1 year preindex, and no ICD/CRT-D therapy preindex, mean ± standard deviation age at index was 71.2 ± 13.2 years; 14,805 (34.0%) patients were female. At 24 months, an estimated 99.1% (95% confidence interval [CI] 99.0%-99.2%), 89.9% (95% CI 89.7%-90.1%), 54.8% (95% CI 54.4%-55.2%), and 17.2% (95% CI 16.9%-17.5%), had ≥1, 2, 3, or all 4 GDMT classes prescribed, respectively; an estimated 15.7% (95% CI 15.3%-16.1%) had device placement. Of those without a device, by 24 months, an estimated 45.1% (95% CI 44.4%-45.7%) had a documented LVEF >35%. Counts of GDMT classes prescribed as well as ICD/CRT-D device therapy were associated with lower mortality risk in this population, even after adjustment for patient age, sex, and comorbidities.
Both GDMT classes prescribed and device therapy were independently associated with lower mortality risk, even in the presence of more GDMT options for this more contemporary population.
对于射血分数降低的心力衰竭(HFrEF)且左心室射血分数(LVEF)≤35%的患者,采用当代指南指导的药物治疗(GDMT)或GDMT联合植入式心脏复律除颤器(ICD)/心脏再同步治疗除颤器(CRT-D)治疗的结局,现实世界证据有限。
本研究旨在评估与GDMT或GDMT联合ICD/CRT-D治疗相关的生存率。
这项回顾性观察性研究纳入了根据参与机构协议(egnite数据库;egnite公司)从2016年1月1日至2023年12月19日来自美国24家机构的去识别化现实世界数据。纳入诊断为HFrEF且有超声心动图研究记录LVEF≤35%的患者进行分析。
在43591例符合入选标准的LVEF≤35%、入选前≥1年有用药史且入选前未接受ICD/CRT-D治疗的患者中,入选时的平均年龄±标准差为71.2±13.2岁;14805例(34.0%)患者为女性。在24个月时,估计分别有99.1%(95%置信区间[CI]99.0%-99.2%)、89.9%(95%CI 89.7%-90.1%)、54.8%(95%CI 54.4%-55.2%)和17.2%(95%CI 16.9%-17.5%)的患者接受了≥1、2、3或所有4类GDMT药物治疗;估计有15.7%(95%CI 15.3%-16.1%)的患者植入了设备。在未植入设备的患者中,到24个月时,估计有45.1%(95%CI 44.4%-45.7%)的患者记录的LVEF>35%。在该人群中,即使在调整了患者年龄、性别和合并症后,所开GDMT药物类别数量以及ICD/CRT-D设备治疗与较低的死亡风险相关。
所开GDMT药物类别和设备治疗均与较低的死亡风险独立相关,即使对于这一更新的人群有更多的GDMT选择。