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开发和外部验证预测 PARADIGM-HF 和 ATMOSPHERE 心衰射血分数降低患者心源性猝死和泵衰竭死亡的预后模型。

Development and external validation of prognostic models to predict sudden and pump-failure death in patients with HFrEF from PARADIGM-HF and ATMOSPHERE.

机构信息

Division of Medicine, Hangzhou Normal University, Hangzhou, China.

British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, UK.

出版信息

Clin Res Cardiol. 2021 Aug;110(8):1334-1349. doi: 10.1007/s00392-021-01888-x. Epub 2021 Jun 8.

DOI:10.1007/s00392-021-01888-x
PMID:34101002
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8318968/
Abstract

BACKGROUND

Sudden death (SD) and pump failure death (PFD) are the two leading causes of death in patients with heart failure and reduced ejection fraction (HFrEF).

OBJECTIVE

Identifying patients at higher risk for mode-specific death would allow better targeting of individual patients for relevant device and other therapies.

METHODS

We developed models in 7156 patients with HFrEF from the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure (PARADIGM-HF) trial, using Fine-Gray regressions counting other deaths as competing risks. The derived models were externally validated in the Aliskiren Trial to Minimize Outcomes in Patients with Heart Failure (ATMOSPHERE) trial.

RESULTS

NYHA class and NT-proBNP were independent predictors for both modes of death. The SD model additionally included male sex, Asian or Black race, prior CABG or PCI, cancer history, MI history, treatment with LCZ696 vs. enalapril, QRS duration and ECG left ventricular hypertrophy. While LVEF, ischemic etiology, systolic blood pressure, HF duration, ECG bundle branch block, and serum albumin, chloride and creatinine were included in the PFD model. Model discrimination was good for SD and excellent for PFD with Harrell's C of 0.67 and 0.78 after correction for optimism, respectively. The observed and predicted incidences were similar in each quartile of risk scores at 3 years in each model. The performance of both models remained robust in ATMOSPHERE.

CONCLUSION

We developed and validated models which separately predict SD and PFD in patients with HFrEF. These models may help clinicians and patients consider therapies targeted at these modes of death.

TRIAL REGISTRATION NUMBER

PARADIGM-HF: ClinicalTrials.gov NCT01035255, ATMOSPHERE: ClinicalTrials.gov NCT00853658.

摘要

背景

心力衰竭伴射血分数降低(HFrEF)患者的主要死亡原因是心源性猝死(SD)和泵衰竭死亡(PFD)。

目的

识别具有特定模式死亡风险较高的患者,将有助于针对个体患者进行相关器械和其他治疗。

方法

我们使用 Fine-Gray 回归分析将其他死亡作为竞争风险,在 Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure(PARADIGM-HF)试验的 7156 例 HFrEF 患者中建立模型,该试验采用阿利西尤单抗与依那普利进行前瞻性比较,以确定心力衰竭患者的全球死亡率和发病率的影响。所建立的模型在 Aliskiren Trial to Minimize Outcomes in Patients with Heart Failure(ATMOSPHERE)试验中进行了外部验证。

结果

纽约心脏协会(NYHA)心功能分级和 N 末端 B 型利钠肽前体(NT-proBNP)是两种死亡模式的独立预测因素。SD 模型还包括男性、亚洲或黑人种族、既往冠状动脉旁路移植术(CABG)或经皮冠状动脉介入治疗(PCI)、癌症史、心肌梗死(MI)史、与依那普利相比使用 LCZ696 治疗、QRS 持续时间和心电图左心室肥厚。而 LVEF、缺血病因、收缩压、HF 持续时间、心电图束支传导阻滞、血清白蛋白、氯和肌酐则纳入 PFD 模型。经校正后,SD 模型的区分度良好,C 指数为 0.67,PFD 模型的区分度极好,C 指数为 0.78。在每个模型中,在每个风险评分四分位的 3 年时,观察到的和预测的发生率相似。在 ATMOSPHERE 试验中,两种模型的性能仍然稳健。

结论

我们建立并验证了可分别预测 HFrEF 患者 SD 和 PFD 的模型。这些模型可能有助于临床医生和患者考虑针对这些死亡模式的治疗。

试验注册

PARADIGM-HF:ClinicalTrials.gov NCT01035255,ATMOSPHERE:ClinicalTrials.gov NCT00853658。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a430/8318968/b6650b80fca4/392_2021_1888_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a430/8318968/d95148bd177b/392_2021_1888_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a430/8318968/85018f76249e/392_2021_1888_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a430/8318968/b6650b80fca4/392_2021_1888_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a430/8318968/d95148bd177b/392_2021_1888_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a430/8318968/85018f76249e/392_2021_1888_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a430/8318968/b6650b80fca4/392_2021_1888_Fig3_HTML.jpg

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