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埃森卒中风险评分可预测射血分数保留的心力衰竭患者的临床结局:来自TOPCAT试验的证据。

Essen Stroke Risk Score Predicts Clinical Outcomes in Heart Failure Patients with Preserved Ejection Fraction: Evidence from the TOPCAT trial.

作者信息

Zhu Wengen, Cao Yalin, Ye Min, Huang Huiling, Wu Yuzhong, Ma Jianyong, Dong Yugang, Liu Xiao, Liu Chen, Lip Gregory Y H

机构信息

Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China.

NHC Key Laboratory of Assisted Circulation, Guangzhou, People's Republic of China.

出版信息

Thromb Haemost. 2023 Jan;123(1):85-96. doi: 10.1055/a-1932-8854. Epub 2022 Aug 29.

DOI:10.1055/a-1932-8854
PMID:36037830
Abstract

BACKGROUND

Heart failure (HF) with preserved ejection fraction (HFpEF) is associated with increased risks of stroke and other adverse outcomes.

AIMS

This study sought to determine whether the Essen Stroke Risk Score (ESRS) could predict the risks of adjudicated clinical outcomes in patients with HFpEF from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial.

METHODS

We evaluated associations of baseline ESRS with clinical outcomes by using the Cox proportional hazard model with competing risk regression. The diagnostic accuracy of the ESRS was assessed using the C-index and calibration data.

RESULTS

Of 3,441 HFpEF patients with a mean follow-up of 3.3 years, the risk of stroke ranged from 0.32% per year at an ESRS of 1 to 2 points to 1.71% per year at a score of ≥6 points. Each point increase in ESRS was associated with increased risks of primary composite outcome (hazard ratios [HRs] = 1.31; 95% confidence intervals [CIs]: 1.23-1.40; C-index = 0.68), stroke (HR = 1.33 [95% CI: 1.16-1.53]; C-index = 0.68), myocardial infarction (HR = 1.60 [95% CI: 1.40-1.83]; C-index = 0.75), HF hospitalization (HR = 1.30 [95% CI: 1.20-1.41]; C-index = 0.71), any hospitalization (HR = 1.20, 95% CI: 1.15-1.26; C-index = 0.68), cardiovascular death (HR = 1.32 [95% CI: 1.20-1.44]; C-index = 0.68), and all-cause death (HR = 1.37, [95% CI: 1.28-1.48]; C-index = 0.68). The calibration curves showed that the ESRS had a better agreement between predicted and observed stroke risks compared with the R2CHADS2, CHADS2, or CHA2DS2-VASC stroke scores.

CONCLUSION

The ESRS had modest discriminatory abilities for predicting stroke as well as other adverse outcomes including myocardial infarction, hospitalization, and death in HFpEF patients. ESRS might have better calibration performance than R2CHADS2, CHADS2, or CHA2DS2-VASC in HFpEF at high risk for stroke.

CLINICAL TRIAL REGISTRATION

URL: https://clinicaltrials.gov. Unique identifier: NCT00094302.

摘要

背景

射血分数保留的心力衰竭(HFpEF)与中风及其他不良结局风险增加相关。

目的

本研究旨在确定埃森中风风险评分(ESRS)能否预测醛固酮拮抗剂治疗射血分数保留心力衰竭(TOPCAT)试验中HFpEF患者经判定的临床结局风险。

方法

我们使用Cox比例风险模型和竞争风险回归评估基线ESRS与临床结局的关联。使用C指数和校准数据评估ESRS的诊断准确性。

结果

在3441例平均随访3.3年的HFpEF患者中,中风风险从ESRS为1至2分时的每年0.32%到≥6分时的每年1.71%不等。ESRS每增加1分,主要复合结局风险增加(风险比[HRs]=1.31;95%置信区间[CIs]:1.23 - 1.40;C指数=0.68),中风风险增加(HR = 1.33[95%CI:1.16 - 1.53];C指数=0.68),心肌梗死风险增加(HR = 1.60[95%CI:1.40 - 1.83];C指数=0.75),心力衰竭住院风险增加(HR = 1.30[95%CI:1.20 - 1.41];C指数=0.71),任何住院风险增加(HR = 1.20,95%CI:1.15 - 1.26;C指数=0.68),心血管死亡风险增加(HR = 1.32[95%CI:1.20 - 1.44];C指数=0.68),全因死亡风险增加(HR = 1.37,[95%CI:1.28 - 1.48];C指数=0.68)。校准曲线显示,与R2CHADS2、CHADS2或CHA2DS2 - VASC中风评分相比,ESRS在预测和观察到的中风风险之间具有更好的一致性。

结论

ESRS在预测HFpEF患者中风以及包括心肌梗死、住院和死亡在内的其他不良结局方面具有中等鉴别能力。在中风高风险的HFpEF患者中,ESRS可能比R2CHADS2、CHADS2或CHA2DS2 - VASC具有更好的校准性能。

临床试验注册

网址:https://clinicaltrials.gov。唯一标识符:NCT00094302。

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