Thromb Haemost 2023; 123(01): 085-096
DOI: 10.1055/a-1932-8854
Stroke, Systemic or Venous Thromboembolism

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

Wengen Zhu
1   Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China
2   NHC Key Laboratory of Assisted Circulation, Guangzhou, People's Republic of China
3   National-Guangdong Joint Engineering Laboratory for Diagnosis and Treatment of Vascular Diseases, Guangzhou, People's Republic of China
,
Yalin Cao
4   Department of Cardiology, Guizhou Provincial People's Hospital, Guiyang, People's Republic of China
,
Min Ye
1   Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China
2   NHC Key Laboratory of Assisted Circulation, Guangzhou, People's Republic of China
,
Huiling Huang
1   Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China
,
Yuzhong Wu
1   Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China
,
Jianyong Ma
5   Department of Pharmacology and Systems Physiology, University of Cincinnati College of Medicine, Cincinnati, Ohio, United States
,
Yugang Dong
1   Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China
2   NHC Key Laboratory of Assisted Circulation, Guangzhou, People's Republic of China
3   National-Guangdong Joint Engineering Laboratory for Diagnosis and Treatment of Vascular Diseases, Guangzhou, People's Republic of China
,
Xiao Liu
6   Department of Cardiology, Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China
,
Chen Liu
1   Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China
2   NHC Key Laboratory of Assisted Circulation, Guangzhou, People's Republic of China
3   National-Guangdong Joint Engineering Laboratory for Diagnosis and Treatment of Vascular Diseases, Guangzhou, People's Republic of China
,
Gregory Y. H. Lip
7   Liverpool Centre for Cardiovascular Sciences, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom
8   Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
› Author Affiliations
Funding This study was funded by the National Natural Science Foundation of China (82100273, 82100347), China Postdoctoral Science Foundation (2020M673016, 2021M703724), and Natural Science Foundation of Guangdong Province (2022A1515010582)


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.

Ethics Approval and Consent to Participate

The TOPCAT trial was conducted according to the Declaration of Helsinki and approved by the local institutional review boards of all participating institutions. All participants provided written informed consent before enrollment.


* Senior authors.


Supplementary Material



Publication History

Accepted Manuscript online:
29 August 2022

Article published online:
07 November 2022

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