The utility of routine HEMAtological indices in prediction of ischemic and hemorrhagic events in patients after Percutaneous Coronary Interventio

• Conditions: I25; I21; Chronic ischaemic heart disease; Acute myocardial infarction

• Registration Number: DRKS00020892
• Lead Sponsor: Semey Medical University, Department of Cardiology and Interventional Arrhythmology

Brief Summary

Introduction Percutaneous coronary interventions (PCI) are often performed in multimorbid patients with heterogeneous characteristics and variable clinical outcomes. We aimed to identify distinct clinical phenotypes utilizing machine learning and explore their relationship with long-term recurrent and weighted outcomes. Methods This prospective observational cohort study enrolled all-comer PCI patients in 2020-2021. Multiple imputation k-means clustering was utilized to detect specific phenotypes. The study endpoints were patient-oriented and device oriented composite endpoints (POCE, DOCE), its individual components, and major bleeding. We applied semiparametric regression models for recurrent and weighted endpoints. Results The study included a total of 643 patients. We unveiled three phenotype clusters: 1) inflammatory (n = 44, with high white blood cell counts, high values of C-reactive protein (CRP) and neutrophil-to-lymphocyte ratio), 2) high erythrocyte sedimentation rate (ESR) (n = 204), and 3) non-inflammatory (n = 395). For ACS-only population, we four distinct phenotypes (high-CRP, high-ESR, high aspartate-aminotransferase, and normal). For all-comer PCI patients, identified phenotypes had a higher risk of POCE (mean ratio (MR) 1.42 (95% confidence interval (CI) 1.11–1.81) and MR 2.01 (95% CI 1.58–2.56), respectively), DOCE (MR 1.61 (95% CI 1.20–2.16), MR 2.60 (95%CI 1.94–3.48), respectively), and stroke (hazard ratio (HR) 2.86 (95% CI 1.10–7.4), 6.83 (95% CI 2.01–23.2)). Similarly, high-ESR and high-CRP phenotypes of ACS patients were significantly associated with the development of clinical composite outcomes. Conclusion Machine learning unveiled three distinct phenotype clusters in patients after PCI that were linked with the risk of recurrent and weighted clinical endpoints.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-18
• Study Completion: 2022-05-31
• Results First Posted: 2022-12-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 643

Inclusion Criteria

consecutive patients with diagnosis of different forms of coronary artery disease (ICD-10 code I20-25) treated with percutaneous coronary intervention.

Exclusion Criteria

1. deny to provide informed consent
2. death during index hospital stay
3. absence of available CBC measurements
4. terminal chronic kidney disease requiring dialysis
5. end-stage liver insufficiency
6. cancer
7. hematological proliferative diseases
8. active infections with thrombocytopenia
9. pregnancy
10. age less than 18 years old
11. patients without active legal competence

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Recurrent patient-oriented weighted composite endpoints with endpoint definitions proposed by the Academic Research Consortium-2 Consensus Document (doi: 10.1161/CIRCULATIONAHA.117.029289). The weights of the individual endpoints will be predefined according to the Delphi panel of experts (doi:10.1093/eurheartj/ehu262).<br><br>2. Recurrent composite endpoint of all-cause mortality, myocardial infarction and stroke with a joint frailty survival model.