Coronary artery disease remains a leading cause of global mortality. Although percutaneous coronary intervention (PCI) improves patient outcomes, the long-term risk of major adverse cardiovascular events (MACE) driven by the progression of non-target lesions (NTLs) remains substantial and continues to increase, while current risk stratification tools remain inadequate for predicting NTL progression. This multicenter cohort study aims to develop an artificial intelligence (AI)-driven system for the dynamic prediction and precision stratification of NTL progression after PCI. Utilizing comprehensive multimodal data from 52,577 Chinese patients-including clinical profiles, multi-omics blood biomarkers, and coronary imaging-the research pursues three primary objectives: (1) to identify and validate 2-3 specific biomarkers for NTL progression risk using multi-omics approaches; (2) to construct an integrated risk assessment and early-warning system by applying machine learning to multimodal data for predicting NTL progression and MACE; and (3) to establish metabolic and imaging-based subtypes to create a precision management system that optimizes secondary prevention strategies by identifying specific high-risk populations. This study is expected to provide a novel tool for accurate identification of high-risk patients and personalized post-PCI management, ultimately aiming to improve long-term prognosis.
Study Type
OBSERVATIONAL
Enrollment
12,000
Percutaneous coronary intervention (PCI) represents a cornerstone therapeutic approach for coronary artery disease. This minimally invasive procedure involves vascular access typically through the radial or femoral artery, enabling the navigation of catheters and specialized devices to the culprit coronary lesion. The primary objective is to restore optimal coronary blood flow by addressing the obstructive lesion. The intervention encompasses various techniques including balloon angioplasty, stent implantation, and adjunctive procedures such as coronary atherectomy and thrombus aspiration when clinically indicated.
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGComposite endpoint of NTL progression-related myocardial infarction or revascularization
1. NTL progression-related myocardial infarction was defined in accordance with the fourth universal definition of myocardial infarction due to any segment of the nontarget vessel or lesion. 2. NTL progression-related revascularization was defined as revascularization driven by angina or ischemia, either PCI or CABG, of any segment of the nontarget vessel or lesion.
Time frame: 12 month follow-up
Qualitative data on NTL progression
The following conditions are defined as NTL progression: (1) NCL stenosis ≥50% at baseline PCI with ≥10% NCL progression at angiographic follow-up; (2) NCL stenosis \<50% at baseline PCI with ≥30% NCL progression at angiographic follow-up; (3) NCL progression ≥30% without NCL at baseline PCI; (4) NCL progression to complete occlusion. Quantitative data for NTL progression (QCA) are obtained by analyzing coronary angiographic images to determine lesion progression.
Time frame: 12 month follow-up
Quantitative data on NTL progression
QCA analyzes coronary angiography images to determine the progression of lesions: Coronary angiography was evaluated by two independent cardiologists who were unaware of all other clinical data of the patients, using the MEDCON TCS QCA software. First, the edges of the contrast-enhanced vessels were delineated using an automatic edge detection algorithm. After identifying the starting and ending points on the enhanced coronary images, a vascular path was created. Subsequently, the vessel contour was drawn along the path. The path and vessel contour were automatically determined based on contrast density, with occasional manual editing required by the analysts. Measured variables included minimum lumen diameter and degree of lumen stenosis (minimum lumen diameter/adjacent contrast vessel diameter).
Time frame: 12 month follow-up
NTL progression-related myocardial infarction
NTL progression-related myocardial infarction was defined in accordance with the fourth universal definition of myocardial infarction due to any segment of the nontarget vessel or lesion.
Time frame: 12 month follow-up
NTL progression-related revascularization
NTL progression-related revascularization was defined as revascularization driven by angina or ischemia, either PCI or CABG, of any segment of the nontarget vessel or lesion.
Time frame: 12 month follow-up
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