The goal of this observational study is to evaluate whether residual cardiovascular risk assessed at 1 month after percutaneous coronary intervention (PCI) is associated with long-term clinical outcomes in adult patients with coronary artery disease who are free from major adverse clinical events at 1 month after PCI. The main questions it aims to answer are: * Does residual cardiovascular risk at 1 month after PCI predict long-term net adverse clinical events? * Which components of residual cardiovascular risk are associated with subsequent adverse clinical outcomes? Participants will: * Undergo comprehensive laboratory testing at 1 month after PCI and annually thereafter. * Undergo artificial intelligence-based quantitative coronary angiographic analysis using DICOM datasets after PCI. * Be followed annually for up to 3 years after the 1-month assessment to evaluate clinical outcomes.
Study Type
OBSERVATIONAL
Enrollment
500
Patients' blood samples are tested at 1 month, and then annually for 3 years post-intervention to assess residual thrombotic, metabolic, and inflammatory risk.
Patients' DICOM dataset is evaluated using artificial intelligence-based quantitative coronary analysis to assess a procedural risk.
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Net adverse clinical event
The composite of cardiovascular death, nonfatal spontaneous (nonprocedural) myocardial infarction, nonfatal ischemic stroke, unplanned hospitalization leading to urgent revascularization, and major bleeding.
Time frame: 3 years after the 1-month assessment (baseline)
Cardiovascular death
The composite of cardiac and vascular death. Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. Death caused by noncoronary vascular causes, such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases will be classified as vascular death.
Time frame: 3 years after the 1-month assessment (baseline)
Nonfatal spontaneous (nonprocedural) myocardial infarction
Myocardial infarction is defined as symptoms, electrocardiographic changes, or abnormal imaging findings, combined with a creatine kinase MB fraction above the upper normal limits or a troponin T or troponin I level greater than the 99th percentile of the upper normal limit. Myocardial infarction that are not associated with a revascularization procedure will be classified as nonfatal spontaneous myocardial infarction.
Time frame: 3 years after the 1-month assessment (baseline)
Nonfatal ischemic stroke
Cerebrovascular event resulting in a neurologic deficit within 24 hours or the presence of acute infarction as demonstrated by imaging studies will be classified as nonfatal ischemic stroke.
Time frame: 3 years after the 1-month assessment (baseline)
Unplanned hospitalization leading to urgent revascularization
This event will be present only if the participant is hospitalized unexpectedly because of persisting or increasing complaints of chest pain (with or without ST-T changes, with or without elevated biomarkers) and a revascularization is performed within the same hospitalization. It should be clearly distinguished from the revascularization procedure which is performed on non-urgent basis.
Time frame: 3 years after the 1-month assessment (baseline)
Major bleeding
Bleeding Academic Research Consortium type 3 or 5
Time frame: 3 years after the 1-month assessment (baseline)
V-Angiographic success
Participant with visually estimated residual diameter stenosis of less than 20% in all PCI-treated lesions
Time frame: 1 month post-intervention
V-Complete revascularization
Participant without angiographically significant stenosis (visually estimated diameter stenosis severity of ≥70% for non-left main disease and ≥50% for left main disease) after PCI in entire coronary arteries
Time frame: 1 month post-intervention
AI-Angiographic success
Participant with artificial intelligence-measured residual diameter stenosis of less than 20% in all PCI-treated lesions
Time frame: 1 month post-intervention
AI-Complete revascularization
Participant without angiographically significant stenosis (artificial intelligence-measured diameter stenosis severity of ≥70% for non-left main disease and ≥50% for left main disease) after PCI in entire coronary arteries
Time frame: 1 month post-intervention
Platelet reactivity
This will be measured with P2Y12 reaction units through VerifyNow test.
Time frame: 1 month post-intervention
Thrombogenicity profiles
This will include R, K, Angle, A10, MA, and Ly30 through thromboelastography.
Time frame: 1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline
Lipid profiles
This will include total cholesterol, high-density lipoprotein, low-density lipoprotein, and lipoprotein (a).
Time frame: 1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline
Hemoglobin A1C
Time frame: 1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline
High-sensitivity C-reactive protein
Time frame: 1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.