Study on Risk Factors and Prognostic Value of Non-target Lesion Progression in Patients With Coronary Artery Disease

N/AActive Not RecruitingNCT07748754

Beijing Anzhen Hospital1,400 enrolled

Overview

The goal of this observational study is to explore the risk factors and prognostic value of non-target coronary lesion progression in patients aged 18-80 years with established coronary artery disease who are scheduled for repeat coronary angiography. The main questions it aims to answer are: What clinical, inflammatory and metabolic factors are independently associated with the progression of untreated non-target lesions after percutaneous coronary intervention? Does the initial interventional strategy (drug-eluting stent vs. drug-coated balloon) influence the long-term progression of non-target coronary lesions and subsequent clinical outcomes? Researchers will compare participants treated with drug-eluting stents (DES) and those treated with drug-coated balloons (DCB) at their prior index procedure to see if different local interventional modalities lead to differences in non-target lesion progression and major adverse cardiovascular events during follow-up. Participants will: Undergo clinically indicated repeat coronary angiography, with offline quantitative coronary angiography (QCA) analysis of all coronary segments Provide baseline clinical data, medical history and blood samples for inflammatory and metabolic biomarker testing Complete 3 years of regular clinical follow-up to track lesion evolution and cardiovascular endpoints

Study Type

OBSERVATIONAL

Enrollment

1,400

Conditions

Coronary Artery Disease (CAD)

Interventions

Drug-eluting stents (DES) have markedly reduced the risks of target lesion restenosis and repeat revascularization \[2\]. Nevertheless, the progression of coronary atherosclerosis does not cease after percutaneous coronary intervention (PCI). Clinical evidence demonstrates that even after successful target lesion revascularization and adherence to standardized secondary prevention therapy, patients may still develop progression of non-target lesions (NTLs) during follow-up, which further leads to non-target vessel revascularization, recurrent myocardial infarction, and major adverse cardiovascular events (MACE) \[3\]. This finding indicates that post-PCI risk is not solely driven by severely stenotic target lesions; to a certain extent, it may also arise from initially untreated non-target lesions that harbor progression potential. This issue has become one of the key factors limiting the long-term clinical benefit of patients with coronary artery disease following interventional therapy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria To be eligible for enrollment in this study, participants must meet all of the following criteria: Aged 18 to 80 years, regardless of gender, with full decision-making capacity; Previously diagnosed with coronary artery disease (coronary artery diameter stenosis ≥ 50%) by coronary angiography, and scheduled to undergo repeat coronary angiography; Able to provide written informed consent. Exclusion Criteria Participants will be excluded from the study if they meet any of the following criteria: Undergoing coronary artery bypass grafting (CABG) during the index hospitalization; Poor angiographic image quality (vessel overlap, inadequate opacification) that precludes quantitative coronary angiography (QCA) or Angio FFR analysis; Concomitant severe valvular heart disease, cardiomyopathy, or active infection.

Outcomes

Primary Outcomes

Angiographic Progression of Non-Target Lesions

Quantitative coronary angiography (QCA) will be performed to compare coronary angiographic images obtained at baseline (during the initial percutaneous coronary intervention) and during follow-up. All non-target coronary segments that did not receive initial interventional treatment will be quantitatively measured for luminal diameter stenosis to assess the progression of atherosclerotic lesions. Non-target lesion progression is defined as meeting any of the following criteria: an absolute increase of ≥20% in luminal diameter stenosis in the same non-target segment at follow-up angiography compared with baseline; progression from baseline diameter stenosis \<50% to clinically significant stenosis with diameter stenosis ≥50%; or new-onset atherosclerotic lesions with diameter stenosis ≥50% in non-target segments during follow-up. Based on this endpoint, clinical, inflammatory and metabolic risk factors associated with non-target lesion progression will be analyzed, and the incidence of

Time frame: From baseline interventional procedure to follow-up coronary angiography (median follow-up duration of approximately 12 to 24 months, subject to the timing of routine clinical follow-up angiography); lesion progression-related events will be continuously