The aim of this clinical trial is to explore the optimal preventative treatment strategy for non-flow-limiting vulnerable plaques. The main question it aims to answer is:
Can interventional therapy further improve the outcome of non-flow-limiting vulnerable plaques on top of optimal pharmacologic therapy?
Researchers will randomly assign patients who meet the inclusion criteria to preventative intervention plus optimal drug therapy (experimental group) or optimal drug therapy alone (control group).
Participants will:
Assigned to the control group: optimized drug therapy consisting of lifestyle improvement and intensive drug therapy including high-dose statin or other therapy to achieve target levels (low-density lipoprotein cholesterol \<1.4 mmol/L and decreased by 50% compared to the baseline). Lifestyle improvement and risk factor management included smoking cessation, nutritional optimization, physical activity, compliance with prescribed medications, and control of diabetes and hypertension.
Assigned to the experimental group: all non-flow-limiting vulnerable plaques were treated with conventional second-generation drug-eluting stents. After the procedure, participants received dual antiplatelet therapy for about 12 months as well as other medications in the control group.
Successful completion of angiography, QFR, and OCT examinations
Successful treatment of all culprit lesions and flow-limited lesions (QFR ≤ 0.8)
Reference vessel diameter between 2.5-4.0 mm on imaging assessment
Lesion length ≤40 mm
Patients with contraindications to dual antiplatelet therapy (DAPT) or planning to discontinue DAPT within one year
Patients with other major illnesses and a life expectancy <2 years
Patients scheduled for cardiac surgery or major non-cardiac surgery
Women who are breastfeeding, pregnant, or planning pregnancy during the study
Parallel
PCI strategy
Procedure/Surgery-In the intervention group, vulnerable plaque lesions (quantitative flow ratio, QFR \>0.8) to be treated at the operator's discretion using second-generation drug eluting stent (DES).
OMT strategy
Drug* Lifestyle modifications and intensive medical therapy (based on current guideline-directed secondary prevention). * Both groups to receive statin or other therapies to achieve LDL-C \<1.4 mmol/L and decrease by 50% compared to the baseline. * Lifestyle and risk factor management to include smoking cessation, nutritional optimization, physical activity, adherence to prescribed medications, and control of diabetes and hypertension.
Target vessel failure
Composite endpoint of cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization, and hospitalization for unstable or worsening angina.
Death
Including all-cause mortality, cardiovascular mortality, or non-cardiovascular mortality. All-cause mortality: Deaths classified as cardiac, non-cardiac, or of unknown cause. Cardiovascular mortality: Deaths due to direct cardiac causes (e.g., acute myocardial infarction, congestive heart failure, fatal arrhythmia), sudden cardiac death, and all deaths related to surgery or concomitant treatment. Non-cardiovascular mortality: Deaths definitively attributed to non-cardiac disease.
Myocardial infarction
Including spontaneous myocardial infarction, perioperative myocardial infarction, and target vessel or non-target vessel-related myocardial infarction. Myocardial infarction: Based on the Fourth Edition Global Myocardial Infarction Definition Criteria. Spontaneous myocardial infarction: Includes types 1, 2, 4b, and 4c in the Fourth Edition Global Myocardial Infarction Classification. Perioperative myocardial infarction: Includes types 4a and 5 in the fourth edition of the Global Myocardial Infarction Classification. Target vessel myocardial infarction: Refers to ischemic necrosis of myocardial tissue supplied by the target vessel where a stent was implanted, resulting from in-stent thrombosis, restenosis, or other causes following coronary intervention. Non-target vessel myocardial infarction: Refers to ischemic necrosis in the corresponding myocardial region following coronary intervention due to obstruction or spasm in a non-target vessel.
Revascularization
Revascularization refers to repeat percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). All revascularization events will be classified as either ischemia-driven or non-ischemia-driven. A revascularization will be considered ischemia-driven if, upon coronary angiography, the re-implanted coronary segment exhibits ≥50% diameter stenosis and meets any one of the following ischemia-related criteria: a) History of chest pain (potentially related to the target vessel) b) Electrocardiographic changes at rest or objective evidence of ischemia during exercise testing or equivalent conditions (potentially related to the target vessel) c) Abnormal results from any invasive functional diagnostic test such as FFR
Hospitalization for any cause
Hospitalization for any cause: Refers to a patient being admitted to an inpatient ward or emergency department with a minimum hospital stay of 24 hours. Additionally, the reason for readmission will be classified based on any cause, cardiac cause, or non-cardiac cause.
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