Acute Coronary Syndromes (ACS), Coronary Arterial Disease (CAD), Thin-cap fIbroatheroma, Vulnerable Coronary Plaques
Conditions
Keywords
Optical Coherence Tomography (OCT), Percutaneous Coronary Intervention (PCI), Randomized Controlled Trial (RCT), Optimal Medical Therapy, Drug Eluting Stent (DES), Quantitative Flow Ratio (QFR), Acute Coronary Syndromes (ACS), Vulnerable Coronary Plaques
Brief summary
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.
Interventions
PROCEDUREPCI strategy
-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).
DRUGOMT strategy
* 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.
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria 1. Males or non-pregnant females aged 18-80 years 2. Clinically diagnosed with acute coronary syndrome (including unstable angina, ST-segment elevation myocardial infarction, and non-ST-segment elevation myocardial infarction) 3. Patients willing and able to sign a written informed consent form Angiography, QFR, and OCT Inclusion Criteria 1. Successful completion of angiography, QFR, and OCT examinations 2. Successful treatment of all culprit lesions and flow-limited lesions (QFR ≤ 0.8) 3. Reference vessel diameter between 2.5-4.0 mm on imaging assessment 4. Lesion length ≤40 mm 5. At least one significant stenosis (diameter reduction \>50%) demonstrated by angiography, with QFR \>0.80 and OCT-defined TCFA (fibrous cap thickness \<65μm, lipid arc \>90°)
Exclusion criteria
Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target vessel failure | From enrollment to the end of treatment at 24 months | Composite endpoint of cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization, and hospitalization for unstable or worsening angina. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infarction | From enrollment to the end of treatment at 24 months | 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 | From enrollment to the end of treatment at 24 months | 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 | From enrollment to the end of treatment at 24 months | 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. |
| Intrastent thrombus | From enrollment to the end of treatment at 24 months | Intrastent thrombus: Defined according to the explicit or probable criteria established by the Academic Research Consortium (ARC). |
| Death | From enrollment to the end of treatment at 24 months | 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. |
| Bleeding events | From enrollment to the end of treatment at 24 months | Bleeding events: Events are assessed according to the Bleeding Academic Research Consortium (BARC) criteria. Severe bleeding is defined as BARC grades 3-5. |
| Major adverse cardiovascular events | From enrollment to the end of treatment at 24 months | Major adverse cardiovascular events: cardiovascular death, non-fatal myocardial infarction, or unplanned rehospitalization due to unstable or progressive angina. |
| Patient-oriented outcomes | From enrollment to the end of treatment at 24 months | Patient-oriented outcomes: A composite endpoint comprising death from any cause, myocardial infarction, or repeat revascularization. |
| Angina symptoms | From enrollment to the end of treatment at 24 months | Angina symptoms: Based on the Seattle Angina Scale. |
| Stroke | From enrollment to the end of treatment at 24 months | Stroke: Refers to the sudden onset of neurological dysfunction caused by impaired cerebral blood flow or intracerebral hemorrhage, in the absence of obvious non-vascular causes such as trauma, tumors, or infections. |
Countries
China
Contacts
Primary ContactBoqun SHI
Outcome results
None listed