Optical Coherence Tomography (OCT) Findings and Coronary Bifurcation Lesions

Study Overview
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Brief Summary
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To determine the clinical prevalence of vulnerable plaque using OCT in patients with coronary bifurcation lesion.

Detailed Description
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This is a prospective registry study in which patient with bifurcation lesion undergoing baseline coronary angiography, baseline OCT and percutaneous coronary intervention will be studied. OCT is used to assess the prevalence of vulnerable plaque, its location at bifurcation lesions and compare vulnerable plaque related major adverse cardiovascular events (MACE) during one-year follow-up in bifurcation lesions between patients with vulnerable plaque and those without. Relationship between endothelial shear stress and vulnerable plaque. Relationship between bifurcation angle and vulnerable plaque. Group A: presence of vulnerable plaque at the bifurcation Group B: absence of vulnerable plaque at the bifurcation Documentation of immediate post stent OCT and 12 months follow up angiography with OCT will be performed. Immediate post stent OCT to assess successful stent implantation and after 12 months follow up to document year major adverse cardiovascular events (MACE) included myocardial infraction, cardiac death and clinically driven target lesion revascularization, stent thrombosis.

Official Title
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Prevalence of Vulnerable Plaque Its Location and Clinical Significance in Bifurcation Lesions Detected by Optical Coherence Tomography.

Conditions
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Coronary Bifurcation Lesions

Intervention / Treatment
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* Procedure: percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years old Patients with ischemic heart disease who are considered for coronary revascularization with PCI True coronary bifurcation lesion Medina 1.1.1, 0.1.1, 1.0.1 (stenosis> 50% by visual estimation) treated by drug-eluting stent Reference vessel diameter of main vessel >= 2.5mm and side branch >=2.0 mm by visual estimation Exclusion Criteria: Saphenous vein grafts In-stent restenotic lesions Thombus-containing lesions Patient who had Myocardial infarction with in less than one month Patent who had bifurcation lesion dilation with balloon Contraindication or hypersensitivity to anti-platelet agents or contrast media Creatinine level ≥ 2.0 mg/dL Severe hepatic dysfunction (3 times normal reference values) Hemodynamic unstable patients Inability of OCT devise to cross the lesion into distal vessel Pregnant women or women with potential childbearing Inability to understand or read the informed content

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vulnerable plaque<br>Thin-cap fibro atheroma (TCFA) was defined as a lipid-rich plaque with the thinnest fibrous cap thickness<65um. Plaque rupture was identified by the presence of fibrous cap discontinuity with a clear cavity formation inside the plaque. Plaque erosion is characterized by luminal thrombus and absence of the endothelium or without evidence of fibrous cap disruption. Fibro calcific plaque contains OCT evidence of fibrous tissue along with calcium that appears as a signal-poor or heterogeneous region with a sharply delineated border which is applied to larger calcifications. Calcified nodule is characterized as a signal or multiple regions of calcium protruding into the lumen, superficial calcification accompanied by substantive calcium proximal and or distal to the lesion. Thrombus is defined as a mass attached to luminal surface or floating within the lumen. It is seen as a protrusion inside the lumen of the artery with signal attenuation. | Procedure: percutaneous coronary intervention<br>* percutaneous coronary intervention with drug-eluting stent implantation.<br>* Other names: PCI;|
| Active Comparator: Without any vulnerable plaqueStable plaque<br>patient with bifurcation lesion undergoing baseline coronary angiography and baseline OCT. | Procedure: percutaneous coronary intervention<br>* percutaneous coronary intervention with drug-eluting stent implantation.<br>* Other names: PCI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of coronary vulnerable plaques in bifurcation lesions using coherence tomography (OCT) | Vulnerable plaque was considered when presence of Thin-cap fibro atheroma (TCFA), Lipid-rich plaque (vulnerable), Plaque rupture, Plaque erosion, thrombus and calcified nodule. | Documentation of baseline OCT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events (MACE) | MACE was included myocardial infarction, cardiac death, and target lesion revascularization. | 0 to 12 months | 
| Stent Thrombosis | Stent thrombosis was defined according to the Academic Research Consortium definition. | 0 to 12 months | 
| Thin-cap fibroatheroma | Thin-cap fibroatheroma was defined as a lipid-rich plaque with the thinnest fibrous cap thickness < 65 µm. | 0 to 12 months | 
| Calcified nodule | Calcified nodule is characterized as a signal or multiple regions of calcium protruding into the lumen, superficial calcification accompanied by substantive calcium proximal and or distal to the lesion. | 0 to 12 months | 
| Plaque erosion | Plaque erosion is characterized by luminal thrombus and absence of the endothelium, without evidence of fibrous cap disruption. | 0 to 12 months | 
| Plaque rupture | Rupture was identified by the presence of fibrous cap discontinuity with a clear cavity formation inside the plaque. | 0 to 12 months | 
| Thrombus | Thrombus is defined as a mass attached to luminal surface or floating within the lumen. It is seen as a protrusion inside the lumen of the artery with signal attenuation. | 0 to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary bifurcation lesion, optical coherence tomography, vulnerable plaque