Optical Coherence Tomography (OCT) Findings and Coronary Bifurcation Lesions

Nanjing First Hospital, Nanjing Medical University304 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

304

Conditions

Coronary Bifurcation Lesions

Interventions

percutaneous coronary interventionPROCEDURE

percutaneous coronary intervention with drug-eluting stent implantation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Nanjing First Hospital

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

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.

Time frame: Documentation of baseline OCT

Secondary Outcomes

Major Adverse Cardiovascular Events (MACE)

MACE was included myocardial infarction, cardiac death, and target lesion revascularization.

Time frame: 0 to 12 months

Stent Thrombosis

Stent thrombosis was defined according to the Academic Research Consortium definition.

Time frame: 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.

Time frame: 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.

Time frame: 0 to 12 months

Plaque erosion

Plaque erosion is characterized by luminal thrombus and absence of the endothelium, without evidence of fibrous cap disruption.

Time frame: 0 to 12 months

Plaque rupture

Rupture was identified by the presence of fibrous cap discontinuity with a clear cavity formation inside the plaque.

Data from ClinicalTrials.gov

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