DETErmination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents(EES) Versus Biolimus A9-eluting Stents(BES)

Study Overview
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Brief Summary
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The purpose of the study is 1> to compare neointimal stent coverage after OCT-guided vs. Angio-guided PCI, 2> to compare neointimal stent coverage at 3 months after EES vs BES implantation, 3> to determine the duration of dual antiplatelet therapy by OCT measurement at 3 months

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Device: Angio-guided PCI with EES or BES
* Device: OCT-guided PCI with EES or BES
* Device: PCI with BES under angio-guide or OCT guide
* Device: PCI with EES under angio-guide or OCT guide
* Drug: Keep DAPT
* Drug: Discontinue DAPT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 20 years old Patients with ischemic heart disease who are considered for coronary revascularization with stent implantation. Significant coronary de novo lesion (stenosis > 70% by quantitative angiographic analysis) treated by single DES ≤ 25mm Reference vessel diameter of 2.5 to 3.5 mm by operator assessment Exclusion Criteria: Complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis Reference vessel diameter < 2.5 mm or > 4.0mm Heavy calcified lesions (definite calcified lesions on angiogram) Primary PCI for STEMI Contraindication to anti-platelet agents Treated with any DES within 3 months at other vessel Creatinine level ≥ 2.0 mg/dL or ESRD Severe hepatic dysfunction (3 times normal reference values) Pregnant women or women with potential childbearing Life expectancy < 1 year

Ages Eligible for Study
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Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Angio guided PCI<br> | Device: Angio-guided PCI with EES or BES<br>* Angio-guided intervention<br>|
| Experimental: OCT-guided PCI<br> | Device: OCT-guided PCI with EES or BES<br>* OCT-guided intervention<br>|
| Active Comparator: BES<br> | Device: PCI with BES under angio-guide or OCT guide<br>* biolimus A9-eluting stent.<br>|
| Experimental: EES<br> | Device: PCI with EES under angio-guide or OCT guide<br>* everolimus eluting stent.<br>|
| Active Comparator: Keep dual antiplatelet therapy (DAPT)<br>Study subjects will be allocated into this arm with non-randomization method | Drug: Keep DAPT<br>* maintain DAPT for 12 months according to level of uncovered strut (>6%) at 3months OCT follow up after stent implantation.<br>|
| Active Comparator: Discontinue Dual antiplatelet therapy (DAPT)<br>Study subjects will be allocated into this arm with non-randomization method | Drug: Discontinue DAPT<br>* discontinue DAPT according to level of uncovered strut (≤6%) at 3months OCT follow up after stent implantation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of neointimal coverage at 3 month-OCT after stent implantation |  | at 3 month-OCT after stent implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of the composite of cardiac death, MI, definite or probable stent thrombosis, and TIMI-defined major bleeding for 12 months |  | 12 months after PCI | 
| percentage of malposition strut at 3 month-OCT after stent implantation |  | 3 months after PCI | 
| The occurrence of the composite of All cause death, spontaneous MI, Target vessel revascularization and stroke. |  | 12 months after PCI | 
| Target vessel revascularization |  | 12 months after PCI | 
| TIMI-defined major bleeding for 12 months |  | 12 months after PCI |