Serial EValuation of multiplE Coronary Artery Diseases by an Optical Coherence Tomography; Assessment of the Changes of de Novo Lesions and Comparisons of Neointimal Coverage Between Xience Prime® Versus Cypher SelectTM Stents; SEVEN-Xience Study

Study Overview
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Brief Summary
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This study is a prospective open-labeled, randomized study to compare the neointimal coverage at 3 months and 12 months and its serial changes between 3 months and 12 months according to the implanted DES and evaluate the serial changes in the proximal portions of 3 epicardial coronary artery and left main artery including the assessment of fibrous cap thickness and lipid pool for vulnerable plaques by OCT. In addition, the investigators will compare the changes such as plaques and neointimal coverage from serial OCT follow-up according to the different statin strategy.

Conditions
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Multi-vessel Diseases, Angina

Intervention / Treatment
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* Device: Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL)
* Device: Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA)
* Drug: Pravastatin 20mg
* Drug: Atorvastatin 40mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥ 20 years old Patients with typical angina who are considered for coronary revascularization. Multi-vessel diseases: more than 2 significant coronary de novo lesions (> 70% by quantitative angiographic analysis); one of the target lesions is the most significant tight stenotic lesion causing the ischemic symptom and requiring the immediate revascularization but the others are significant but non-tight lesions to be delayed or observed for 3 months and not requiring immediate PCI for the complete revascularization of all coronary arteries. Exclusion Criteria: ST-elevation MI Cardiogenic shock or hemodynamically unstable status Lesions requiring the immediate complete revascularization of all coronary stenotic lesions Contraindication to anti-platelet agents Treated with any DES within 6 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 Complex lesion morphologies (bifurcation lesions treated with 2-stent techniques, untreated significant unprotected left main diseases, chronic total occlusion, in-stent restenosis, and vein graft lesion)

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: Cypher group<br> | Device: Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL)<br>* Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; Xience Prime® vs. Cypher SelectTM and pravastatin 20mg vs. atorvastatin 40mg.<br>|
| Experimental: Xience group<br> | Device: Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA)<br>* Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; Xience Prime® vs. Cypher SelectTM and pravastatin 20mg vs. atorvastatin 40mg.<br>|
| Active Comparator: Pravastatin group<br> | Drug: Pravastatin 20mg<br>* 2x2 randomization by the treatment of dyslipidemia (In patients of dyslipidemia: pravastatin 20mg/day vs. atorvastatin 40mg and the types of the implanted cypher vs xience.<br>|
| Experimental: Atorvastatin group<br> | Drug: Atorvastatin 40mg<br>* 2x2 randomization by the treatment of dyslipidemia (In patients of dyslipidemia: pravastatin 20mg/day vs. atorvastatin 40mg and the types of the implanted cypher vs xience.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neointimal coverage according to the implanted DES; Xience vs. Cypher | Neointimal coverage means percentage of uncovered struts on OCT. The percentages of uncovered struts were compared between EES and SES. | up to 12month after stent implantation |