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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cypher group | Active Comparator |
| |
| Xience group | Experimental |
| |
| Pravastatin group | Active Comparator |
| |
| Atorvastatin group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL) | Device | Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; Xience PrimeĀ® vs. Cypher SelectTM and pravastatin 20mg vs. atorvastatin 40mg. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26359512 | Derived | Kim JS, Kim JH, Shin DH, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. Effect of High-Dose Statin Therapy on Drug-Eluting Stent Strut Coverage. Arterioscler Thromb Vasc Biol. 2015 Nov;35(11):2460-7. doi: 10.1161/ATVBAHA.115.306037. Epub 2015 Sep 10. |
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| Everolimus-eluting stent(Xience PrimeĀ®, Abbott Vascular, Santa Claea, CA) | Device | Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; Xience PrimeĀ® vs. Cypher SelectTM and pravastatin 20mg vs. atorvastatin 40mg. |
|
| Pravastatin 20mg | Drug | 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. |
|
| Atorvastatin 40mg | Drug | 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. |
|
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017035 | Pravastatin |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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