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There has been little research on neointimal coverage and malapposition after BES implantation using OCT in human coronary artery. Furthermore, specific drug may possibly influence the vascular healing after stent implantation. Therefore, this study will investigate 1) neointimal coverage and malapposition on OCT after BES versus SES implantation and 2) relationship of specific drug treatment and neointimal coverage or late malapposition by the prospective, randomized study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cypher group | Active Comparator |
| |
| Nobori group | Experimental |
| |
| Pravastatin group | Active Comparator |
| |
| Pitivastatin group | Active Comparator |
| |
| Non-ARB group | Active Comparator |
| |
| ARB group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus-eluting stent | Device | 2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES. |
| Measure | Description | Time Frame |
|---|---|---|
| neointimal coverage |
| 6month |
| Measure | Description | Time Frame |
|---|---|---|
| stent malapposition and thrombus | The secondary endpoint of this study is to compare percent of stent malapposition and thrombus at 6 months according to specific drug treatment in 2 patient subgroups or to the types of implanted DES, SES vs. BES by a 6-month follow-up OCT. | 6month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myeong Ki Hong, Ph.D | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24835329 | Derived | Kim JS, Ha J, Kim BK, Shin DH, Ko YG, Choi D, Jang Y, Hong MK. The relationship between post-stent strut apposition and follow-up strut coverage assessed by a contour plot optical coherence tomography analysis. JACC Cardiovasc Interv. 2014 Jun;7(6):641-51. doi: 10.1016/j.jcin.2013.12.205. Epub 2014 May 14. | |
| 24531309 | Derived |
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|
| Biolimus-eluting stents | Device | 2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES. |
|
| pravastatin 20mg/day after DES implantation | Drug | 2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES. |
|
| pitavastatin 2mg/day after DES implantation | Drug | 2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES. |
|
| Non-ARB /day after DES implantation | Drug | 2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES. |
|
| Eposartan 600mg/day after DES implantation | Drug | 2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES. |
|
| Kim BK, Ha J, Mintz GS, Kim JS, Shin DH, Ko YG, Choi D, Jang Y, Hong MK. Randomised comparison of strut coverage between Nobori biolimus-eluting and sirolimus-eluting stents: an optical coherence tomography analysis. EuroIntervention. 2014;9(12):1389-97. doi: 10.4244/EIJV9I12A236. |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| 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 |
| C108475 | pitavastatin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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