Neointimal Coverage After Implantation of Biolimus Eluting Stent With Biodegradable Polymer: Optical Coherence Tomographic Assessment According to the Treatment of Dyslipidemia and Hypertension and the Types of Implanted Drug-eluting Stents

Study Overview
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Brief Summary
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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.

Conditions
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Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension

Intervention / Treatment
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* Device: Sirolimus-eluting stent
* Device: Biolimus-eluting stents
* Drug: pravastatin 20mg/day after DES implantation
* Drug: pitavastatin 2mg/day after DES implantation
* Drug: Non-ARB /day after DES implantation
* Drug: Eposartan 600mg/day after DES implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 20 year old In the case that the blood pressure at rest is greater than systolic 140mmHg or more than diastolic 90mmHg When someone is taking Anti-Hypertensive medication If total cholesterol is more than 200mg/dL and LDL-cholesterol is greater than 130mg/dL or if you are taking a statin Significant coronary de novo lesion (> 70% by quantitative angiographic analysis) Patients with stable angina or acute coronary syndrome considered for percutaneous coronary intervention. Reference vessel diameter of 2.5 to 3.5 mm by operator assessment Stent size of 2.5 to 3.5 mm and stent length ≤ 24 mm Exclusion Criteria: Contraindication to anti-platelet agents Proximal leison within 15 mm from ostium Creatinine level 2.0 mg/dL or end stage renal disease on dialysis Pregnant women or women with potential childbearing Life expectancy less than 1 year Complex lesion morphologies (aorto-ostial, bifurcation with >2.0 mm side branch, unprotected Left main, thrombus, severe calcification, chronic total occlusion) Vein graft lesion

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cypher group<br> | Device: Sirolimus-eluting stent<br>* 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.<br>|
| Experimental: Nobori group<br> | Device: Biolimus-eluting stents<br>* 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.<br>|
| Active Comparator: Pravastatin group<br> | Drug: pravastatin 20mg/day after DES implantation<br>* 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.<br>|
| Active Comparator: Pitivastatin group<br> | Drug: pitavastatin 2mg/day after DES implantation<br>* 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.<br>|
| Active Comparator: Non-ARB group<br> | Drug: Non-ARB /day after DES implantation<br>* 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.<br>|
| Experimental: ARB group<br> | Drug: Eposartan 600mg/day after DES implantation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neointimal coverage | To compare the neointimal coverage on 6-month follow-up OCT according to specific drug treatment in 2 patient subgroups at 6-month after DES implantation. To compare the neointimal coverage on 6-month follow-up OCT according to the randomly assigned BES or SES implantation. | 6month | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SES vs BES