Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension
Conditions
Keywords
SES vs BES
Brief summary
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.
Interventions
DEVICESirolimus-eluting stent
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.
DEVICEBiolimus-eluting stents
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.
DRUGpravastatin 20mg/day after DES implantation
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.
DRUGpitavastatin 2mg/day after DES implantation
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.
DRUGNon-ARB /day after DES implantation
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.
DRUGEposartan 600mg/day after DES implantation
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 20 year old 2. In the case that the blood pressure at rest is greater than systolic 140mmHg or more than diastolic 90mmHg 3. When someone is taking Anti-Hypertensive medication 4. If total cholesterol is more than 200mg/dL and LDL-cholesterol is greater than 130mg/dL or if you are taking a statin 5. Significant coronary de novo lesion (\> 70% by quantitative angiographic analysis) 6. Patients with stable angina or acute coronary syndrome considered for percutaneous coronary intervention. 7. Reference vessel diameter of 2.5 to 3.5 mm by operator assessment 8. Stent size of 2.5 to 3.5 mm and stent length ≤ 24 mm
Exclusion criteria
1. Contraindication to anti-platelet agents 2. Proximal leison within 15 mm from ostium 3. Creatinine level 2.0 mg/dL or end stage renal disease on dialysis 4. Pregnant women or women with potential childbearing 5. Life expectancy less than 1 year 6. Complex lesion morphologies (aorto-ostial, bifurcation with \>2.0 mm side branch, unprotected Left main, thrombus, severe calcification, chronic total occlusion) 7. Vein graft lesion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| neointimal coverage | 6month | 1. 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. 2. To compare the neointimal coverage on 6-month follow-up OCT according to the randomly assigned BES or SES implantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| stent malapposition and thrombus | 6month | 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. |
Countries
South Korea
Outcome results
None listed