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

Yonsei University120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

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

Interventions

Biolimus-eluting stentsDEVICE

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 implantationDRUG

pitavastatin 2mg/day after DES implantationDRUG

Non-ARB /day after DES implantationDRUG

Eposartan 600mg/day after DES implantationDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

neointimal coverage

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.

Time frame: 6month

Secondary Outcomes

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.