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 University

Status and phase: Completed; Phase 4

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01502904

1-2010-0007

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 6 patient groups

Cypher group

Active Comparator group

Treatment:

Device: Sirolimus-eluting stent

Nobori group

Experimental group

Treatment:

Device: Biolimus-eluting stents

Pravastatin group

Active Comparator group

Treatment:

Drug: pravastatin 20mg/day after DES implantation

Pitivastatin group

Active Comparator group

Treatment:

Drug: pitavastatin 2mg/day after DES implantation

Non-ARB group

Active Comparator group

Treatment:

Drug: Non-ARB /day after DES implantation

ARB group

Experimental group

Treatment:

Drug: Eposartan 600mg/day after DES implantation