Serial EValuation of multiplE Coronary Artery Diseases by an Optical Coherence Tomography; Assessment of the Changes of de Novo Lesions and Comparisons of Neointimal Coverage Between Xience Prime® Versus Cypher SelectTM Stents; SEVEN-Xience Study

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Multi-vessel Diseases, Angina

Treatments: Drug: Atorvastatin 40mg; Drug: Pravastatin 20mg; Device: Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA); Device: Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL)

Study type: Interventional

Funder types: Other

Identifiers

NCT01856374

1-2010-0052

Details and patient eligibility

About

This study is a prospective open-labeled, randomized study to compare the neointimal coverage at 3 months and 12 months and its serial changes between 3 months and 12 months according to the implanted DES and evaluate the serial changes in the proximal portions of 3 epicardial coronary artery and left main artery including the assessment of fibrous cap thickness and lipid pool for vulnerable plaques by OCT. In addition, the investigators will compare the changes such as plaques and neointimal coverage from serial OCT follow-up according to the different statin strategy.

Enrollment: 60 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is ≥ 20 years old
• Patients with typical angina who are considered for coronary revascularization.
• Multi-vessel diseases: more than 2 significant coronary de novo lesions (> 70% by quantitative angiographic analysis); one of the target lesions is the most significant tight stenotic lesion causing the ischemic symptom and requiring the immediate revascularization but the others are significant but non-tight lesions to be delayed or observed for 3 months and not requiring immediate PCI for the complete revascularization of all coronary arteries.

Exclusion criteria

• ST-elevation MI
• Cardiogenic shock or hemodynamically unstable status
• Lesions requiring the immediate complete revascularization of all coronary stenotic lesions
• Contraindication to anti-platelet agents
• Treated with any DES within 6 months at other vessel
• Creatinine level ≥ 2.0 mg/dL or ESRD
• Severe hepatic dysfunction (3 times normal reference values)
• Pregnant women or women with potential childbearing
• Life expectancy 1 year
• Complex lesion morphologies (bifurcation lesions treated with 2-stent techniques, untreated significant unprotected left main diseases, chronic total occlusion, in-stent restenosis, and vein graft lesion)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Cypher group

Active Comparator group

Treatment:

Device: Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL)

Xience group

Experimental group

Treatment:

Device: Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA)

Pravastatin group

Active Comparator group

Treatment:

Drug: Pravastatin 20mg

Atorvastatin group

Experimental group

Treatment:

Drug: Atorvastatin 40mg