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

NCT01856374 | Completed Phase 4

• 1 other identifier: 1-2010-0052
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multi-vessel Diseases, Angina

Outcome Measures

Primary Outcomes (1)

• neointimal coverage according to the implanted DES; Xience vs. Cypher

  Neointimal coverage means percentage of uncovered struts on OCT. The percentages of uncovered struts were compared between EES and SES.

  up to 12month after stent implantation

Study Arms (4)

Cypher group

ACTIVE COMPARATOR

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

Xience group

EXPERIMENTAL

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

Pravastatin group

ACTIVE COMPARATOR

Drug: Pravastatin 20mg

Atorvastatin group

EXPERIMENTAL

Drug: Atorvastatin 40mg

Interventions

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

Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; Xience Prime® vs. Cypher SelectTM and pravastatin 20mg vs. atorvastatin 40mg.

Cypher group

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

Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; Xience Prime® vs. Cypher SelectTM and pravastatin 20mg vs. atorvastatin 40mg.

Xience group

Pravastatin 20mg DRUG

2x2 randomization by the treatment of dyslipidemia (In patients of dyslipidemia: pravastatin 20mg/day vs. atorvastatin 40mg and the types of the implanted cypher vs xience.

Pravastatin group

Atorvastatin 40mg DRUG

2x2 randomization by the treatment of dyslipidemia (In patients of dyslipidemia: pravastatin 20mg/day vs. atorvastatin 40mg and the types of the implanted cypher vs xience.

Atorvastatin group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

• Kim JS, Kim JH, Shin DH, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. Effect of High-Dose Statin Therapy on Drug-Eluting Stent Strut Coverage. Arterioscler Thromb Vasc Biol. 2015 Nov;35(11):2460-7. doi: 10.1161/ATVBAHA.115.306037. Epub 2015 Sep 10.

  PMID: 26359512 DERIVED

MeSH Terms

Conditions

Angina Pectoris

Interventions

Pravastatin; Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 17, 2013
• Study Start: August 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 27, 2016

Record last verified: 2016-07

Locations

KR (1)