Multi-vessel Diseases, Angina
Conditions
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.
Interventions
DEVICESirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL)
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.
DEVICEEverolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA)
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.
DRUGPravastatin 20mg
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.
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| neointimal coverage according to the implanted DES; Xience vs. Cypher | up to 12month after stent implantation | Neointimal coverage means percentage of uncovered struts on OCT. The percentages of uncovered struts were compared between EES and SES. |
Countries
South Korea
Outcome results
None listed