Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Stent
Brief summary
This randomized study is a multi-center, randomized, study to compare the efficacy of sirolimus (Cypher) versus zotarolimus-eluting stent (Endeavor Resolute) implantation for long coronary lesions.
Detailed description
Following angiography, patients with significant diameter stenosis \>50% and lesion length (\> 25mm) requiring single or multiple long-stent placement (total stent length\>28mm) by visual estimation and eligible for LONG-DES IV trial inclusion and exclusion criteria will be randomized 1:1 to a) CYPHER and b) ENDEAVOR RESOLUTE stent by the stratified randomization method.
Interventions
DEVICECypher
Sirolimus-eluting stent
DEVICEEndeavor Resolute
Zotarolimus-eluting Stent
Sponsors
CardioVascular Research Foundation, Korea
Medtronic
Seung-Jung Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must be at least 18 years of age. * Significant native coronary artery stenosis (\>50% by visual estimate) with lesion length of more than 25mm, which requiring single or multiple long stent placement (\>=28mm) * Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction * The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion criteria
* Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus. * An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment. * Acute ST-segment-elevation MI or cardiogenic shock * Terminal illness with life expectancy \<1 year * Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. * In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment, non-target vessel ISR is permitted) * Patients with EF\<30%. * Serum creatinine level \>=3.0mg/dL or dependence on dialysis. * Patients with left main stem stenosis (\>50% by visual estimate).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-segment late luminal loss | 9 month follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac death | 1 year | — |
| Myocardial infarction (MI) | 1 year | — |
| Composite of death or MI | 1 year | — |
| Composite of cardiac death or MI | 1 year | — |
| Target vessel revascularization (ischemia-driven and clinically-driven) | 1 year | — |
| Target lesion revascularization (ischemia-driven and clinically-driven) | 1 year | — |
| Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) | 12 months | — |
| All Death | 1 year | — |
| In-stent late loss at 9 month angiographic follow-up | at 9 month angiographic follow-up | — |
| In-stent and in-segment restenosis at 9 month angiographic follow-up | at 9 month angiographic follow-up | — |
| Angiographic pattern of restenosis at 9 month angiographic follow-up | at 9 month angiographic follow-up | — |
| Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study) | at 9 month angiographic follow-up | — |
| Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study) | at 9 month angiographic follow-up | — |
| Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay. | at 3 days in average | At discharge from the index hospitalization (normal hospitalization is from 3 -4 days.) |
| All death | one month | — |
| Stent thrombosis (ARC criteria) | 1 year | — |
Countries
South Korea
Outcome results
None listed