Efficacy Study of Drug-eluting and Bare Metal Stents in Bypass Graft Lesions

Study Overview
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Brief Summary
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The aim of this study is to compare the efficacy of drug-eluting stents and bare metal stents to reduce reblockage of bypass grafts after coronary stenting

Detailed Description
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A large number of studies showed that drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare metal stents. Although this applies to the vast majority of patients, intimal hyperplasia and in-stent restenosis have not been completely eliminated and remain to occur in certain high risk subgroups. While there is a plenty of data about the efficacy of DES in complex lesions or diabetics, no randomized data exist about the efficacy of DES in coronary artery bypass graft lesions.

Official Title
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Prospective, Randomized Trial of Drug-eluting Stents vs. Bare Metal Stents for the Reduction of Restenosis in Bypass Grafts.

Conditions
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Arteriosclerosis of Arterial Coronary Artery Bypass Graft

Intervention / Treatment
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* Device: sirolimus-eluting stent
* Device: paclitaxel-eluting stent
* Device: biodegradable-polymer-based sirolimus-eluting stent
* Device: bare metal stents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in CABG Written, informed consent by the patient or her/his legally-authorized representative for participation in the study. In women with childbearing potential a negative pregnancy test is mandatory Exclusion Criteria: Cardiogenic shock Target lesion located in the native coronary vessels. In-stent restenosis of CABG Target lesion located at internal mammary artery graft or free arterial graft Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance. Known allergy to the study medications: clopidogrel, rapamycin, paclitaxel, stainless steel. Inability to take clopidogrel for at least 6 months. Pregnancy (present, suspected or planned) or positive pregnancy test. Previous enrollment in this trial. Patient's inability to fully cooperate with the study protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DES<br>drug-eluting stents | Device: sirolimus-eluting stent<br>* due to randomization Cypher stent will be implanted<br>* Other names: Cypher;Device: paclitaxel-eluting stent<br>* due to randomization Taxus stent will be implanted<br>* Other names: Taxus;Device: biodegradable-polymer-based sirolimus-eluting stent<br>* due to randomization a rapamycin-eluting stent with biodegradable polymer will be implanted<br>* Other names: ISAR-DES, Yukon PC;|
| Active Comparator: BMS<br>bare metal stents | Device: bare metal stents<br>* Due to randomization one bare-metal stent will be implanted. The decision about the stent type will be up to the interventionalist<br>* Other names: etc.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point of the study is composite of death, myocardial infarction and target lesion revascularization at one year after stent implantation |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarction rate |  | 12 months | 
| Need of target lesion revascularization (TLR), defined as any revascularization procedure involving the target lesion due to luminal re-narrowing in the presence of symptoms or objective signs of ischemia. |  | 12 months | 
| All cause death |  | 12 months | 
| Stent thrombosis |  | 12 months |