Study to Test the Efficacy and Safety of Drug Eluting vs. Bare-Metal Stents for Saphenous Vein Graft Interventions

Study Overview
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Brief Summary
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Prospective multicenter controlled randomized trial to compare the safety and efficacy of drug eluting vs. bare metal stents in percutaneous coronary interventions of saphenous vein grafts. Hypothesis: Survival and outcome will be significantly better in patients receiving DES than in patients receiving BMS regarding both short-term and long-term outcome.

Detailed Description
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Research Question: What is the effect of the paclitaxel eluting TAXUS® Liberté® stent compared with the bare-metal Liberté® stent (both Boston Scientific Corporation, Natick, MA) in saphenous vein graft (SVG) percutaneous coronary interventions (PCI) when used in conjunction with a glycoprotein IIb/IIIa inhibitor, e.g., abciximab (ReoPro®, Eli Lilly & Co., Indianapolis, IN), and a distal filter system? Design: Prospective, multicenter, controlled randomized trial. Subjects: Inclusion criteria: Patients undergoing SVG PCI with a target vessel reference diameter ≤ 5.5 mm (visual estimate); documented silent ischemia, stable angina pectoris Canadian Cardiovascular Society (CCS) class I to IV, or acute coronary syndrome. Exclusion criteria: Previous stent implantation anywhere in the target SVG; concomitant native vessel PCI; SVG age <6 months; arterial grafts; oral anticoagulation; platelet count <100x109/L or >700x109/L; any major non-cardiac condition with a life expectancy <12 months; known allergies against the components tested; white blood cell count <3000 cell/mm3; enrolled in other study; no consent; patients unlikely to comply to the study treatment and the follow-up visits. Recruitment: Consecutive sample of all patients who qualify Variables: Predictor: Randomization will be single-blinded 1:1 to the TAXUS® Liberté® vs. the Liberté® stent (both Boston Scientific Corporation, Natick, MA). In all patients, a distal filter system will be used during PCI. The use of a glycoprotein IIb/IIIa inhibitor, e.g., abciximab (ReoPro®, Eli Lilly & Co., Indianapolis, IN), will be strongly recommended (bolus prior to PCI and 12 h infusion post PCI). Outcome: Primary: MACE after 12 months. MACE will be defined as the composite of cardiac death (all deaths not clearly non-cardiac), non-fatal myocardial infarction, and TVR. Secondary: Non-fatal myocardial infarction and cardiac death at 30 days and 6, 12, 36, and 60 months; MACE at 30 days and 6, 36, and 60 months; quality of life; individual components of the primary endpoint; non-cardiac death; major bleeding, defined as need for surgery, need for blood transfusions, and cerebral hemorrhage during antiplatelet therapy; minor bleeding, defined as a drop in hematocrit of >2 mg/dL.

Official Title
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BAsel Stent Kosten Effektivitäts Trial - SAphenous Venous Graft Angioplasty Using Glycoprotein IIb/IIIa Receptor Inhibitors and Drug-Eluting Stents

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Drug eluting stent
* Device: Bare metal stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing SVG PCI with a target vessel reference diameter ≤ 5.5 mm (visual estimate) Documented silent ischemia, stable angina pectoris Canadian Cardiovascular Society (CCS) class I to IV, or acute coronary syndrome Exclusion Criteria: Previous stent implantation anywhere in the target SVG Concomitant native vessel PCI SVG age <6 months Arterial grafts Oral anticoagulation Platelet count <100x109/L or >700x109/L, white blood cell count <3000 cells/mm3 Any major non-cardiac condition with a life expectancy <12 months Planned elective surgery in the next 12 months Known allergies against the components tested Enrolled in other study No consent Patients unlikely to comply to the study treatment and the follow-up visits Age <18 years Known pregnancy

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Percutaneous coronary intervention | Device: Drug eluting stent<br>* Implantation of stent<br>* Other names: TAXUS Liberté;|
| Placebo Comparator: 2<br>Percutaneous coronary intervention | Device: Bare metal stent<br>* Implantation of stent<br>* Other names: Liberté;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (composite of cardiac death, i.e., all deaths not clearly non-cardiac, non-fatal myocardial infarction, and TVR |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-fatal MI and cardiac death; MACE; QoL; individual components of the primary endpoint; non-cardiac death; major bleeding; minor bleeding |  | 30 days and 6, 12, 36, and 60 months |