Japan-Drug Eluting Stents Evaluation; a Randomized Trial

Study Overview
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Brief Summary
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To evaluate the procedural, short and long term clinical outcomes of the TAXUS stent compared to Cypher stent in coronary arteries of ≥ 2.5 and ≤ 3.75 mm in the reference vessel diameter with a lesion of ≤ 46 mm (by visual observation) in routine clinical settings in Japan.

Detailed Description
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In these days, meta-analyses have been conducted in large scale and small scale studies, but there has been no conclusion yet stating which one of the stents, either Cypher stent or TAXUS stent, is superior to the other. In specific disease condition such as in diabetic patients, it has been reported that Paclitaxel (TAXUS stent) is more suitable than Sirolimus (Cypher stent), due to the difference in the action mechanisms of the drugs. Since TAXUS stent was recently approved in Japan, we decided to conduct a randomized multi-center comparative study to compare Cypher stent and TAXUS stent regarding the clinical endpoint (target vessel failure for 8 months). The study is powered to show equivalence between the 2 stents in all patients, and to show superiority of the TAXUS stent in the diabetic patient population. In addition, for selected patients, quantitative coronary angiography, intravascular ultrasound, optical coherence tomography, and angioscopy are performed to examine the difference of the two stents more closely.

Official Title
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A Japanese Prospective, Randomized, Multi-center Trial Comparing the TAXUS Stent and the CYPHER Stent in Patients With Coronary Artery Disease Eligible for PCI.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: TAXUS stent
* Device: Cypher stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥ 20 years old Patient suitable for percutaneous coronary intervention (PCI) Patient with signed informed consent Patient judged suitable to receive anti-platelet drugs (clopidogrel bisulfate or ticlopidine hydrochloride, etc.) in principle for at least 6 months after procedure, and ideally up to 12 months in patients who are not at high risk of bleeding, based on ACC/AHA guideline Patient with up to 3 lesions (with ≥ 50% of stenosis) in the maximum of 2 targeted vessels to be treated at once Patient with reference vessel diameter (RVD) of 2.5 mm to 3.75 mm by visual observation Patient with length of each lesion of up to 46 mm by visual assessment Patient eligible for implementation of drug eluting stent. Exclusion Criteria: Patient with any planned treatment in the targeted vessel with a drug eluting stent other than in this study Patient with acute myocardial infarction (AMI) (including non-ST segment elevation MI) developed within 7 days before the procedure Patient participating in a currently ongoing registry or clinical study, or receiving a treatment which may affect the endpoints of this study Patient of childbearing potential with a positive pregnancy test within 14 days before the procedure, or lactating Patient who has history of allergy against Sirolimus, Paclitaxel, polymers or stainless steel Patient who has history of side-effect against anti-platelet drugs or anti-coagulation drugs Patient with serious hepatic dysfunction Patient with left ventriculogram ejection fraction of 35% or less Patient with three target vessels in need of PCI treatment Patient with serious renal dysfunction (serum creatinine value 2mg/dL or higher) Patient currently receiving artificial dialysis Patient with a malignant tumor (cancer) diagnosed within 5 years before the procedure Patient who has received PCI treatment within the past one year Patient with chronic total occlusion (CTO) or TIMI flow 2 or less Patient with >50% stenosis in left main coronary artery Patient with >50% stenosis in side branch ostial for which stenting in the side branch lesion is required (KBT for side branch is accepted) Patient with in-stent restenosis in the target lesion implanted with a bare-metal or drug eluting stent Patient who has target lesion in saphenous vein graft Patient judged non-eligible by the physician in charge.

Ages Eligible for Study
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Minimum Age: 20 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 |
| --- | --- |
| Active Comparator: TAXUS group<br> | Device: TAXUS stent<br>* Compared two kinds of stents:TAXUS stent, approved for commercialization in Japan(March 30th, 2007)<br>|
| Active Comparator: Cypher group<br> | Device: Cypher stent<br>* CYPHER stent, approved for commercialization in Japan(March 25, 2004)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Vessel Failure (TVF) at 8 months post-procedure(assessed prior to routine angiography) in Overall study population |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Vessel Failure (TVF) at 8 months post-procedure (assessed prior to routine angiography) in diabetic group |  | 8 months |