Nonpolymer- and Polymer-Based Drug-Eluting Stents for Restenosis (ISAR-TEST-1)

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of nonpolymer-based rapamycin-eluting stent compared to standard polymer-based paclitaxel-eluting stent to reduce reblockage of coronary arteries.

Detailed Description
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Drug-eluting stents represent a major advance in the treatment of restenosis. They have dramatically reduced the need of repeat revascularization procedures, and, thanks to the excellent results obtained in various patient subsets, these devices are now used in almost 90% of the stent implantation procedures performed in US hospitals. Along with the increasing number of patients receiving drug-eluting stents and availability of long-term follow-up data, concern has arisen regarding the safety of these devices. At the core of this concern is the potential for increased inflammatory and thrombogenic responses and their life-threatening consequences associated with the polymers employed for the delivery of antirestenotic agents. A growing interest has been shown on polymer-free stents with a microporous surface as an alternative to stents employing polymeric coating for local drug delivery. Recently, we developed a mobile system which enables coating in the catheterization laboratory of polymeric free stents with different drug doses or combinations. Using a porcine coronary model of restenosis, we found that coating with rapamycin of a polymer-free microporous stent is feasible and effectively reduces neointimal proliferation. More recently, in a clinical study in which the efficacy of several doses of rapamycin was assessed, we showed that non-polymer coating with rapamycin is safe and leads to a dose-dependent reduction in restenosis. While the advantage deriving from the lack of polymeric cover in on-site coated rapamycin-eluting stents is readily understandable, their relative efficacy as compared with commercially available polymer-based drug-eluting stents has yet to be evaluated. Comparison: Polymer-free microporous stents coated with rapamycin versus standard polymer-based, paclitaxel-eluting stents

Official Title
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A Randomized Trial of a Nonpolymer-Based Rapamycin-Eluting Stent Versus a Polymer-Based Paclitaxel-Eluting Stent for the Prevention of Restenosis (ISAR-TEST-1)

Conditions
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Coronary Disease

Intervention / Treatment
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* Device: Paclitaxel-eluting stent (Taxus)
* Device: Rapamycin-eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at least 18 years old Stable or unstable angina or a positive stress test de novo coronary artery lesions Written informed consent Exclusion Criteria: Myocardial infarction within 48 h. before enrollment Target lesion located in left main trunk Contraindication or known allergy to aspirin, heparin, thienopyridines, rapamycin, paclitaxel or stainless steel

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: 1<br>Due to randomisation patients got a Paclitaxel-eluting stent | Device: Paclitaxel-eluting stent (Taxus)<br>* patients has been implanted the Paclitaxel-eluting stent.<br>* Other names: Taxus;|
| Experimental: 2<br>Due to randomization patients got a Rapamycin-eluting stent. | Device: Rapamycin-eluting stent<br>* patients has been implanted the Rapamycin-eluting stent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent late luminal loss |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic restenosis at follow-up angiography |  | 6 months | 
| Need for target lesion revascularization due restenosis at 9 months |  | 9 months |