Outcome of Second Generation Drug-eLuting Stents in Patients With Diabetes Mellitus

Study Overview
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Brief Summary
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Design: prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of target lesion failure (TLF) of second generation paclitaxel- versus ABT578- versus Everolimus- eluting stents Study Population: all consecutive diabetic patients with de novo coronary artery lesions undergoing drug-eluting stent implantation in 2010-12. Time Course: initial Enrollment: October 2010; end of the Enrollment: December 2012 Primary End-Point: target lesion revascularization (TLF) defined as the occurrence of cardiac death, myocardial infarction and repeated lesion revascularization within 12 months. Secondary End-Points: 1) impact of glucose level during the first three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization; 2)TLF and TLR within 12, 24 and 36 months; 3) comparison 12 months versus prolonged (> 12 months) of dual antiplatelet therapy

Detailed Description
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Prospective, randomized, triple arm study. The study population will include all consecutive diabetic patients within 24 months undergoing elective second generation DES implantation for de novo coronary artery disease. In the randomization process all participating centers will be equally stratified to avoid statistical unbalance.

Official Title
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Outcome of seCond Generation Drug-ELuting Stents in Patients With Diabetes Mellitus: cOmparison of Three differenT Drug Regimens

Conditions
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Coronary Artery Disease, Diabetes Mellitus

Intervention / Treatment
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* Device: Taxus Element stent
* Device: Integrity Resolute stent
* Device: Xience Prime stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is > 18 years old Presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a second generation drug-eluting stent Subject and the treating physician agree that the subject will comply with all follow-up evaluations Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site Exclusion Criteria: Subject's age is < 18 years and with acute myocardial infarction in the 48 prior to the procedure The patient is pregnant or breastfeeding Known allergies to: aspirin, clopidogrel (Plavix) and ticlopidine (tiklid), heparin, Paclitaxel, Everolimus, ABT 578, stainless steel, or contrast agent (which cannot be adequately pre-medicated) A platelet count < 75,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3,000 cells/mm3 Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints Prior participation in this study Active peptic ulcer or upper GI bleeding within the prior 3 months Subject has active sepsis Any lesion that is located in a saphenous vein graft In the investigator's opinion, subject has a co-morbid condition(s) that could limit the life expectancy to less than one year, or limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study

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 |
| --- | --- |
| Active Comparator: Taxus Element<br>Patients treated with paclitaxel-eluting stent (Taxus Element, Boston Scientific, MN) | Device: Taxus Element stent<br>* paclitaxel-eluting stent<br>* Other names: Taxus;|
| Active Comparator: Xience Prime<br>Patients treated with Everolimus-eluting stent (Xience Prime, Abbott, IL) | Device: Xience Prime stent<br>* Everolimus-eluting stent<br>* Other names: Xience Prime;|
| Active Comparator: Integrity Resolute<br>Patients treated with ABT 578-eluting stent (Integrity Resolute, Medtronic, MA) | Device: Integrity Resolute stent<br>* ABT 578-eluting stent<br>* Other names: Resolute Integrity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure | Target lesion failure (TLF) defined as the occurrence of cardiac death, target vessel-related myocardial infarction and repeated revascularization of the target lesion | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of glucose levels on repeat revascularization | Impact of glucose level during the three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization rate | 1 year | 
| Target Lesion Revascularization | Target lesion revascularization at 12, 24 and 36 months | 1, 2 and 3 year | 
| Effect of dual antiplatelet therapy on outcome | Comparison of 12-month versus prolonged (> 12-month) dual antiplatelet therapy on outcome | 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, Drug-eluting Stent, Multicenter study