Vessel Wall Response of the Zotarolimus Drug-eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neointima disomogeneities in texture) to the ENDEAVOR drug-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted for the treatment of the culprit lesion in ST-elevation acute myocardial infarction (STEMI). To investigate the completeness of the coverage as well as the number of uncovered stent struts per section (embedded, uncovered, malapposed) and the neointima texture, high resolution (  10-15 µm axial) intracoronary optical coherence tomography (OCT)will be used.

Detailed Description
-----------------
Major concerns have been raised with regard to the safety of drug-eluting stents (DES) in patients with ST-elevation acute myocardial infarction (STEMI). Data from registry studies have suggested that implantation of DES during primary PCI could be associated with an increased risk for stent thrombosis, probably due to delayed arterial healing. Unlike first generation DES, zotarolimus-eluting stents seems to be associated with complete and uniform neointimal coverage. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response to the ENDEAVOR zotarolimus-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted in STEMI patients. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at 6 months follow-up. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and at 6 months follow-up.

Official Title
-----------------
Prospective, Randomized, Controlled Arm Study Comparing the Coverage of the Zotarolimus-eluting Stent vs Bare Metal Stent Implanted in ST- Elevation Myocardial Infarction (STEMI).

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Device: ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)
* Device: DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)
* Device: Coronary stent implantation
* Device: Bare Metal Coronary Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Myocardial MI with ST segment Elevation, within 12 hours from symptoms onset Native coronary artery disease with >70% diameter stenosis (no prior stent implant, no prior brachytherapy) Vessel size in between 2.5 and 3.75 mm Signed patient informed consent Exclusion Criteria: Lesions in coronary artery bypass grafts Significant left main disease Killip class IV Reecent major bleeding (6 months) Renal failure with creatinine value > 2.5 mg/dl Allergy to aspirin and or clopidogrel/ticlopidine Patient in anticoagulant therapy IMA due to a stent thrombosis No suitable anatomy for OCT scan: (only ostial location, very tortuous anatomy, very distal or large vessels [≥ 3.75 mm in diameter])

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: DES - Zotarolimus Drug eluting stents<br>Zotarolimus Drug eluting stents in overlap | Device: ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)<br>* ENDEAVOR® drug-eluting stent implanted in acute myocardial infarction<br>Device: Coronary stent implantation<br>* Comparison of Drug Eluting versus Bare Metal Stent<br>* Other names: Zotarolimus Eluting Coronary Stent;|
| Active Comparator: BMS -Bare metal stent<br>Bare metal stent | Device: DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)<br>* DRIVER bare metal stent implanted in acute myocardial infarction<br>Device: Bare Metal Coronary Stent<br>* Comaprison between Drug Eluting and Bare Metal Coronary Stents<br>* Other names: Driver Coronary Stent;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent | Non inferiority | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of well apposed stent struts without neointima | number of well apposed stent struts without neointima | 6 months | 
| number of malapposed stent struts without neointima | number of malapposed stent struts without neointima | 6 months | 
| number of sections with > 30% uncovered struts/total struts | number of sections with > 30% uncovered struts/total struts | 6 months | 
| Number of sections with incomplete strut apposition | Number of sections with incomplete strut apposition | 6 months | 
| Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority) | Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority) | 6 months | 
| In segment OCT neontimal volume | In segment OCT neontimal volume | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Myocardial Infarction, Percutaneous Coronary Interventions, Optical Coherence Tomography, Thrombus