Acute Myocardial Infarction
Conditions
Keywords
Acute Myocardial Infarction, Percutaneous Coronary Interventions, Optical Coherence Tomography, Thrombus
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.
Interventions
DEVICEENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)
ENDEAVOR® drug-eluting stent implanted in acute myocardial infarction
DEVICEDRIVER bare metal stent (Medtronic, Santa Rosa, Ca)
DRIVER bare metal stent implanted in acute myocardial infarction
Comparison of Drug Eluting versus Bare Metal Stent
Comaprison between Drug Eluting and Bare Metal Coronary Stents
Sponsors
Case Western Reserve University
Medtronic
A.O. Ospedale Papa Giovanni XXIII
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \[≥ 3.75 mm in diameter\])
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent | 6 months | Non inferiority |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of well apposed stent struts without neointima | 6 months | number of well apposed stent struts without neointima |
| number of malapposed stent struts without neointima | 6 months | number of malapposed stent struts without neointima |
| Number of sections with incomplete strut apposition | 6 months | Number of sections with incomplete strut apposition |
| Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority) | 6 months | Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority) |
| In segment OCT neontimal volume | 6 months | In segment OCT neontimal volume |
| number of sections with > 30% uncovered struts/total struts | 6 months | number of sections with \> 30% uncovered struts/total struts |
Countries
Italy
Outcome results
None listed