Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Arterial Occlusive Diseases, Arteriosclerosis, Cardiovascular Diseases, Heart Diseases, Vascular Diseases
Conditions
Keywords
optical coherence tomography, everolimus-eluting stent, zotarolimus-eluting stent
Brief summary
The purpose of this study is to evaluate the incidence of late incomplete stent apposition (ISA) and un-coverage by optical coherence tomography (OCT) following everolimus-eluting stent (EES) with bioabsorbable polymer (SYNERGY™, Boston Scientific,Nattick, MA, USA) versus zotarolimus-eluting stent (ZES) with permanent polymer(Resolute Onyx™, Medtronic, Santa Rosa, CA, USA) implantation in patients with AMI at 12 months.
Detailed description
It has been known that persistence of polymer may affect the late/very late safety and efficacy of drug eluting stent (DES) although polymer provides a reservoir for programmed drug release. Newer durable polymers may have enhanced biocompatibility and seem to be associated with improved clinical outcomes. However, they have still been incriminated in the occurrence of inflammation, neo-atherosclerosis, and thrombosis. Therefore, the investigators will evaluate the vascular tissue reaction after different kinds of DES implantation under the high thrombogenic circumstance of acute myocardial infarction (AMI).
Interventions
DEVICEEverolimus-Eluting stent
Everolimus-Eluting stent with bioabsorbable polymer
Zotarolimus-Eluting stent with permanent polymer
Sponsors
Keimyung University Dongsan Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute myocardial infarction including ST-segment elevation myocardial infarction (STEMI) or non ST-segment elevation myocardial infarction (NSTEMI) treated with PCI * Patient ≥ 18 years of age * Patient judged suitable to receive anti-platelet drugs of ASA and ticagrelor for at least 12 months after the procedure * The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic, OCT follow up and provides informed consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site. * culprit lesion
Exclusion criteria
* The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, abciximab, aspirin, ticagrelor, everolimus, zotarolimus, polymer, platinum chromium, cobalt chromium, contrast media * Female of childbearing potential unless a pregnancy test is negative or who possibly plan to become pregnant any time after enrollment * Cardiogenic shock * Patient with left ventricular ejection fraction \<30% * Patient with left main disease * Patient with In-stent restenosis (ISR) at target vessel (either bare metal stent or DES, non-target vessel ISR is permitted) * Patient with impaired renal function (creatinine \>2.0mg/dL) * Patient with inadequate OCT images quality due to severe calcification, vessel tortuosity and artifacts * bifucation lesion needs complex procedure with insert two or more Drug eluting stents. * lesion length \>30mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of malapposed and uncovered stent strut at 12±1 months in both DES groups | 12month | Incidence of malapposed and uncovered stent strut measured by OCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent neointima cross-sectional area | 12month | By OCT, percentage neointima cross sectional area can be obtained by dividing the neointimal area by the stent area.(neointima cross-sectional area in mm²(Quadratmillimeter)/sec) |
| Mean neointima thickness | 12month | By OCT, neointima thickness can be measured as distance from the endoluminal surface of the neointima to the stent strut.(mean neointima thickness in millimeter) |
| Morphologic characteristics of neointima | 12month | Morphologic characteristics of neointima measured by OCT(morphologic characteristics of neointima is one of fibrous, fibrocalcific, lipid-laden) |
Countries
South Korea
Outcome results
None listed