To treat patients with acute myocardial infarction, primary percutaneous coronary intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated by optical coherence tomography (OCT) at 2 weeks or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OCT findings and the time course of platelet aggregation and between OCT findings and the occurrence of major cardio- cerebrovascular events will also be elucidated.
Study Type
OBSERVATIONAL
Enrollment
100
Iwate Medical University Hospital
Morioka, Japan
The percentage of stent strut coverage by OCT
To observe temporal course from the early stage, the rate of stent-strut coverage in the 3-months arm will also be evaluated in a complementary manner, separately from the 2-weeks arm.
Time frame: 2 weeks
All-cause Death, Cardiac death, Myocardial Infarction (MI), Stroke, Major bleeding
Time frame: 1 year
Any Target Lesion Revascularization (TLR)
Time frame: 1 year
Clinically-driven TLR
Time frame: 1 year
Any Target Vessel Revascularization (TVR)
Time frame: 1 year
Coronary-artery bypass surgery (CABG)
Time frame: 1 year
Any revascularization
Time frame: 1 year
Angiographic binary restenosis
Time frame: 1 year
Patient-oriented composite
Composite of All-cause death, any MI including non-target territory, any repeat revascularization and Stroke
Time frame: 1 year
OCT Endpoint
* The percentage of stent strut malapposition * The presence of Intra-stent thrombus * Intra-stent thrombus area (Maximum site) * Intra-stent thrombus length * The number of Intra-stent thrombus
Time frame: 2 weeks and 3 months
Angiographic Quantitative analysis
* In-segment late loss * Minimal lumen diameter (MLD), reference vessel diameter (RVD), percent diameter stenosis (%DS) * In-stent late loss * Binary restenosis (In-stent, In-segment, Peri-stent) * Angiographically detected stent fracture(based on Popma's classification ) * The number of Intra-stent thrombus
Time frame: 12 month
Angiographic Qualitative analysis
* Peri-stent contrast stain (PSS) * Site and pattern of restenosis (based on Mehran classification)
Time frame: 12 month
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