Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent and Platelet AggregatioN studIeS for TreatMent of Acute Myocardial InfarctionTreatment of ST-elevation Acute Myocardial Infarction

Completed

Conditions: Coronary Artery Disease

Interventions: Device: cobalt-chromium everolimus-eluting stent (CoCr-EES)

Registration Number: NCT02014753

Lead Sponsor: Iwate Medical University

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

Inclusion Criteria

AMI definition is accordance with the third universal definition of ESC /ACCF/ AHA/ WHF Task Force10, detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn) I or T] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: Symptoms of ischemia. New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundlebranch block (LBBB).

Development of pathological Q waves in the ECG. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

Identification of an intracoronary thrombus by angiography or autopsy Of the AMI patients who met the above definition, the criterial for inclusion is limited to STEMI patients. STEMI is defined as new ST elevation at the J point in at least 2 contiguous leads of equal or greater than2 mm (0.2 mV) in men equal or greater than1.5 mm (0.15 mV) in women in leads V2-V3 and/or of equal or greater than 1 mm (0.1 mV) in other contiguous chest leads or the limb leads

Patients having at least one de novo lesion in a coronary artery in whom PCI with a DES is indicated.
Patients aged 20 to less than 85 years at the time of informed consent
Patients who have provided informed consent written by themselves
Patients who are able to undergo OCT examinations of the site of stent placement at 2 weeks or 3 months and at 12 months.

Exclusion Criteria

Shock
Patients who are judged incapable of undergoing clinical follow-up 12 months after PCI (Consider also the location of patients' residences)
Lack of specific findings of ACS by angiography (Left to the operator's decision.)
The culprit lesion is the left main coronary trunk
Lesion with the reference vascular diameter less than 2.0mm or not less than 4.5mm by visual evaluation.
Chronic renal failure with serum creatinine level not less than 2.0mg/dl on hospital visit
Patients on hemodialysis Cancer patients whose vital prognosis is expected to be within 2 years. Surgery that requires discontinuation of the antiplatelet agent is scheduled within 3 months
Patients who experienced adverse reaction to aspirin or clopidogrel (this shall not apply for patients in whom safety of ticlopidine is confirmed)
Patients who took warfarin before the onset
Patients under 20 years old
Pregnant women
AMI due to stent thrombosis at prior stented segment.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CoCr-EES, 2-week OCT follow-up	cobalt-chromium everolimus-eluting stent (CoCr-EES)	Undergo primary PCI with cobalt-chromium everolimus-eluting stent (CoCr-EES) for AMI culprit lesion and perform OCT observation at 2-week after PCI.
CoCr-EES, 3-month OCT follow-up	cobalt-chromium everolimus-eluting stent (CoCr-EES)	Undergo primary PCI with cobalt-chromium everolimus-eluting stent (CoCr-EES) for AMI culprit lesion and perform OCT observation at 3-month after PCI.

Primary Outcome Measures

Name	Time	Method
The percentage of stent strut coverage by OCT	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Any Target Vessel Revascularization (TVR)	1 year
Any Target Lesion Revascularization (TLR)	1 year
Coronary-artery bypass surgery (CABG)	1 year
Angiographic binary restenosis	1 year
OCT Endpoint	2 weeks and 3 months	* 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
Clinically-driven TLR	1 year
Any revascularization	1 year
Angiographic Quantitative analysis	12 month	* 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
Angiographic Qualitative analysis	12 month	* Peri-stent contrast stain (PSS) * Site and pattern of restenosis (based on Mehran classification)
All-cause Death, Cardiac death, Myocardial Infarction (MI), Stroke, Major bleeding	1 year
Patient-oriented composite	1 year	Composite of All-cause death, any MI including non-target territory, any repeat revascularization and Stroke

Trial Locations

Locations (1): Iwate Medical University Hospital
🇯🇵
Morioka, Japan

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