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 (MECHANISM-AMI)

Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent and Platelet AggregatioN studIeS for TreatMent of Acute Myocardial Infarction: MECHANISM-AMI

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: cobalt-chromium everolimus-eluting stent (CoCr-EES)

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Japan
  • Morioka, Japan, 020-8505
    • Iwate Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CoCr-EES, 2-week OCT follow-up; Undergo primary PCI with cobalt-chromium everolimus-eluting stent (CoCr-EES) for AMI culprit lesion and perform OCT observation at 2-week after PCI.	Device: cobalt-chromium everolimus-eluting stent (CoCr-EES); Other Names: XIENCE PRIME; XIENCE Xpedition
CoCr-EES, 3-month OCT follow-up; Undergo primary PCI with cobalt-chromium everolimus-eluting stent (CoCr-EES) for AMI culprit lesion and perform OCT observation at 3-month after PCI.	Device: cobalt-chromium everolimus-eluting stent (CoCr-EES); Other Names: XIENCE PRIME; XIENCE Xpedition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet Aggregation Test	(1) at the time of PCI, (2) at the time of OCT at 2 weeks or 3 months after PCI, (3) at 12-month follow-up, and (4) at the time of occurrence of a cardio-cerebrovascular event.	At the time of OCT follow-up (2 weeks or 3 months) and 12 month s

Collaborators and Investigators

• Sponsor: Iwate Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2014
• Primary Completion (Actual): September 25, 2015
• Study Completion (Actual): July 26, 2016

Study Registration Dates

• First Submitted: December 12, 2013
• First Submitted That Met QC Criteria: December 12, 2013
• First Posted (Estimate): December 18, 2013

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 17, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: STEMI; AMI; ACS
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Trace Elements; Micronutrients; Everolimus; Chromium; Cobalt
• Other Study ID Numbers: MECHANISM-AMI