The purpose of this study is to evaluate the relative effectiveness and safety of Bioresorbable Vascular Scaffold in acute myocardial infarction compared to other (drug eluting stents) DES.
Study Type
OBSERVATIONAL
Enrollment
69
Asan Medical Center
Seoul, South Korea
Composite event
The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)
Time frame: 1year
All death
Time frame: 5years
Cardiac death
Time frame: 5years
Myocardial infarction
Time frame: 5years
Composite event of death or myocardial infarction
Time frame: 5years
Composite event of cardiac death or myocardial infarction
Time frame: 5years
Target Vessel revascularization
Defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. Clinical-driven Clinically indicated angiography at follow-up shows a percent diameter stenosis ≥ 50% (core lab QCA assessment) and if one of the following occurs: (1) a positive history of recurrent angina pectoris, presumably related to the target vessel; (2) objective signs of ischemia at rest (ECG changes) of during exercise test (or equivalent), presumably related to the target vessel; (3) abnormal results of any invasive functional diagnostic test (eg, Doppler flow velocity reserve, fractional flow reserve). Ischemia-driven if one of followings of above-mentioned symptom (clinical-driven) or sign of ischemia or diameter stenosis ≥ 70 %
Time frame: 5years
Target Lesion revascularization
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Defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLRs should be classified prospectively as clinically indicated or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
Time frame: 5years
Stent thrombosis
DEFINITE stent thrombosis : acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE stent thrombosis : unexplained death within 30 days or target-vessel infarction without angiographic information Academic Research Consortium (ARC) stent thrombosis is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute stent thrombosis: 0-24 hours after stent implantation; Subacute stent thrombosis: \>24 hours to 30 days post; late stent thrombosis: \>30 days to 1 year post; Very late stent thrombosis: \>1 year post;
Time frame: 5years
Stroke
Time frame: 5years
Procedural success
Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death
Time frame: 3days