The purpose of this study is to determine whether ABSORB bioresorbable vascular scaffold is non-inferior to XIENCE everolimus-eluting cobalt-chromium stent with respect to target-lesion failure (TLF) at 1 year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
800
Asan Medical Center
Seoul, South Korea
Target lesion failure
event rate for composite of cardiac death, target-vessel myocardial infarction \[MI\], or ischemia-driven target-lesion revascularization
Time frame: 1 year
Cardiac death
Time frame: 5 years
Target-vessel myocardial infarction
Time frame: 5 years
Ischemia-driven target-lesion revascularization
Time frame: 5 years
All-cause mortality
Time frame: 5 years
event rate of any myocardial infarction; Q-wave vs Non-Q wave, periprocedural myocardial infarction vs follow-up myocardial infarction
Time frame: 5 years
Any revascularization
Any revascularization; target lesion vs. nontarget lesion, target vessel vs. nontarget vessel, ischemia-driven vs. not ischemia-driven
Time frame: 5 years
Target-vessel failure
death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization
Time frame: 5 years
Stent thrombosis
Time frame: 5 years
event rate of device success or procedural success
Device success defined as angiographic evidence of \<30% final residual stenosis of the target lesion. Procedural success is defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death.
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Time frame: 5 years
Patient-reported angina status measured by Seattle angina questionnaire
Time frame: 5 years