The primary purpose of this study is to determine whether PCI added to OMT could be superior over OMT alone in the prevention of late adverse cardiac and cerebro-vascular events in elderly patients with coronary artery disease (CAD) during the additional 12 months.
Study Design * Prospective, randomized, multi-center study of each 1600 subjects enrolled. * Eligible subjects will be randomized 1:1 to a) PCI added to OMT (n=800) vs. b) OMT alone(n=800). Subsequently, subjects in PCI added to OMT group will be randomly assigned to everolimus eluting stent(n=400) vs. zotarolimus eluting sten(n=400). All subjects will be followed for 1 year after randomization. Additional long-term follow-up (2- or 3-year) will be preceded in the next plan after 1-year study period. * Subjects with CAD who meet all inclusion and exclusion criteria will be included * Clinical and laboratory follow-up should be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,600
Everolimus Eluting Stent(Xience V, Xience prime) Zotalolimus Eluting Stent(Endeavor-resolute, Resolute Integrity)
one or two anti-platelet agents, beta-blockers, calcium channel blockers, nitrates, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and statin
Myeong-Ki, Hong
Seoul, South Korea
RECRUITINGMajor Adverse Cardiac Event
The primary end-point is the occurrence of major adverse cardiac event \[cardiovascular death, non-fatal MI (excluding periprocedural MI), stroke or any revascularization (PCI or coronary bypass surgery \[CABG\]) for 12 months following the randomization to the assigned management\]
Time frame: 12month
cardiac or non-cardiac major adverse event
1. The composite of cardiac or non-cardiac death, non-fatal MI, stent thrombosis (ST), target vessel revascularization (TVR) (either by PCI or CABG), non-TVR, hospitalization for unstable angina pectoris (UAP) or congestive heart failure (CHF), and cerebrovascular accident (CVA) for 12 months. 2. Major determinant for the occurrence of major events 3. Sub-study according to the subsets of disease 4. Association between parameters at index procedure and clinical outcomes
Time frame: 12month
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