Coronary Artery Disease
Conditions
Keywords
Coronary artery disease 75years of age or older
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEverolimus Eluting Stent or Zotalolimus Eluting Stent
Everolimus Eluting Stent(Xience V, Xience prime) Zotalolimus Eluting Stent(Endeavor-resolute, Resolute Integrity)
DRUGARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.
one or two anti-platelet agents, beta-blockers, calcium channel blockers, nitrates, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and statin
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with CAD and those in whom initial CCS class I to III angina or Braunwald classification less than IIB 2. Patients with age 75 years or older 3. Patients receiving OMT (one or two anti-platelet agents, beta-blockers, calcium channel blockers, nitrates, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and statin) 4. Patients with stenosis of at least 70% in at least one proximal epicardial coronary artery or objective evidence of myocardial ischemia (substantial changes in ST-segment depression or T-wave inversion on the resting electrocardiogram or inducible ischemia with either exercise or pharmacologic vasodilator stress) 5. Patients with signed informed consent
Exclusion criteria
1. Patients with persistence of CCS IV angina 2. Resting chest pain (≥ Braunwald classification IIB) 3. Patients who experienced a markedly positive stress test (substantial ST- segment depression or hypotensive response during stage 1 of the Bruce protocol) 4. Patients with age 85 years or older 5. Patients with refractory CHF or cardiogenic shock 6. Patients with an EF of less than 30% 7. Patients who have received revascularization within the previous 6 months 8. Patients with coronary anatomy not suitable for PCI 9. Life expectancy ≤ 2 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Event | 12month | 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\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cardiac or non-cardiac major adverse event | 12month | 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 |
Countries
South Korea
Contacts
Primary ContactMyeong-Ki Hong, MD.PhD
Outcome results
None listed