The Beneficial Role of Percutaneous Coronary Intervention Over Optimal Medical Therapy in Elderly Patients With Coronary Artery Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Beneficial Role of Percutaneous Coronary Intervention Over Optimal Medical Therapy in Elderly Patients (Age > 75 Years Old) With Coronary Artery Disease: a Randomized Controlled Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Everolimus Eluting Stent or Zotalolimus Eluting Stent
* Drug: ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with CAD and those in whom initial CCS class I to III angina or Braunwald classification less than IIB Patients with age 75 years or older 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) 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) Patients with signed informed consent Exclusion Criteria: Patients with persistence of CCS IV angina Resting chest pain (≥ Braunwald classification IIB) Patients who experienced a markedly positive stress test (substantial ST- segment depression or hypotensive response during stage 1 of the Bruce protocol) Patients with age 85 years or older Patients with refractory CHF or cardiogenic shock Patients with an EF of less than 30% Patients who have received revascularization within the previous 6 months Patients with coronary anatomy not suitable for PCI Life expectancy ≤ 2 year

Ages Eligible for Study
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Minimum Age: 75 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCI+OMT group<br>PCI (Everolimus Eluting Stent or Zotalolimus Eluting Stent) added to OMT after randomization and follow up for 12 months | Device: Everolimus Eluting Stent or Zotalolimus Eluting Stent<br>* Everolimus Eluting Stent(Xience V, Xience prime) Zotalolimus Eluting Stent(Endeavor-resolute, Resolute Integrity)<br>|
| Active Comparator: OMT alone group<br>OMT alone after randomization and follow up for 12 months | Drug: ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.<br>* one or two anti-platelet agents, beta-blockers, calcium channel blockers, nitrates, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and statin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major 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] | 12month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac or non-cardiac major adverse event | 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. Major determinant for the occurrence of major events Sub-study according to the subsets of disease Association between parameters at index procedure and clinical outcomes | 12month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease 75years of age or older