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
试验速览
- 阶段
- 4 期
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiac Event
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 84 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PCI+OMT group
PCI (Everolimus Eluting Stent or Zotalolimus Eluting Stent) added to OMT after randomization and follow up for 12 months
干预措施: Everolimus Eluting Stent or Zotalolimus Eluting Stent (Device)
OMT alone group
OMT alone after randomization and follow up for 12 months
干预措施: ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc. (Drug)
结局指标
主要结局
Major Adverse Cardiac Event
时间窗: 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\]
次要结局
- cardiac or non-cardiac major adverse event(12month)
研究者
Myeong-Ki Hong
Professor
Yonsei University