Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 3 Extended A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
Coronary artery disease, or narrowing of the blood vessels that provide blood to the heart, is the most common cause of death in the United States and can be treated with either coronary bypass surgery or coronary stent placement. This study will evaluate outcomes, including death and quality of life, at 10 years in 1,500 patients with coronary disease who have already been randomized to either bypass surgery or stenting.
详细描述
Coronary artery disease (CAD) remains the major cause of morbidity and mortality in adults in the United States. In patients with 3-vessel CAD not involving the left main coronary artery, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) can improve outcomes. Older studies have shown that the more invasive option, CABG, significantly reduces mortality during long-term follow-up compared with PCI. However, these studies did not use contemporary methods to perform PCI, such as measuring an index called fractional flow reserve (FFR) with a coronary pressure wire or using current- generation drug-eluting stents (DES), both of which significantly improve outcomes after PCI. The Fractional flow reserve versus Angiography for Multivessel Evaluation (FAME) 3 trial randomized 1,500 patients to FFR-guided PCI with current generation DES or to CABG and found that at 5 years there was no significant difference in the composite of death, myocardial infarction (MI) or stroke between the two strategies. There was a reduction in MI in the CABG group. Longer-term follow-up is critical to determine if contemporary PCI results in similar survival as CABG. The primary aim of this project is to determine if 10-year mortality is different after FFR-guided PCI compared with CABG. Investigators will perform 10-year follow-up in the 1,500 patients randomized in the FAME 3 trial to determine if FFR-guided PCI is non-inferior to CABG with respect to mortality. Secondary aims include assessing quality of life and angina relief at 10 years in the two groups. Additionally, investigators will compare individual rates of secondary clinical outcomes including MI, stroke, and repeat revascularization at 10-year follow-up after PCI or CABG.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years with angina and/or evidence of myocardial ischemia
- •Three vessel CAD, defined as ≥ 50% diameter stenosis by visual estimation in each of the three major epicardial vessels or major side branches, but not involving left main coronary artery, and amenable to revascularization by both PCI and CABG as determined by the Heart Team. Patients with a non-dominant right coronary artery may be included if only the left anterior descending artery (LAD) and left circumflex have
- •≥50% stenosis
- •Willing and able to provide informed, written consent
排除标准
- •Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, carotid revascularization), however a maze procedure or pulmonary vein isolation is allowed
- •Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
- •Recent STEMI (<5 days prior to randomization)
- •Ongoing Non STEMI with biomarkers (cardiac troponin) still rising
- •Known left ventricular ejection fraction <30%
- •Life expectancy < 2 years
- •Requiring renal replacement therapy
- •Undergoing evaluation for organ transplantation
- •Participation or planned participation in another clinical trial, except for observational registries
- •Inability to take dual antiplatelet therapy or anticoagulation and single antiplatelet therapy for at least six months
- •Previous CABG
- •Left main disease requiring revascularization
- •Extremely calcified or tortuous vessels precluding FFR measurement
- •Any target lesion with in-stent drug-eluting stent restenosis
- •More than one major epicardial vessel which is chronically occluded
结局指标
主要结局
Survival
时间窗: 10-year follow-up
The primary outcome is mortality or overall survival
次要结局
- Quality of life(10-year follow-up)
- Angina Relief(10 year follow-up)
研究者
William Fearon
MD, Professor of Medicine
Stanford University