Multi Centre Open Label Randomised Controlled Parallel-group Three Arm Trial To Compare The Use Of Fractional Flow Reserve (FFR) Guided and Angiographically Guided Revascularization To The Treatment Of Infarct Related Artery Only In Patients With STEMI And Multivessel Disease
试验速览
- 阶段
- 3 期
- 入组人数
- 560
- 试验地点
- 3
- 主要终点
- Composite of cardiovascular death, myocardial infarction and / or revascularization
研究概览
简要总结
In patients with ST elevation myocardial infarction (STEMI) the treatment goal is revascularization of the occluded artery with the use of primary percutaneous coronary intervention (PCI). There is a large subset of patients with STEMI who also have significant disease in arteries other than the site of occlusion, and away from the culprit artery. It is estimated that up to 50% have disease of more than 50% in the non-culprit arteries.
The evidence on how to treat those patients with multi vessel disease is conflicting. Earlier large-scale studies and registries have suggested early and complete revascularization is of no benefit or even harmful. More recent studies have showed the opposite of that. The CVLPRIT study showed that early complete revascularization or preventive PCI reduced primary endpoint of a composite of all cause mortality, myocardial infarction and need for repeat revascularization. The benefit was mainly due to reduced repeat revascularization in the more intensive intervention group. The PRAMI study showed very similar results as well.
The use of Fractional flow Reserve (FFR) in deciding complete revascularization has also showed conflicting results so far. A previous trial showed that FFR guided intervention post STEMI increased MACE. This was conflicted with more recent study, which showed FFR guided complete revascularization improved outcome when compared with more conservative treatment of ischaemia driven intervention.
In this study, the investigators are going to assess the issue of staged revascularization guided by FFR or by angiogram, compared to the standard treatment of ischaemia driven revascularization
详细描述
To compare the clinical outcomes measured by composite of mortality, myocardial infarction and repeat revascularization by using FFR guided and angiographically guided revascularization to the standard strategy of ischaemia driven revascularization.
Participants will be allocated to three arms, first conservative group of ischaemia guided PCI, second FFR guided PCI and third angiogram guided PCI where patients where patients with more than 50% lesion will undergo revascularization.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with STEMI and multi-vessel disease on initial angiogram.
- •Above 18 years of age
- •Able to give consent
排除标准
- •Patients with indication for CABG
- •Left main stem lesion of >50%
- •Cardiogenic shock
- •Intractable angina during hospital admission
- •Patients with limited life expectancy
- •Patients with severe chronic kidney disease
- •Patients with contraindication to dual antiplatelet therapy
- •Patients with very complex lesions that deemed not favourable for PCI
- •Pregnancy or childbearing age
结局指标
主要结局
Composite of cardiovascular death, myocardial infarction and / or revascularization
时间窗: 1 year
次要结局
- Myocardial infarction(1 year)
- Revascularization(1 year)
- Cardiovascular morality(1 year)
- stroke(1 year)
- Costs(1 year)
- Heart failure(1 year)
研究者
A Abdullah
Dr.
University of Limerick