A Randomized Trial of Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization Strategies & an Observational Study of Optical Coherence Tomography in Patients With Acute MI & Multivessel Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,100
- 试验地点
- 113
- 主要终点
- Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR
研究概览
简要总结
COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI).
COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.
详细描述
COMPLETE-2 STUDY OBJECTIVES
- To determine whether a strategy of physiology-guided complete revascularization is non-inferior to a strategy of angiography-guided complete revascularization on the efficacy composite outcome of cardiovascular (CV) death, new myocardial infarction (MI) or ischemia-driven revascularization (IDR).
- To determine whether a physiology-guided complete revascularization strategy is superior to an angiography-guided complete revascularization strategy in reducing the safety composite outcome of clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.
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
- Single (Outcomes Assessor)
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 presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
- •Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria:
- •Amenable to successful treatment with PCI
- •At least 50% diameter stenosis by visual estimation
- •At least 2.5 mm in diameter
- •Planned complete revascularization strategy for qualifying MI
排除标准
- •Planned or prior coronary artery bypass graft (CABG) surgery
- •Inability to clearly identify a culprit lesion for STEMI or NSTEMI based on angiographic appearance and/or ECG changes and/or regional wall motion abnormalities
- •Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
- •Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
- •Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or >90% visual diameter stenosis
- •Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culprit lesion (patients with a CTO plus additional qualifying non-culprit lesions are eligible)
- •The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
- •Baseline STEMI or NSTEMI was due to a suspected non-atherothrombotic mechanism such as type 2 MI (supply-demand mismatch), including spontaneous coronary artery dissection or coronary artery embolism
- •Non-cardiovascular co-morbidity with expected life expectancy <2 years
- •Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up
研究组 & 干预措施
Physiology-guided Non-Culprit-Lesion (NCL) PCI
Patients randomized to this group will have their physiology assessment using RFR and/or FFR of all qualifying NCLs that were identified prior to randomization. Other validated non-hyperemic physiology ratios (eg. iFR) may only be used when RFR is not available.
干预措施: Physiology-guided NCL PCI (Procedure)
Angiography-guided NCL PCI
Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization.
干预措施: Angiography-guided NCL PCI (Procedure)
结局指标
主要结局
Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR
时间窗: at study completion, a minimum of 2 years
Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury.
时间窗: at study completion, a minimum of 2 years
次要结局
- Time to first occurrence of the composite of CV death or new MI.(at study completion, a minimum of 2 years)
- Net clinical outcome: Time to first occurrence of the composite of CV death, new MI, clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.(at study completion, a minimum of 2 years)