a Multinational, Multicenter, Prospective, Open-label, Active-treatment-controlled Randomized Trial: Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque_PREVENT Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,608
- 试验地点
- 18
- 主要终点
- Target vessel failure
研究概览
简要总结
The primary aim of the trial is to determine whether preventive PCI with bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) plus optimal medical therapy (OMT) on functionally insignificant (FFR > 0.80) vulnerable coronary plaque, as determined by intracoronary imaging, would result in a significant reduction of the primary composite outcome of death from cardiac causes, target-vessel myocardial infarction (MI), target-vessel revascularization (TVR), and hospitalization for unstable or progressive angina at 2 years, when compared with OMT alone.
详细描述
Sub-analysis for each imaging test will be performed as below;
- NIRS(Near-infrared spectroscopy)
- OCT(Optical coherence tomography)
- VH-IVUS(IVUS-derived virtual histology)
- IVUS(Intravascular ultrasonography)
Extended follow-up:
Considering the nature of functionally insignificant coronary stenosis with vulnerable plaque, most subjects are watched for extended follow-up after the planned 2-year follow-up time point.
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 aged ≥18 years
- •Patients with suspected or known Coronary artery disease who are undergoing invasive cardiac catheterization
- •Patients with at least one significant stenosis (diameter stenosis >50%) with Fractional Flow Reserve (FFR) >0.80 and meeting two of the following criteria:
- •MLA(minimal luminal area)<4mm2
- •Plaque burden>70%
- •Large lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy), defined as MaxLCBI4mm>315
- •TCFA(thin-cap fibroatheroma) defined as fibrous cap thickness <65 μm and arc >90° on optical coherence tomography (OCT) or ≥10% confluent necrotic core with >30° abutting the lumen in three consecutive slices on Virtual-histology intravascular ultrasound (VH-IVUS)
- •Eligible for percutaneous coronary intervention with Absorb Bioresorbable Vascular Scaffold or Everolimus Eluting Stent
- •Reference vessel diameter 2.75-4.0
- •Lesion length ≤ 40mm
- •Willing and able to provide informed written consent
排除标准
- •Patients for whom the preferred treatment is CABG(Coronary artery bypass grafting)
- •Patients with stented lesions
- •Patients with bypass graft lesions
- •Patients with three or more target lesions
- •Patients with two target lesions in the same coronary territory
- •Patients with heavily calcified or angulated lesions
- •Patients with bifurcation lesions requiring 2 stenting technique
- •Patients with contraindications to or planned discontinuation of dual antiplatelet therapy within 1 year
- •Patients with life expectancy <2 years
- •Patients with planned cardiac or major noncardiac surgery
- •Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study
研究组 & 干预措施
Coronary intervention
bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) +Optimal Medical Treatment
干预措施: Coronary intervention (Device)
Optimal Medical Treatment
Optimal Medical Treatment
干预措施: Optimal Medical treatment (Drug)
结局指标
主要结局
Target vessel failure
时间窗: 2 years
target-vessel failure, which was defined a composite of death from cardiac causes, target-vessel myocardial infarction, ischemic-driven target-vessel revascularization, or hospitalization for unstable or progressive angina
次要结局
- Hospitalization for unstable or progressive angina(2 years)
- Major adverse cardiac event(2 years)
- Target-vessel myocardial infarction(2 years)
- Ischemic-driven target-vessel revascularization(2 years)
- Repeat revascularization(2 years)
- Target-lesion failure(2 years)
- Myocardial infarction(2 years)
- Any hospitalization for cardiac or noncardiac causes(2 years)
- Rate of Nonurgent revascularization procedures(2 years)
- Functional class(2 years)
- Death from cardiac causes(2 years)
- Death from all, cardiac, or noncardiac causes(2 years)
- Composite of any death, myocardial infarction, or repeat revascularization(2 years)
- Rate of Scaffold or stent thrombosis(2 years)
- Rate of Bleeding events(2 years)
- Number of anti-anginal medications administered(2 years)
- Rate of Stroke(2 years)
研究者
Seung-Jung Park
MD,PhD
Asan Medical Center