Randomized Comparative Effectiveness Study of Complete vs Culprit-only Revascularization Strategies to Treat Multi-vessel Disease After Early Percutaneous Coronary Intervention (PCI) for ST-segment Elevation Myocardial (STEMI) Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,042
- 试验地点
- 1
- 主要终点
- Composite of Cardiovascular death or new myocardial Infarction
研究概览
简要总结
To determine whether, on a background of optimal medical therapy, including ticagrelor, opening of all suitable narrowings or blockages found at the time of primary PCI for an acute heart attack is better than treating only the culprit lesion in patients with multi-vessel disease.
详细描述
To determine if a strategy of multivessel revascularization involving PCI of all suitable non-infarct related artery lesions plus optimal medical therapy is superior to a strategy of optimal medical therapy alone in reducing (1) the composite outcome of cardiovascular (CV) death or new myocardial infarction (MI), or (2) the composite of CV death, new MI or ischemia driven revascularization (IDR) in patients with multivessel disease who have undergone early successful culprit lesion PCI for STEMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Men and women within 72 hours after successful PCI (preferably using a drug eluting stent) to the culprit lesion for STEMI. PCI for STEMI can be either primary PCI or rescue PCI for failed fibrinolysis or a combination strategy where PCI is performed routinely 3-12 hours after fibrinolysis AND
- •Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has:
- •At least 70% diameter stenosis (visual estimation) or
- •At least 50% diameter stenosis (visual estimation) with fractional flow reserve (FFR) ≤ 0.80
排除标准
- •Planned revascularization of non-culprit lesion
- •Planned surgical revascularization
- •Non-cardiovascular co-morbidity reducing life expectancy to < 5 years
- •Any factor precluding 5 year follow-up
- •Prior Coronary Artery Bypass Graft (CABG) Surgery
研究组 & 干预措施
Complete Revascularization Strategy
Complete Revascularization Strategy (Staged Non-Culprit Lesion PCI plus Optimal Medical Therapy): Staged PCI using second generation drug eluting stents (Promus Element Plus drug-eluting stent or newer version in this series is strongly recommended) of all suitable non-culprit lesions.
All patients, regardless of randomized treatment allocation will receive optimal medical therapy consisting of risk factor modification and use of evidence-based therapies (including low dose acetylsalicylic acid (ASA) and ticagrelor).
干预措施: Complete Revascularization Strategy (Procedure)
Optimal Medical Therapy Alone
Culprit lesion only Revascularization Strategy (Optimal Medical Therapy Alone): No further revascularization of non-culprit lesions.
All patients, regardless of randomized treatment allocation will receive optimal medical therapy consisting of risk factor modification and use of evidence-based therapies (including low dose ASA and ticagrelor).
结局指标
主要结局
Composite of Cardiovascular death or new myocardial Infarction
时间窗: over duration of follow-up (average of approximately 4 years)
Co-primary outcome: CV death or new MI
Composite of cardiovascular death, new myocardial infarction or ischemia-driven revascularization
时间窗: over duration of follow-up (average of approximately 4 years)
Co-primary outcome: CV death, new MI or IDR
次要结局
- Composite of CV death, new MI, ischemia-driven revascularization or hospitalization for unstable angina or heart failure(Over duration of follow-up (average of approximately 4 years))