MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction - The MULTISTARS AMI Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 840
- 试验地点
- 2
- 主要终点
- The primary outcome measure is a composite of all-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year
研究概览
简要总结
The primary objective of the trial is to compare, in patients presenting with ST segment elevation myocardial infarction (STEMI) and multi-vessel disease (MVD), the safety and efficacy of immediate complete revascularization of all significant coronary lesions versus culprit vessel only revascularization and staged percutaneous coronary intervention (PCI) of all significant coronary lesions (within 19 to 45 days), in a non-inferiority trial using a third generation, biodegradable-polymer, everolimus-eluting stent.
详细描述
An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with STEMI and MVD in stable hemodynamic conditions, undergoing after successful PCI of the culprit lesion either (1:1 randomization) immediate revascularization of all additional target lesions during the index procedure or staged PCI of all additional target lesions (within 19 to 45 days) using the Boston Scientific Synergy™ stent.
The goal of this trial is to compare two treatment strategies that are currently performed in clinical practice: immediate complete revascularization versus staged complete revascularization in patients with STEMI and MVD.
Patients randomized to immediate complete revascularization will have treated during the index procedure, after revascularization of the culprit lesion, all significant non-culprit coronary lesions.
Patients randomized to staged complete revascularization will have treated during the index procedure only the culprit lesion, and they will be hospitalized after 19-45 days for complete revascularization of all significant non-culprit coronary lesions.
For both groups, lesion are considered significant when causing a ≥70% diameter stenosis by visual estimation in at least two projections on the coronary angiogram.
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
- •Age ≥ 18 years
- •Spontaneous acute STEMI (patients presenting within 24 hours of symptom onset)
- •Suitability for PCI from femoral or radial access
- •Coronary anatomy suitable for complete coronary revascularization with Synergy® stent implantation
- •Identifiable culprit lesion/artery
- •At least one non-culprit coronary stenosis ≥ 70% in at least two projections, in a vessel with a lumen diameter ≥2.25 - ≤5.75 mm, other than the culprit artery
- •TIMI Flow 3 or TIMI flow 2 after revascularization of the culprit artery
- •Stable hemodynamics at the end of the culprit vessel revascularization
排除标准
- •Inability to give informed consent
- •Cardiogenic shock
- •Prolonged resuscitation >10 min
- •General unsuitability for PCI
- •Need for emergency CABG
- •Previous CABG
- •Planned hybrid revascularization
- •Coronary artery dissection
- •STEMI due to ST
- •Previous documented allergic reaction to everolimus or to any stent material
- •Severe mechanical complication of acute myocardial infarction
- •Pre-existing severe renal failure (eGFR <30 mL/min) or renal replacement therapy
- •Chronic total occlusion of a major coronary artery
- •Left main stem stenosis ≥50% or left main stem equivalent (ostial left anterior descending and ostial circumflex stenosis ≥70%)
- •In-stent restenosis
- •Panned coronary, cerebrovascular, or peripheral arterial revascularization
- •Planned cardiac or major surgery
- •Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 Inhibitor for at least 90 days, except for patients on oral anticoagulation
- •Known pregnancy at the time of inclusion
- •Participation in another clinical study with an investigational product
- •Life expectancy <1 year
结局指标
主要结局
The primary outcome measure is a composite of all-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year
时间窗: 1-year
次要结局
- All-cause death(6 months, 1 year)
- Target vessel revascularization (TVR)(6 months, 1 year)
- Non-fatal myocardial infarction(6 months, 1 year)
- Target lesion revascularization (TLR)(6 months, 1 year)
- Hospitalization for heart failure(6 months, 1 year)
- All-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke(6 months)
- Cardiac death(6 months, 1 year)
- Unplanned ischemia-driven revascularization(6 months, 1 year)
- Stroke(6 months, 1 year)
- Quality of life (EQ-5D questionnaire)(6 months, 1 year)
- Non-cardiovascular death(6 months, 1 year)
- Cardiovascular death(6 months, 1 year)
- Cardiac death or myocardial infarction(6 months, 1 year)
- Acute renal insufficiency or dialysis(6 months, 1 year)
- Procedural success(6 months, 1 year)
- Bleeding event (BARC definition)(6 months, 1 year)
- All-cause death or myocardial infarction(6 months, 1 year)
- Stent thrombosis(6 months, 1 year)