Prospective Randomized Multicenter Study Comparing Immediate Multivessel Revascularization by PCI Versus Culprit Lesion PCI With Staged Non-culprit Lesion Revascularization in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 706
- 试验地点
- 5
- 主要终点
- 30-day mortality and/or severe renal failure requiring renal replacement therapy
研究概览
简要总结
The study compares the therapies of instant multivessel balloon angioplasty plus stent implantation or the balloon angioplasty plus stent implantation of the infarct artery alone with any possible graduated later treatment of the other vessels in patients with acute myocardial infarction with cardioganic shock.
The main study hypothesis is to explore if culprit vessel only PCI with potentially subsequent staged revascularization in comparison to immediate multivessel revascularization by PCI in patients with cardiogenic shock complicating acute myocardial infarction reduces the incidence of 30- day mortality and/or severe renal failure requiring renal replacement therapy.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiogenic shock complicating acute myocardial infarction (STEMI or NSTEMI) with obligatory:
- •I) Planned early revascularization by PCI II) Multivessel coronary artery disease defined as more than 70% stenosis in at least 2 major vessels (more than 2 mm diameter) with identifiable culprit lesion III)
- •Systolic blood pressure less than 90 mmHg for more than 30 min or
- •catecholamines required to maintain pressure more than 90 mmHg during systole and IV) Signs of pulmonary congestion V) Signs of impaired organ perfusion with at least one of the following criteria
- •a) Altered mental status b) Cold, clammy skin and extremities c) Oliguria with urine output less than 30 ml/h d) Serum-lactate more than 2.0 mmol/l VI) Informed consent
排除标准
- •Resuscitation more than 30 minutes
- •No intrinsic heart action
- •Cerebral deficit with fixed dilated pupils (not drug-induced)
- •Need for primary urgent bypass surgery (to be determined after diagnostic angiography)
- •Single vessel disease
- •Mechanical cause of cardiogenic shock
- •Onset of shock more than 12 h
- •Massive lung emboli
- •Age more than 90 years
- •Shock of other cause (bradycardia, sepsis, hypovolemia, etc.)
- •Other severe concomitant disease with limited life expectancy <6 months
- •Pregnancy
- •Known severe renal insufficiency (creatinine clearance <30 ml/kg)
研究组 & 干预措施
Immediate multivessel PCI
After diagnostic angiography the culprit lesion is identified and PCI should be performed using standard techniques. The use of drug-eluting stents is recommended but not mandatory. All additional lesions in other major coronary arteries defined by a diameter >2 mm with high grade stenoses (>70% by visual assessment) should be intervened using standard techniques. Other major coronary arteries are defined by stenoses of other vessels and are not confined to a diagonal branch if the left anterior descending coronary artery was identified as the culprit lesion.
干预措施: Immediate multivessel PCI (Procedure)
Culprit lesion only PCI
After diagnostic angiography the culprit lesion is identified and PCI of the culprit lesion should be performed using standard techniques. The use of drug-eluting stents is recommended but not mandatory. All other lesions should be left untreated in the acute setting. Complete revascularization of the non-culprit lesions may be performed at a later time point as staged procedure depending on remaining ischemia (as per guideline recommendations either by PCI or CABG).
干预措施: Culprit Lesion only PCI (Procedure)
结局指标
主要结局
30-day mortality and/or severe renal failure requiring renal replacement therapy
时间窗: 30 days
次要结局
- Time to hemodynamic stabilization(30 days)
- 30-day mortality(30 days)
- Serial creatinine-level creatinine-clearance(30 days)
- Death or recurrent infarction at 12 months follow-up(12 months)
- Rehospitalization for congestive heart failure within 12 months follow-up(12 months)
- Quality of life at 6 and 12 months assessed using Euroqol 5D (EQ-5D)(12 months)
- Maximum creatine kinase-MB level(30 days)
- Maximum troponin level(30 days)
- Requirement of renal replacement therapy(30 days)
- Requirement and length of mechanical ventilation(30 days)
- All-cause death within 12 months follow-up(12 months)
- Recurrent infarction within 30-days follow-up(30 days)
- Duration of catecholamine therapy(30 days)
- Length of ICU-stay(30 days)
- Serial intensive care scoring (SAPS-II score) until stabilization(30 days)
- Peak creatine kinase level during hospital stay(30 days)
- Death/recurrent infarction/rehospitalization for congestive heart failure within 12 months(12 months)
- Need for repeat revascularization (PCI and/or CABG) within 12 months follow-up(12 months)
- Recurrent infarction within 12 months follow-up(12 months)
研究者
Holger Thiele
Coordinator
Heart Center Leipzig - University Hospital