Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cardiogenic Shock, Acute Myocardial Infarction, Complications

Intervention / Treatment
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* Procedure: Immediate multivessel PCI
* Procedure: Culprit Lesion only PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate multivessel PCI<br>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. | Procedure: Immediate multivessel PCI<br> <br> |
| Active Comparator: Culprit lesion only PCI<br>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). | Procedure: Culprit Lesion only PCI<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality and/or severe renal failure requiring renal replacement therapy |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality |  | 30 days | 
| Requirement of renal replacement therapy |  | 30 days | 
| Time to hemodynamic stabilization |  | 30 days | 
| Duration of catecholamine therapy |  | 30 days | 
| Serial creatinine-level creatinine-clearance |  | 30 days | 
| Length of ICU-stay |  | 30 days | 
| Serial intensive care scoring (SAPS-II score) until stabilization |  | 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 | 
| Death or recurrent infarction at 12 months follow-up |  | 12 months | 
| Rehospitalization for congestive heart failure within 12 months follow-up |  | 12 months | 
| 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 | 
| Peak creatine kinase level during hospital stay |  | 30 days | 
| 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 | 
| Recurrent infarction within 12 months follow-up |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiogenic shock, infarction, multivessel coronary artery disease, angioplasty