Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock

Phase 4

Completed

• Conditions: Acute Myocardial Infarction; Complications; Cardiogenic Shock
• Interventions: Procedure: Culprit Lesion only PCI; Procedure: Immediate multivessel PCI

• Registration Number: NCT01927549
• Lead Sponsor: University of Luebeck

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-19
• Study First Posted: 2013-08-22
• Primary Completion: 2017-07
• Study Completion: 2017-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 706

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)

1. Systolic blood pressure less than 90 mmHg for more than 30 min or
2. 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Culprit lesion only PCI	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).
Immediate multivessel PCI	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.

Primary Outcome Measures

Name	Time	Method
30-day mortality and/or severe renal failure requiring renal replacement therapy	30 days

Secondary Outcome Measures

Name	Time	Method
Serial creatinine-level creatinine-clearance	30 days
Time to hemodynamic stabilization	30 days
30-day mortality	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

Trial Locations

Locations (3)

University of Goettingen; 🇩🇪 Goettingen, Germany

University of Leipzig - Heart Center; 🇩🇪 Leipzig, Germany

Heart Center Leipzig - University Hospital; 🇩🇪 Leipzig, Germany