Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK)

University of Luebeck

Status and phase: Completed; Phase 4

Conditions: Complications; Acute Myocardial Infarction; Cardiogenic Shock

Treatments: Procedure: Immediate multivessel PCI; Procedure: Culprit Lesion only PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT01927549

CULPRIT-SHOCK1.2

Details and patient eligibility

About

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.

Enrollment: 706 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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706 participants in 2 patient groups

Immediate multivessel PCI

Active Comparator group

Description:

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.

Treatment:

Procedure: Immediate multivessel PCI

Culprit lesion only PCI

Active Comparator group

Description:

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).

Treatment:

Procedure: Culprit Lesion only PCI