PRIME-SHOCK is a prospective, single-center, open-label, randomized, superiority trial. Eligible participants with AMICS and a clinical decision to use Impella CP will be randomized in a 1:1 ratio before culprit-lesion PCI. The routine pre-PCI group will undergo Impella CP insertion immediately after allocation and before culprit-lesion PCI. The selective post-PCI group will undergo culprit-lesion PCI first; Impella CP will be inserted only if prespecified intra-procedural rescue criteria are met or shock persists or worsens after successful PCI. If all post-PCI recovery criteria are met, PCI will be concluded without Impella CP.
Age ≥19 years old
Acute myocardial infarction with culprit lesion requiring urgent percutaneous coronary intervention
Cardiogenic shock before culprit lesion percutaneous coronary intervention
Left ventricular ejection fraction ≤40%
Non-acute myocardial infarction-related shock
No clear culprit lesion
Mechanical complication of myocardial infarction
Predominant right ventricular or biventricular shock
Parallel
Routine pre-PCI Impella CP
Procedure/SurgeryIn the PCI Impella CP group, Impella CP will be routinely inserted before culprit lesion PCI in patients with acute myocardial infarction-related cardiogenic shock.
Selective post-PCI Impella CP
Procedure/SurgeryThe selective post-PCI Impella CP group will undergo culprit-lesion PCI first; Impella CP will be inserted only if prespecified intra-procedural rescue criteria are met or shock persists or worsens after successful PCI for culprit lesion. In the selective post-PCI group, immediate mechanical circulatory support will be instituted during PCI if any of the criteria are met. Impella CP is preferred when feasible. VA-ECMO may be initiated during resuscitation when Impella CP cannot be placed promptly or is insufficient. In the selective post-PCI group, successful culprit-lesion revascularization is done without shock progession, PCI will be concluded without Impella CP only when all of the criteria are met.
Composite of all-cause death or refractory shock within 48 hours after index percutaneous coronary intervention
Composite of all-cause death or refractory shock within 48 hours after index percutaneous coronary intervention
All-cause death
Number of participants with refractory shock within 48 hours after index percutaneous coronary intervention (PCI), assessed using prespecified clinical, hemodynamic, and arterial lactate criteria
Refractory shock is defined as any of: (1) rescue escalation to mechanical circulatory support beyond the randomized strategy, (2) acute cardiac arrest, or (3) persistent or worsening tissue hypoperfusion requiring at least one arterial lactate criterion AND at least one concurrent hemodynamic/organ-perfusion criterion. Lactate criteria: two consecutive increases at approximately 2-hour intervals, 24-hour lactate clearance \<40 percent with lactate ≥4 mmol/L at 24 hours, or persistent lactate ≥5 mmol/L during hours 24-48. Concurrent criteria: increasing vasopressor requirement, use of ≥2 vasoactive agents; persistent mean arterial pressure \<65 mm Hg, urine output \<0.5 mL/kg/h for ≥6 hours; cardiac power output \<0.6 W, or cardiac index \<2.2 L/min/m\^2. Protocol-concordant post-PCI Impella CP insertion in the selective group is not, by itself, rescue escalation.
Time from randomization to arterial lactate <2.0 mmol/L
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