CLINICAL TRIAL

DanGer Shock RCT1

Kaplan Meier curve DanGer RCT Kaplan Meier curve DanGer RCT

DanGer Shock Randomized Controlled Trial (RCT) Confirms Routine Use of Impella® Improves Survival in Heart Attack with Shock

This investigator-initiated study is the first RCT of Impella in cardiogenic shock (CS), assessed the efficacy of Impella CP® with or without SmartAssist® heart pumps in treating patients with AMI-CS due to STEMI, undergoing emergency PCI.

DanGer Shock RCT Design Infographic showing study design, 3 countries, enrollment numbers and the age range of patients enrolled DanGer Shock RCT Design Infographic showing study design, 3 countries, enrollment numbers and the age range of patients enrolled

Trial Objective:

To determine whether left ventricular (LV) mechanical circulatory support with Impella CP® with SmartAssist heart pump improves survival in patients suffering CS with STEMI compared to standard care.

 

Routine Impella CP Use Reduces 180-Day All-Cause Mortality with AMI-CS Due to STEMI

The DanGer Shock RCT1 confirms Impella CP® improves survival by 12.7%, compared to the control arm treated without Impella devices, in heart attack with shock.1 This independent investigator-initiated study represents a landmark as:

  • The first RCT in AMICS trial history to achieve its primary endpoint.
  • The first RCT in the MCS device trial history to demonstrate a survival benefit in AMICS.

Patients Randomized 1:1

DanGer Shock RCT Endpoints and Timeframe chart

Inclusion Criteria

STEMI

ST-elevation of the J-point in two contiguous ECG leads ≥0.2 mV in men, or ≥0.15 mV in woman in leads V2-V3, or >0.1 mV in other leads for both genders. In addition patients presenting with STEMI equivalent according to ESC guidelines 2017 with presumed new proximal occlusion of a coronary artery are also a candidate for inclusion.

Cardiogenic Shock

A. peripheral sign of tissue hypoperfusion with arterial blood lactate ≥2.5 mmol/L or SvO2 < 55%, 
B. persistent (<30 min) systolic blood pressure less than 100 mmHg and/or need for vasoactive therapy and
C. left ventricular ejection fraction of less than 45% on echocardiography.

Timing

Patients can be enrolled at presentation to catheterization laboratory before PCI and up to 12 hours after intervention.

Exclusion Criteria

  • Shock duration > N24 hours
  • Other causes of shock; hypovolemia, sepsis, pulmonary embolism or anaphylaxis
  • Shock due to mechanical complication of myocardial infarction; papillary muscle rupture, rupture of the ventricular septum or rupture of ventricular free wall.
  • Severe aortic valve regurgitation/stenosis
  • Severe peripheral arterial obstructive disease that would preclude Impella device placement
  • Mechanical aortic valve prosthesis
  • Already established mechanical circulatory support (Impella or VA-ECMO)
  • Left ventricular thrombus
  • Infective endocarditis
  • Shock due to right ventricular failure
  • Out of hospital cardiac arrest with persistent Glasgow coma scale <b8 after return of spontaneous circulation. Cardiac arrest occurring in ambulance or after arrival to hospital is not an exclusion criterion.
  • Subject with documented heparin induced thrombocytopenia.
  • Life expectancy of less than one year due to comorbidities.
  • Mental disorder or language barrier that preclude informed consent.

Other important safety information can be found at https://www.heartrecovery.eu/safety-information

References

  1. Møller, J., et al. (2024). Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock. N Engl J Med.

*based on onset of shock enrollment was permitted up to 12 h after PCI

NPS-4323