CLINICAL TRIAL

DanGer Shock RCT¹

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

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

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

DanGer Shock RCT1