LandmarkRCT

DanGer Shock

Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock

New England Journal of Medicine, 2024 · International, multicenter, randomized, open-label trial.

Clinical question

In STEMI-related cardiogenic shock, does routine use of a microaxial flow pump (Impella CP) added to standard care improve survival compared with standard care alone?

Population: 355 patients with STEMI and cardiogenic shock.
Intervention: Microaxial flow pump (Impella CP) plus standard care.
Comparator: Standard care alone.
Primary outcome: All-cause mortality at 180 days.
Secondary outcomes: Composite safety endpoint: severe bleeding, limb ischemia, hemolysis, device failure, worsening aortic regurgitation.
Result: Reduced 180-day mortality with the microaxial flow pump, but a higher rate of the composite safety endpoint (bleeding, limb ischemia, hemolysis, device complications). (Absolute 180-day mortality reduction of approximately 12.7 percentage points)

What the trial found

Routine use of a microaxial flow pump in STEMI-related cardiogenic shock reduced 180-day mortality, at the cost of significantly more bleeding, limb ischemia, and other device-related complications.

Current guideline position

In the 2025 ACC/AHA ACS guideline, use of a microaxial flow pump is considered reasonable in selected patients with AMI-related cardiogenic shock to reduce mortality, while emphasizing increased bleeding, limb ischemia, and renal complications.

Clinical interpretation

This is the first RCT to show a mortality benefit from a mechanical circulatory support device in cardiogenic shock, a genuinely practice-relevant result — but it is a single trial, in a population restricted to STEMI-related shock, with a real and significant complication trade-off. It should not be read as establishing benefit for cardiogenic shock from all causes, or as a device without meaningful downside.

Limitations

Open-label design.
Restricted to STEMI-related cardiogenic shock — does not establish benefit in other etiologies.
Significantly higher rate of bleeding, limb ischemia, and device-related complications in the intervention arm.

Moderate certainty

Clinical Context & Relevant Topics (1)

Disease Reference

Cardiogenic Shock

Primary pump failure, SCAI staging (A–E), PAC hemodynamics (CPO, PAPi), inotrope selection, emergent revascularization, and mechanical circulatory support.

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