DanGer Shock Trial
Details
DanGer Shock is the first randomised trial of a temporary mechanical circulatory support device to show a mortality benefit in cardiogenic shock. It randomised patients with STEMI-related cardiogenic shock to an early microaxial flow pump (Impella CP) versus standard of care, within 24 hours of shock onset, at experienced centres, and excluded patients at risk of hypoxic brain injury. (sources/cardiogenic-shock-acc-2025, rating: very high) (sources/cardiogenic-shock-nejm-2026, rating: very high)
Key Facts
- n = 360, multicentre, randomised, STEMI-CS. (sources/cardiogenic-shock-nejm-2026, rating: very high)
- 180-day mortality: HR 0.74 (95% CI 0.55–0.99; P = 0.04) — a 12.7% absolute mortality reduction, the first positive tMCS RCT. (sources/cardiogenic-shock-acc-2025, rating: very high)
- Benefit was sustained to 10 years in proportional-hazards follow-up. (sources/cardiogenic-shock-nejm-2026, rating: very high)
- Harm signal: more bleeding, limb ischaemia and renal replacement therapy in the pump group. (sources/cardiogenic-shock-nejm-2026, rating: very high)
- Eligibility is the central limitation: only 5% of all cardiogenic-shock patients and 32% of STEMI-CS patients in registry data meet the trial's criteria. (sources/cardiogenic-shock-nejm-2026, rating: very high)
- US guidelines give a Class IIa indication for selected patients. (sources/cardiogenic-shock-nejm-2026, rating: very high)
- An IPD meta-analysis of 9 trials (n=1,059) found no overall mortality benefit, with benefit confined to the LV-dominant, low hypoxic-brain-injury-risk subgroup (HR 0.77; 95% CI 0.61–0.97; P = 0.024). (sources/cardiogenic-shock-nejm-2026, rating: very high)
Contradictions / Open Questions
- The trial is positive while the device class is not. Large propensity-matched studies (>100,000 patients) found no survival benefit and more complications with microaxial pumps, and the IPD meta-analysis is neutral overall. The divergence is best explained by patient selection and centre experience, not by a class effect — but that means the result belongs to the protocol and the centres, not to the device. (sources/cardiogenic-shock-nejm-2026, rating: very high)
- Generalisability is narrow and unquantified outside STEMI-CS. HF-CS is the rising phenotype and is not covered; the trial enrolled no patients at risk of hypoxic brain injury, and the 5%/32% eligibility fractions come from registry analysis rather than the trial itself. (sources/cardiogenic-shock-nejm-2026, rating: very high)
- Whether the 10-year survival signal reflects the device or survivor selection is unresolved; the follow-up is an extension of a trial powered for 180 days.
Connections
- Related to concepts/Cardiogenic-Shock — the syndrome, phenotypes and SCAI staging
- Related to concepts/Cardiogenic-Shock — device selection and the tMCS evidence hierarchy
- Related to entities/ECLS-SHOCK-Trial and entities/IABP-SHOCK-II-Trial — the negative device trials it is contrasted with
- Related to entities/Acute-Coronary-Syndrome — STEMI is the enrolled population