The following is a summary of “Microaxial Flow Pump in Infarct-Related Cardiogenic Shock – DanGer Shock,” published in the April 2024 issue of Cardiology by Kumbhani et al.
Despite a higher risk of complications in patients with ST-segment elevation myocardial infarction (STEMI) and cardiogenic shock, the DanGer Shock trial suggests routine microaxial flow pump insertion (Impella CP) on top of standard care produces better results than standard care alone in 6-month mortality.
Researchers conducted a prospective study to compare the safety and efficacy of Impella CP with ST-segment elevation myocardial infarction (STEMI) and cardiogenic shock.
They screened 1,211 patients and randomized 355 into a 1:1 cohort to either Impella CP and standard care (n = 179) or standard care alone (n = 176). A total of 355 patients (21% females) were selected for the trial, with a median age of 68 years and a 6-month follow-up period. Randomization was stratified to the timing of the revascularization procedure and localization of STEMI (anterior vs. non-anterior).
The results showed that all-cause mortality at 6 months for Impella CP + standard care was 45.8% vs. 58.5% in standard care alone (HR 0.74, 95% CI 0.55-0.99, P=0.04). At 6 months, the composite outcome (escalation of treatment, heart transplant, or death) was 52.5% vs. 63.6% (HR 0.72, 95% CI 0.55-0.95). The composite safety endpoint was 24.0% vs. 6.2% (HR 4.74, 95% CI 2.36-9.55). Moderate/severe bleeding: 21.8% vs. 11.9% (P< 0.05). Limb ischemia: 5.6% vs. 1.1% (P< 0.05). Need for renal replacement therapy: 41.9% vs. 26.7% (P< 0.05). Sepsis with positive blood culture: 11.7% vs. 4.5% (P< 0.05).
Investigators concluded that Impella CP, alongside standard care, reduces 6-month mortality but raises risks of bleeding, limb ischemia, RRT need, and sepsis.
Source: acc.org/Latest-in-Cardiology/Clinical-Trials/2024/04/05/04/44/danger-shock