Ouweneel DM, Eriksen E, Sjauw KD, van Dongen IM, Hirsch A, Packer EJ, Vis MM, Wykrzykowska JJ, Koch KT, Baan J, de Winter RJ, Piek JJ, Lagrand WK, de Mol BA, Tijssen JG, Henriques JP.; J Am Coll Cardiol. 2016 Oct 27. pii: S0735-1097(16)36767-5.
BACKGROUND: Despite advances in treatment, mortality in acute myocardial infarction complicated by cardiogenic shock remains high. Short-term mechanical circulatory support devices acutely improve hemodynamic conditions. The Impella CP is a new percutaneous circulatory support device that provides more hemodynamic support than the intra-aortic balloon pump (IABP).
OBJECTIVES: The aim of this study was to determine whether the Impella CP can decrease 30-day mortality when compared with IABP in patients with severe shock complicating acute myocardial infarction.
METHODS: In a randomized, prospective, open-label, multi-center trial, we assigned 48 patients with severe cardiogenic shock complicating acute myocardial infarction to Impella CP (n=24) or IABP (n=24). Severe cardiogenic shock was defined as systolic blood pressure lower than 90 mmHg or the need for inotropic or vasoactive medication and the requirement for mechanical ventilation. The primary endpoint was 30-day all-cause mortality.
RESULTS: At 30 days, mortality in patients treated with either IABP or Impella CP was similar (50% and 46%, respectively, hazard ratio (HR) with Impella CP, 0.96 (95% confidence interval (CI) 0.42 to 2.18; p=0.92). At 6 months, mortality rates for both Impella CP and IABP were 50% (HR 1.04 (95% CI; 0.47-2.32, p=0.923).
CONCLUSIONS: In this explorative randomized controlled trial involving mechanically ventilated cardiogenic shock patients after acute myocardial infarction, routine treatment with Impella CP was not associated with reduced 30-day mortality compared with IABP.