COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

Percutaneous Mechanical Circulatory Support Versus Intra-Aortic Balloon Pump in Cardiogenic Shock After Acute Myocardial Infarction

Dagmar M Ouweneel, Erlend Eriksen, Krischan D Sjauw, Ivo M van Dongen, Alexander Hirsch, Erik J S Packer, M Marije Vis, Joanna J Wykrzykowska, Karel T Koch, Jan Baan, Robbert J de Winter, Jan J Piek, Wim K Lagrand, Bas A J M de Mol, Jan G P Tijssen, José P S Henriques
Journal of the American College of Cardiology 2017 January 24, 69 (3): 278-287
27810347

BACKGROUND: Despite advances in treatment, mortality in acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) remains high. Short-term mechanical circulatory support devices acutely improve hemodynamic conditions.

OBJECTIVES: The aim of this study was to determine whether a new percutaneous mechanical circulatory support (pMCS) device (Impella CP, Abiomed, Danvers, Massachusetts) decreases 30-day mortality when compared with an intra-aortic balloon pump (IABP) in patients with severe shock complicating AMI.

METHODS: In a randomized, prospective, open-label, multicenter trial, 48 patients with severe CS complicating AMI were assigned to pMCS (n = 24) or IABP (n = 24). Severe CS was defined as systolic blood pressure <90 mm Hg 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 pMCS was similar (50% and 46%, respectively; hazard ratio with pMCS: 0.96; 95% confidence interval: 0.42 to 2.18; p = 0.92). At 6 months, mortality rates for both pMCS and IABP were 50% (hazard ratio: 1.04; 95% confidence interval: 0.47 to 2.32; p = 0.923).

CONCLUSIONS: In this explorative randomized controlled trial involving mechanically ventilated patients with CS after AMI, routine treatment with pMCS was not associated with reduced 30-day mortality compared with IABP. (IMPRESS in Severe Shock; NTR3450).

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