Key result
Percutaneous MCS fails to reduce 30-day mortality compared with IABP in severe cardiogenic shock.
Why the study?
Mortality in AMI complicated by cardiogenic shock remains high despite advances, and it is uncertain if pMCS reduces 30-day mortality compared with IABP.
Does percutaneous mechanical circulatory support reduce 30-day all-cause mortality in mechanically ventilated patients with severe cardiogenic shock complicating acute myocardial infarction compared to an intra-aortic balloon pump?
RCT (n=48)
Open-label
randomized
Yes
Does percutaneous mechanical circulatory support reduce 30-day all-cause mortality in mechanically ventilated patients with severe cardiogenic shock complicating acute myocardial infarction compared to an intra-aortic balloon pump?
In patients with severe cardiogenic shock complicating acute myocardial infarction, routine use of percutaneous mechanical circulatory support did not significantly reduce 30-day mortality compared to an intra-aortic balloon pump.
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.
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Ouweneel et al. (2016) conducted an RCT in severe cardiogenic shock complicating acute myocardial infarction (n=48). percutaneous mechanical circulatory support (Impella CP) vs. intra-aortic balloon pump (IABP) was evaluated on 30-day all-cause mortality (HR 0.96, 95% CI 0.42 to 2.18, p=0.92). Percutaneous mechanical circulatory support did not reduce 30-day mortality compared with an intra-aortic balloon pump in patients with severe cardiogenic shock (46% vs 50%; HR 0.96; P=0.92).
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