Meta-Analysis and Trial Sequential Analysis Comparing Percutaneous Ventricular Assist Devices Versus Intra-Aortic Balloon Pump During High-Risk Percutaneous Coronary Intervention or Cardiogenic Shock

Abstract

The intra-aortic balloon pump (IABP) and percutaneous ventricular assist devices (pVAD) are commonly used in different clinical scenarios. The goal of this study was to carry out a meta-analysis and Trial Sequential Analysis (TSA) comparing the IABP versus pVAD (TandemHeart and the Impella) during high-risk percutaneous coronary intervention (PCI) or cardiogenic shock (CS). Using PubMed, Cochrane Central Register of Controlled Trials, and EMBASE we searched for randomized clinical trials (RCTs) and nonrandomized studies that compared pVAD versus IABP in patients who underwent high-risk PCI or with CS. We included 5 RCTs and 1 nonrandomized study comparing pVAD versus IABP. Based on the RCTs, we demonstrated no difference in short-term (6 months) (risk ratio [RR] 1.09, 95% confidence interval [CI] 0.79 to 1.52; p = 0.59) or long-term (12 months) (RR 1.00, 95% CI 0.57 to 1.76; p = 1.00) all-cause mortality. The use of pVAD seemed associated with more adverse events (acute kidney injury, limb ischemia, infection, major bleeding, and vascular injury) compared with IABP (RR 1.65, 95% CI 1.14 to 2.39; p = 0.008) but this was not supported by TSA (random-effects RR 1.66, 95% CI 0.89 to 3.09; p = 0.11; TSA-adjusted CI 0.13 to 21.3). In conclusion there were no differences in short or long-term mortality when using IABP versus pVAD for high-risk PCI or CS. IABP showed superiority over pVAD in terms of risk of harm. However, further RCTs are needed to establish more conclusively the role of these modalities of mechanical circulatory support during high-risk PCI or CS.