We conducted the IABP Cardiogenic Shock Trial (ClinicalTrials.gov ID NCT00469248) as a prospective, randomized, monocentric clinical trial to determine the hemodynamic effects of additional intra-aortic balloon pump (IABP) treatment and its effects on severity of disease in patients with acute myocardial infarction complicated by cardiogenic shock (CS). Intra-aortic balloon pump counterpulsation is recommended in patients with CS complicating myocardial infarction. However, there are only limited randomized controlled trial data available supporting the efficacy of IABP following percutaneous coronary intervention (PCI) and its impact on hemodynamic parameters in patients with CS. Percutaneous coronary intervention of infarct-related artery was performed in 40 patients with acute myocardial infarction complicated by CS, within 12 h of onset of hemodynamic instability. Serial hemodynamic parameters were determined over the next 4 days and compared in patients receiving medical treatment alone with those treated with additional intra-aortic balloon counterpulsation. There were no significant differences among severity of disease (i.e., Acute Physiology and Chronic Health Evaluation II score) initially and no differences among both groups for disease improvement. We observed significant temporal improvements of cardiac output (4.8 ± 0.5 to 6.0 ± 0.5 L/min), systemic vascular resistance (926 ± 73 to 769 ± 101 dyn · s−1 · cm−5), and the prognosis-validated cardiac power output (0.78 ± 0.06 to 1.01 ± 0.2 W) within the IABP group. However, there were no significant differences between the IABP group and the medical-alone group. Additional IABP treatment did not result in a significant hemodynamic improvement compared with medical therapy alone in a randomized prospective trial in patients with CS following PCI. Therefore, the use and recommendation for IABP treatment in CS remain unclear.
ABBREVIATIONS: AMI—acute myocardial infarction
CPi—cardiac power index
CPO—cardiac power output
IABP—intra-aortic balloon pump
LVSWI—left ventricular stroke work index
MAP—mean arterial blood pressure
PCI—percutaneous coronary intervention
PCWP—pulmonary capillary wedge pressure
STEMI—ST-elevation myocardial infarction
SVR—systemic vascular resistance
*Department of Medicine III and †Department of Biometrics and Statistics, Martin Luther University, Halle-Wittenberg, Halle/Saale, Germany
Address reprint requests to Michael Buerke, MD, Department of Medicine III, Martin Luther University, Ernst-Grube-Strasse 40, 06097 Halle/Saale, Germany. E-mail: email@example.com.
The authors declare that the study was supported by an unrestricted grant from Datascope.
Received September 12, 2011
Accepted January 5, 2012