Intra-aortic balloon pumps (IABPs) are commonly used to reduce the likelihood of complications in stable high-risk patients undergoing percutaneous coronary intervention (PCI). Investigators for the randomized controlled Balloon Pump–Assisted Coronary Intervention Study evaluated this practice in 301 patients (mean age, 71; 80% men) with left ventricular (LV) ejection fractions of 30% and a large amount of myocardium at risk. The investigators excluded patients who fulfill American College of Cardiology/American Heart Association Class I and II recommendations for IABP use: cardiogenic shock, acute myocardial infarction (AMI) within 48 hours before scheduled PCI, or complications of AMI requiring circulatory support. The primary endpoint was the composite of death, AMI, stroke, or further revascularization before hospital discharge.

Twelve percent of patients assigned to no planned IABP underwent rescue IABP insertion. A primary endpoint occurred in 15% of the IABP group and in 16% of the no-planned–IABP group. Three deaths occurred in the IABP group compared with one death in the no-planned–IABP group. MI occurred in about 13% of each group. Two strokes occurred in the IABP group and none in the no-planned–IABP group. Predefined procedural complications (primarily hypotension) were less frequent in the IABP group than in the no-planned–IABP group (1% vs. 11%). However, bleeding was more common in the IABP group (19% vs. 11%), as were access-site complications (3% vs. 0%).

Comment: This trial failed to demonstrate a benefit of elective IABP use in stable high-risk patients undergoing PCI. The results are not definitive; importantly, patients with a Class I or II indication for the device were excluded, and the guideline recommendation for hemodynamic support in these highest-risk patients remains unchallenged. Nonetheless, these findings not only call into question the merits of routine IABP placement in patients with severe LV dysfunction and extensive coronary disease, they also illustrate the importance of testing such “common-sense” strategies in clinical trials.

Published in Journal Watch Cardiology August 25, 2010