In patients with severe left ventricular dysfunction, PCI is associated with significant morbidity and mortality, particularly if large amounts of viable myocardium are supplied by the diseased coronary arteries. Although observational studies have suggested that intra-aortic balloon pump (IABP) insertion may decrease patient risk in this setting, no previous randomised controlled trial has examined this in detail.
The Balloon Pump-Assisted Coronary Intervention Study (BCIS-1) enrolled 301 patients with severe left ventricular dysfunction (<30%) and extensive coronary disease. Patients planned for elective PCI were randomised either to receive elective IABP insertion before PCI, or to have no planned IABP insertion. The main outcome measure was all major adverse cardiac and cardiovascular events (MACCE), defined as death, myocardial infarction, cerebrovascular event, or further revascularisation within 28 days of hospital discharge.
MACCE at hospital discharge occurred in 15.2% of patients with elective IABP insertion, and in 16.0% of those where IABP was not planned (p=0.85). Furthermore, no significant difference was seen in all-cause mortality at 6 months (4.6% vs 7.4%, p=0.32). Although there was a trend towards more major bleeding in patients with elective IABP insertion (19.2% vs 11.3%; p=0.06), and also access-site complications (3.3% vs 0%; p=0.06), this did not reach statistical significance; overall, fewer major procedural complications occurred with elective IABP insertion (1.3% vs 10.7%, p<0.001).
In this randomised trial, elective IABP insertion did not reduce the risk for MACCE after PCI in patients with a poor left ventricular ejection fraction and severe coronary artery disease. Routine use of an IABP in such cases is therefore not supported by these results.
▶ Perera D, Stables R, Thomas M, et al Elective intra-aortic balloon counterpulsation during high-risk percutaneous coronary intervention. JAMA 2010;304:867–74.