Long-Term Mortality Data from the Balloon-Pump Assisted Coronary Intervention Study (BCIS-1): A Randomized Controlled Trial of Elective Balloon Counterpulsation during High-Risk PCI
Background—There is conflicting evidence on the utility of elective intra-aortic balloon pump (IABP) use during high-risk percutaneous coronary intervention (PCI). Observational series have indicated a reduction in major in-hospital adverse events although randomized trial evidence does not support this. A recent study has suggested a mortality benefit trend early following PCI but there is currently no long-term outcome data from randomized trials in this setting.
Methods and Results—301 patients with left ventricular impairment (ejection fraction <30%) and severe coronary disease (BCIS1 Jeopardy Score ≥ 8, where maximum possible=12) were randomized to receive PCI with elective IABP support (n=151) or without planned IABP support (n=150). Long-term all-cause mortality was assessed by tracking the databases held at the Office of National Statistics (in England and Wales) and the General Register Office (in Scotland). The groups were balanced in terms of baseline characteristics (LVEF 23.6%, BCIS-1 Jeopardy score 10.4) and the amount and type of revascularization performed. Mortality data were available for the entire cohort at a median of 51 months (IQR 41, 58) from randomization. All-cause mortality at follow-up was 33% in the overall cohort with significantly fewer deaths occurring in the Elective IABP group (n=42) than in the group that underwent PCI without planned IABP support (n=58) (HR 0.66, 95% CI: 0.44 – 0.98, p=0.039).
Conclusions—In patients with severe ischemic cardiomyopathy treated with PCI, all-cause mortality was 33% at a median of 51 months. Elective IABP use during PCI was associated with a 34% relative reduction in all-cause mortality, compared to unsupported PCI.
- high-risk populations
- intra-aortic balloon pump
- ischemic cardiomyopathy
- percutaneous coronary intervention
- Received July 19, 2012.
- Accepted November 2, 2012.
- Copyright © 2012, American Heart Association, Inc. All rights reserved. Unauthorized use prohibited