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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 Percutaneous Coronary Intervention
Study Questions:
What is the long-term benefit of balloon pump support in high-risk percutaneous coronary intervention (PCI)?
Methods:
The authors reported the 1-year results of the BCIS-1 (Balloon-Pump Assisted Coronary Intervention Study) trial. In this trial, 301 patients with left ventricular (LV) impairment (ejection fraction [EF] <30%) and severe coronary disease (BCIS-1 jeopardy score ≥8) were randomized to receive PCI with elective intra-aortic balloon pump (IABP) support (n = 151) or without planned IABP support (n = 150). Long-term all-cause mortality was assessed using the Office of National Statistics (in England and Wales) and the General Register Office (in Scotland).
Results:
The mean LVEF was 23.6%. The mean BCIS-1 jeopardy score was 10.4, and the maximum jeopardy score of 12 was present in 46% of the cohort. Median follow-up was 51 months. All-cause mortality at follow-up was 33% in the overall cohort, with significantly fewer deaths occurring in the elective IABP group compared with the group that underwent PCI without planned IABP support (hazard ratio, 0.66; 95% confidence interval, 0.44-0.98; p = 0.039). Similar benefit was seen when the patients having procedural complications were excluded (hazard ratio, 0.64; 95% confidence interval, 0.42-0.96; p = 0.029).
Conclusions:
The authors concluded that among patients with a low EF and undergoing high-risk PCI, use of an IABP is associated with a reduction in long-term mortality.
Perspective:
The use of mechanical support is common among patients undergoing high-risk PCI, although there are limited randomized data to support such a strategy. BCIS was not designed to assess long-term survival, and these findings must be considered hypothesis generating. Currently, in absence of definitive data, the use of an IABP (or other mechanical support device) must be individualized for each patient with the recognition that long-term data from BCIS-1 suggest that there may be a possible long-term survival benefit from such a strategy.
Keywords: Elective Surgical Procedures, Coronary Angiography, Heart-Assist Devices, Coronary Disease, Confidence Intervals, Intra-Aortic Balloon Pumping, Pregnancy, Prolonged, Angioplasty, Balloon, Coronary, Percutaneous Coronary Intervention
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