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Published on: February 18, 2020
Long-term mortality data from the balloon pump-assisted coronary intervention study (BCIS-1): a randomized,
Divaka Perera1, Rod Stables, Tim Clayton
1Cardiovascular Division, St. Thomas' Hospital Campus, Kings College London, London SE1 7EH, UK. Divaka.Perera@kcl.ac.uk
Insights
Elective intra-aortic balloon pump (IABP) use during high-risk percutaneous coronary intervention (PCI) in patients with severe ischemic cardiomyopathy significantly reduced long-term all-cause mortality. This finding supports IABP as a beneficial intervention in this high-risk patient population.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Conflicting evidence exists regarding the utility of elective intra-aortic balloon pump (IABP) during high-risk percutaneous coronary intervention (PCI).
- Previous randomized trials have not supported IABP use, but observational studies suggested reduced in-hospital events.
- Limited long-term outcome data from randomized trials in this specific patient group were available.
Purpose of the Study:
- To evaluate the long-term impact of elective intra-aortic balloon pump (IABP) support during high-risk percutaneous coronary intervention (PCI) on all-cause mortality.
- To provide long-term outcome data from a randomized trial in patients with severe ischemic cardiomyopathy undergoing PCI.
Main Methods:
- A randomized controlled trial involving 301 patients with left ventricular impairment (ejection fraction <30%) and severe coronary disease (BCIS-1 jeopardy score ≥8).
- Patients were randomized to PCI with elective IABP support (n=151) or without planned IABP support (n=150).
- Long-term all-cause mortality was tracked via national death registries for a median of 51 months.
Main Results:
- The study included 301 patients with a mean ejection fraction of 23.6% and a mean jeopardy score of 10.4.
- At a median follow-up of 51 months, all-cause mortality was 33% in the overall cohort.
- Elective IABP use was associated with a significantly lower rate of all-cause mortality (42 deaths vs. 58 deaths; hazard ratio, 0.66; P=0.039).
Conclusions:
- In patients with severe ischemic cardiomyopathy undergoing PCI, elective IABP use was associated with a 34% relative reduction in long-term all-cause mortality.
- This study provides evidence supporting the long-term benefit of elective IABP use in high-risk PCI patients.
- The findings suggest a potential survival advantage for IABP in this specific clinical scenario.
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 after PCI, but there are currently no long-term outcome data from randomized trials in this setting.
Methods And Results:
Three hundred one patients with left ventricular impairment (ejection fraction <30%) and severe coronary disease (BCIS-1 jeopardy score ≥8; maximum possible score=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 (left ventricular ejection fraction, 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 (interquartile range, 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) (hazard ratio, 0.66; 95% confidence interval, 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 with unsupported PCI.
Clinical Trial Registration:
URL: http://www.isrctn.org. Unique identifier: ISRCTN40553718; and http://www.clinicaltrials.gov. Unique identifier: NCT00910481.
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