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Updated: Jun 18, 2026
The Intra-Aortic Balloon Pump
Published on: February 5, 2021
The balloon pump-assisted coronary intervention study (BCIS-1): rationale and design
Divaka Perera1, Rodney Stables, Jean Booth
1Cardiovascular Division, Rayne Institute, St Thomas' Hospital, London SE1 7EH, United Kingdom.
Insights
Elective intra-aortic balloon pump (IABP) use before high-risk percutaneous coronary intervention (PCI) was tested in the BCIS-1 randomized trial. The study aimed to determine if IABP reduces major adverse cardiac and cerebrovascular events (MACCEs).
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Observational studies suggest intra-aortic balloon pump (IABP) insertion may reduce complications in high-risk percutaneous coronary intervention (PCI).
- Current international guidelines lack formal recommendations for elective IABP use in high-risk PCI due to a lack of randomized trial data.
- High-risk PCI is often defined by severe left ventricular dysfunction and significant myocardium at risk.
Purpose of the Study:
- To test the hypothesis that elective IABP insertion before high-risk PCI reduces major adverse cardiac and cerebrovascular events (MACCEs).
- To provide evidence to inform international guidelines regarding IABP use in high-risk PCI.
- To clarify the role of elective IABP support in patients undergoing high-risk PCI.
Main Methods:
- The BCIS-1 trial is a randomized study involving 300 eligible patients.
- Patients were randomized to receive either elective IABP insertion or no planned IABP insertion.
- Exclusion criteria included cardiogenic shock, class I IABP indication, or absolute contraindications to IABP.
Main Results:
- The study's primary outcome is MACCEs at hospital discharge or 28 days post-PCI.
- Results are anticipated to define the efficacy of elective IABP in high-risk PCI patients.
- Findings will guide potential revisions of current international guidelines.
Conclusions:
- The BCIS-1 trial is expected to provide definitive evidence on the utility of elective IABP in high-risk PCI.
- Positive findings could lead to updated guidelines and increased adoption of IABP support.
- Neutral or negative results would support the current restricted guideline recommendations and rationalize observed clinical practice.
Abstract:
Several observational studies have suggested that mortality and major complications after high-risk percutaneous coronary intervention (PCI) can be reduced by elective insertion of an intra-aortic balloon pump (IABP). However, to date, this assertion has never been tested in a randomized trial, and as such, international guidelines do not provide formal recommendations for IABP use in this setting. The BCIS-1 is a randomized trial that addresses the hypothesis that elective IABP insertion before high-risk PCI will reduce major adverse cardiac and cerebrovascular events (MACCEs) at hospital discharge or 28 days after index PCI, whichever occurs sooner. High risk is defined by the presence of severe left ventricular dysfunction as well as a large amount of myocardium at risk. Patients who are in cardiogenic shock, have a class I indication for IABP use, or have an absolute contraindication to IABP use will be excluded. Three hundred eligible patients will be randomized to receive elective IABP insertion or no planned IABP insertion. The findings of BCIS-1 are expected to define the role of balloon counterpulsation in high-risk PCI. Confirmation of the efficacy of elective IABP use may prompt review of the international guidelines, which are currently very restricted. In contrast, a neutral or adverse outcome with elective counterpulsation in these high-risk patients will allow evidence-based rationalization of the current disparity between guidelines and the frequent real-world use of elective IABP support.
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