Maquet has announced positive long-term mortality results from the Balloon Pump-Assisted Coronary Intervention Study (BCIS-1), which evaluated the effect on major complications and mortality of elective use of an intra-aortic balloon pump (IABP) in patients with low ejection fraction undergoing high-risk percutaneous coronary intervention.
Results from 51 months (mean) of follow up showed that elective IABP use during percutaneous coronary intervention was associated with a 34% reduction in all-cause mortality compared to patients who had no planned IABP insertion prior to percutaneous coronary intervention. The long-term data were presented in an oral session at the American College of Cardiology’s 61st Annual Scientific Session in Chicago, USA.
Percutaneous coronary intervention in patients with impaired left ventricular function is associated with significant mortality and morbidity. These high-risk patients may not be able to withstand the consequences of ischaemia or arrhythmias that may occur during percutaneous coronary intervention and, thus, are at risk of cardiogenic shock or death. In these circumstances, vital haemodynamic support can be provided by an IABP, which works by increasing coronary flow and reducing the oxygen demand of the heart. As such, IABPs have been shown to be beneficial in situations such as cardiogenic shock, where there is low blood pressure and poor heart function. The BCIS-1 Study was the first randomised, controlled, multicentre trial to assess the efficacy and safety of elective IABP use in patients undergoing high-risk percutaneous coronary intervention.
“The BCIS-1 trial was a rigorously designed and conducted trial, and the long-term follow-up results are interesting because they appear to indicate that mortality following high-risk percutaneous coronary intervention can be reduced by elective insertion of an IABP,” said Divaka Perera, one of the principal investigators of the BCIS-1 trial, a consultant cardiologist at St Thomas’ Hospital in London and a senior lecturer at King’s College London. “These devices provide vital circulatory support in the event of haemodynamic compromise, as evidenced by the frequent use of rescue IABP insertion in patients undergoing high-risk percutaneous coronary intervention without planned counterpulsation. In addition, the lower long-term mortality found with elective IABP use may mean that prophylactic IABP insertion should be considered during percutaneous coronary intervention in select patients with poor left ventricular function and extensive coronary disease.”
Perera, who presented the long-term data at ACC 2012, added, “The BCIS-1 follow-up data demonstrate that these patients have a particularly high risk of death in the first few years after percutaneous coronary intervention. If the observed results translate to a real treatment effect, this would be of major importance as a 34% reduction in death amounts to a large absolute difference in mortality in a condition with a relatively poor long-term outcome.”
BCIS-1 trial design and results
The prospective, open, randomised, controlled, multicenter BCIS-1 trial randomised 301 high-risk patients to either elective IABP use and percutaneous coronary intervention or no planned IABP use and percutaneous coronary intervention, with rescue IABP permitted. All patients had severe left ventricular dysfunction (i.e., an ejection fraction of
At a median follow-up of 51 months, elective IABP use during percutaneous coronary intervention was associated with a 34% reduction in all-cause mortality compared to patients who had no planned IABP insertion prior to PCI (p=0.039). Among patients who had elective IABP, 94% had procedural success as did 93% of those with no planned IABP.
The BCIS-1 trial was sponsored by the British Cardiovascular Intervention Society with unrestricted educational grants from Maquet Cardiovascular and Cordis. The trial was powered to detect a specified difference in major adverse cardiac and cerebrovascular events rather than all-cause mortality alone.