WAYNE, N.J., March 24, 2012 /PRNewswire/ --MAQUET, a global leader in medical systems, today 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 (PCI). Results from 51 months (mean) of follow up showed that elective IABP use during PCI was associated with a 34 percent reduction in all-cause mortality compared to patients who had no planned IABP insertion prior to PCI. The long-term data were presented in an oral session at the American College of Cardiology's 61st Annual Scientific Session in Chicago.
PCI 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 ischemia or arrhythmias that may occur during PCI and, thus, are at risk of cardiogenic shock or death. In these circumstances, vital hemodynamic 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 randomized, controlled, multicenter trial to assess the efficacy and safety of elective IABP use in patients undergoing high-risk PCI.
"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 PCI can be reduced by elective insertion of an IABP," said Divaka Perera, M.D., MRCP, 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 hemodynamic compromise, as evidenced by the frequent use of rescue IABP insertion in patients undergoing high-risk PCI 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 PCI in select patients with poor left ventricular function and extensive coronary disease."
Dr. 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 PCI. If the observed results translate to a real treatment effect, this would be of major importance as a 34 percent 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, randomized, controlled, multicenter BCIS-1 trial randomized 301 high-risk patients to either elective IABP use and PCI or no planned IABP use and PCI, with rescue IABP permitted. All patients had severe left ventricular dysfunction (i.e., an ejection fraction of <30 percent) and extensive coronary disease (i.e., a large amount of myocardium at risk). The primary endpoint, which was not met, was major adverse cardiac and cerebrovascular events (MACCE) at the time of hospital discharge or 28 days after PCI. The trial was conducted in 17 cardiac centers in the U.K. The follow-up study involved collecting mortality data for all study participants for up to six years. The primary endpoint of the follow-up study was all-cause mortality.
At a median follow-up of 51 months, elective IABP use during PCI was associated with a 34 percent 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 percent had procedural success as did 93 percent 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 a Johnson & Johnson company. The trial was powered to detect a specified difference in MACCE rather than all-cause mortality alone.
About MAQUET
As a trusted partner for hospitals and clinicians since 1838, Maquet is a global leader in medical systems that advance surgical interventions, cardiovascular procedures and critical care. Maquet develops and designs innovative products and therapeutic applications for the operating room, hybrid OR/Cath lab, intensive care unit and patient transport within acute care hospitals, improving outcomes and quality of life for patients.
Cardiovascular specialties include intra-aortic balloon counterpulsation therapy for cardiac assist; coronary artery bypass surgery; aortic and peripheral vascular surgery; and extracorporeal circulation.
The Critical Care portfolio includes market-leading intensive care ventilators and anesthesia machines.
Maquet also equips Surgical Workplaces with critical infrastructure such as flexible room design for OR and ICU; OR tables; lights and ceiling supply units; and OR integration for image data management.
Maquet is a subsidiary of the publicly listed Swedish Getinge Group. In 2011, Maquet generated nearly 1.4 billion Euro which is more than half of the Group's annual revenue of 2.4 billion Euros. The Getinge Group has 13,000 employees worldwide, including around 6,000 Maquet employees in 50 international sales and service organizations, as well as a network of more than 280 sales representatives. For more information please visit www.maquet.comand www.getingegroup.com.
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