JAMA Logo Physicians may subject high-risk patients to a coronary procedure like the placement of a stent. Prior to this procedure, a device known as an intra-aortic balloon pump is seemingly provided to such patients for enhancing blood flow. A recent study declares that the inclusion of this device before the procedure does not decrease the rate of events such as heart attack, revascularization or death.

Percutaneous coronary intervention (PCI) procedures like balloon angioplasty or stent placement are possibly recommended for opening narrowed coronary arteries. Experts believe that patients recommended to undergo PCI due to hampered left ventricular function face an elevated risk of illness or death. Also patients with extensive coronary artery disease with lower reserve to combat the consequences of ischemia or arrhythmias that supposedly occur during PCI may have a threat of illness or death.

Scientists elucidate, “In these circumstances, vital hemodynamic support can be provided by an intra-aortic balloon pump (IABP), a special pump connected to a balloon-type device that is inserted into the descending aorta), which simultaneously augments coronary blood flow and decreases myocardial oxygen demand. Observational studies have previously reported that elective IABP insertion may improve outcomes following high-risk PCI. To date, this assertion has not been tested in a randomized trial.”

In order to analyze the effectiveness and safety of elective IABP use in patients undergoing high-risk PCI, the authors commenced the Balloon Pump-Assisted Coronary Intervention Study (BCIS-1). Divaka Perera, M.D., M.R.C.P., of King’s College London, and colleagues initiated the randomized controlled trial between December 2005 and January 2009 in 17 tertiary referral cardiac centers in the United Kingdom. 301 study participants reported severe left ventricular dysfunction and extensive coronary disease. It was revealed that the primary outcome measure for such patients was major adverse cardiac and cardiovascular events (MACCE).

Investigators define MACCE as death, heart attack, cerebrovascular event, or further revascularization at hospital discharge of up to 28 days. The outcome of the study was that primary end point of MACCE at hospital discharge took place in 15.2 percent of the elective IABP group and 16.0 percent of the no planned IABP group. It was observed that all-cause mortality at 6 months in the elective IABP group was 4.6 percent and in the no planned IABP group was 7.4 percent.

Authors conclude, “The study did not demonstrate a difference in MACCE at hospital discharge and therefore does not support routine elective IABP insertion before high-risk PCI. However, 12 percent of patients who underwent PCI without elective IABP insertion required rescue IABP support, which highlights the importance of adopting a standby IABP strategy when undertaking high-risk PCI.”

Predefined procedural complications probably occurred in 16 patients forming 10.7 percent from the no planned IABP group. On the other hand, such complications were faced by 2 patients representing 1.3 percent from the group undergoing elective IABP insertion. Prolonged procedural hypotension which means an abnormally low blood pressure appeared as the most common component of these complications. This prolonged procedural hypotension seemingly occurred in 13 patients in the group with no planned IABP insertion and 2 patients in the group with elective IABP insertion.

19.2 percent of the elective IABP group and 11.3 percent of the no planned IABP group apparently suffered from either major or minor bleeding. No variation in the incidence of major bleeding may have taken place between the groups. While 5 patients from the elective IABP group underwent major bleeding, 6 patients from the no planned IABP group suffered from the same. Minor bleeding occurred in 15.9 percent of the elective IABP group and 7.3 percent belonging to the no planned IABP group.

The study was published in the August 25 issue of JAMA.