Use of an increasingly common percutaneous coronary intervention of inserting an intra-aortic balloon pump (IABP) to improve blood flow prior to patients undergoing stent placement did not lower rates of repeat procedures, heart attacks or death, said London researchers who conducted a randomized trial of the device in 301 patients who underwent the elective procedure.
"The study did not demonstrate a difference in major adverse cardiac and cardiovascular events (MACCE) at hospital discharge, and therefore does not support routine elective IABP insertion before high-risk percutaneous coronary intervention," concluded the authors, affiliated with King's College and several other institutions in the United Kingdom.
The study was published in this week's issue of the Journal of the American Medical Association.
The reason to use these pumps was that in some patients with severely impaired left ventricular function, insertion of a stent can increase risk of illness and death. They may not be able to withstand consequences of ischemia or arrhythmias that may occur during the procedure.
The idea was that these pumps could provide hemodynamic support through a special pump connected to a balloon-type device inserted into the descending aorta.
"Observational studies have previously reported that elective IABP insertion may improve outcomes following high-risk PCI," but the assertion had not been tested in a randomized clinical trial.
What the researchers discovered after randomizing similar patients to receive the pump or not.
At the end of the study, which was the patient's discharge from the hospital, death, heart attack, a cerebrovascular event or further revascularization procedure occurred in 15.2% of the elective IABP group and 16% of the group that did not have the IABP.
All cause mortality at six months was 4.6% in the treated group, versus 7.4%. Major or minor bleeding occurred in 19.2% of the elective IABP group, but 11.3% of the control group. Use of the device in the pre-stented group, however, did appear to reduce surgical complications.
One important caveat the researchers emphasized is that 12% of the patients in the control group, who did not have planned elective IABP insertion, required the procedure as a rescue strategy, "which highlights the importance of adopting a standby IABP strategy when undertaking high-risk PCI," the authors wrote.