"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.