Prophylactic counterpulsation with an intra-aortic balloon pump did not prevent major adverse cardiovascular events from developing in high-risk PCI patients, according to a randomized study of 294 patients in the United Kingdom.
In what they described as the first randomized controlled trial to assess the efficacy and safety of the prophylactic use of an IABP in patients at high risk due to severe left ventricular impairment and extensive coronary disease, investigators found no difference in cardiovascular events between patients randomly assigned to planned IABP counterpulsation and those assigned to no planned IABP counterpulsation before PCI.
In addition, “elective IABP use was associated with significantly fewer procedural complications but more minor bleeding and more access-site complications than when PCI was performed without planned IABP insertion,” said Dr. Divaka Perera of King's College, London, and his associates.
They performed the prospective, open-label trial at 17 interventional cardiology centers in the United Kingdom in 2005-2009. The study involved 294 patients with multivessel disease, impaired left ventricular function, and a large amount of myocardium subtended by stenosed vessels who were scheduled for PCI of either native coronary arteries or bypass grafts.
A total of 147 patients underwent IABP insertion before PCI and 147 had no IABP insertion unless the need for counterpulsation developed during PCI. All the subjects were followed until hospital discharge or for 28 days following the procedure.
Of the 147 patients in the control group who did not receive prophylactic IABP, 18 (12%) required rescue IABP counterpulsation during PCI, usually because they developed prolonged hypotension during the procedure (13 cases).
The primary end point of major adverse cardiac or cardiovascular events (MACCE) within 28 days occurred in 15% of the patients who had prophylactic placement of an IABP and 16% of those who did not, a nonsignificant difference. There was a 2.8% absolute decrease in mortality at 6 months with prophylactic IABP counterpulsation, but that difference also was nonsignificant, according to the researchers (JAMA 2010;304;867-74).
The MACCE rates also did not differ significantly in important subgroups of patients, including those who had impaired kidney function, diabetes, or extremely high risk of PCI-related complications.
Major procedural complications occurred less often in the group with prophylactic IABP (1.3%) than in the control group (10.7%), but bleeding events and access-site complications were more frequent with prophylactic IABP (19.2% vs. 11.3% and 3.3% vs. 0%, respectively).
“These results do not support a strategy of prophylactic placement of an intra-aortic balloon catheter during PCI in all patients with severe left ventricular dysfunction” and a high risk of PCI-related complications, Dr. Perera and his associates said.
Disclosures: The study was sponsored by the British Cardiovascular Intervention Society, funded by Maquet Cardiovascular, Cordis, and Johnson & Johnson, and was supported in part by Lilly. Dr. Perera and an associate received financial support from the U.K. Department of Health.