Elective Intra-aortic Balloon Counterpulsation During High-Risk Percutaneous Coronary Intervention: A Randomized Controlled Trial.

Link to article at PubMed

Elective Intra-aortic Balloon Counterpulsation During High-Risk Percutaneous Coronary Intervention: A Randomized Controlled Trial.

JAMA. 2010 Aug 25;304(8):867-874

Authors: Perera D, Stables R, Thomas M, Booth J, Pitt M, Blackman D, de Belder A, Redwood S,

CONTEXT: Observational studies have previously reported that elective intra-aortic balloon pump (IABP) insertion may improve outcomes following high-risk percutaneous coronary intervention (PCI). To date, this assertion has not been tested in a randomized trial. OBJECTIVE: To determine whether routine intra-aortic balloon counterpulsation before PCI reduces major adverse cardiac and cardiovascular events (MACCE) in patients with severe left ventricular dysfunction and extensive coronary disease. Design, Setting, and PATIENTS: The Balloon Pump-Assisted Coronary Intervention Study, a prospective, open, multicenter, randomized controlled trial conducted in 17 tertiary referral cardiac centers in the United Kingdom between December 2005 and January 2009. Patients (n = 301) had severe left ventricular dysfunction (ejection fraction </=30%) and extensive coronary disease (Jeopardy Score >/=8/12); those with contraindications to or class I indications for IABP therapy were excluded. INTERVENTION: Elective insertion of IABP before PCI. MAIN OUTCOME MEASURES: Primary end point was MACCE, defined as death, acute myocardial infarction, cerebrovascular event, or further revascularization at hospital discharge (capped at 28 days). Secondary end points included all-cause mortality at 6 months, major procedural complications, bleeding, and access-site complications. RESULTS: MACCE at hospital discharge occurred in 15.2% (23/151) of the elective IABP and 16.0% (24/150) of the no planned IABP groups (P = .85; odds ratio [OR], 0.94 [95% confidence interval {CI}, 0.51-1.76]). All-cause mortality at 6 months was 4.6% and 7.4% in the respective groups (P = .32; OR, 0.61 [95% CI, 0.24-1.62]). Fewer major procedural complications occurred with elective IABP insertion compared with no planned IABP use (1.3% vs 10.7%, P < .001; OR, 0.11 [95% CI, 0.01-0.49]). Major or minor bleeding occurred in 19.2% and 11.3% (P = .06; OR, 1.86 [95% CI, 0.93-3.79]) and access-site complications in 3.3% and 0% (P = .06) of the elective and no planned IABP groups, respectively. CONCLUSIONS: Elective IABP insertion did not reduce the incidence of MACCE following PCI. These results do not support a strategy of routine IABP placement before PCI in all patients with severe left ventricular dysfunction and extensive coronary disease. Trial Registration isrctn.org Identifier: ISRCTN40553718; clinicaltrials.gov Identifier: NCT00910481.

PMID: 20736470 [PubMed - as supplied by publisher]

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