Elective intra-aortic balloon counterpulsation during high-risk percutaneous coronary intervention: a randomized

Divaka Perera1, Rodney Stables, Martyn Thomas

  • 1Cardiovascular Division, King's College London, London SE1 7EH, UK.

JAMA
|August 26, 2010
PubMed

Insights

Routine intra-aortic balloon pump (IABP) insertion before high-risk percutaneous coronary intervention (PCI) did not reduce major adverse cardiac events. This randomized trial found no benefit, questioning the routine use of IABP in such patients.

Area of Science:

  • Cardiology
  • Interventional Cardiology
  • Clinical Trials

Background:

  • Observational studies suggested elective intra-aortic balloon pump (IABP) insertion may improve outcomes after high-risk percutaneous coronary intervention (PCI).
  • No randomized trial had previously validated this assertion.
  • This study aimed to rigorously test the efficacy of routine IABP use in a specific high-risk patient group.

Purpose of the Study:

  • To determine if routine intra-aortic balloon counterpulsation before PCI reduces major adverse cardiac and cardiovascular events (MACCE).
  • To assess the impact of IABP on MACCE in patients with severe left ventricular dysfunction and extensive coronary disease.

Main Methods:

  • A prospective, open-label, multicenter, randomized controlled trial (Balloon Pump-Assisted Coronary Intervention Study).
  • 301 patients with ejection fraction ≤30% and Jeopardy Score ≥8/12 were randomized.
  • Patients received either elective IABP insertion before PCI or no planned IABP.

Main Results:

  • No significant difference in MACCE at hospital discharge between the elective IABP group (15.2%) and the no planned IABP group (16.0%; P=.85).
  • All-cause mortality at 6 months was similar (4.6% vs 7.4%; P=.32).
  • Major procedural complications were significantly lower with elective IABP (1.3% vs 10.7%; P<.001), but bleeding and access-site complications showed non-significant trends towards increase.

Conclusions:

  • Elective IABP insertion did not reduce MACCE in patients undergoing high-risk PCI.
  • The findings do not support routine IABP placement for all patients with severe left ventricular dysfunction and extensive coronary disease.
  • While IABP reduced procedural complications, the lack of overall outcome benefit makes its routine use questionable.
Abstract