title: Elective intra-aortic balloon counterpulsation during high-risk percutaneous coronary intervention: a randomized controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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 < or = 30%) and extensive coronary disease (Jeopardy Score > or = 8/12); those with contraindications to or class I indications for IABP therapy were excluded.
  
  
  METHODS
  Elective insertion of IABP before PCI.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  isrctn.org Identifier: ISRCTN40553718; clinicaltrials.gov Identifier: NCT00910481.
authors.affiliation: Cardiovascular Division, King's College London, London SE1 7EH, UK.
authors.forename: Divaka
authors.initials: D
authors.lastname: Perera
authors.forename: Rodney
authors.initials: R
authors.lastname: Stables
authors.forename: Martyn
authors.initials: M
authors.lastname: Thomas
authors.forename: Jean
authors.initials: J
authors.lastname: Booth
authors.forename: Michael
authors.initials: M
authors.lastname: Pitt
authors.forename: Daniel
authors.initials: D
authors.lastname: Blackman
authors.forename: Adam
authors.initials: A
authors.lastname: de Belder
authors.forename: Simon
authors.initials: S
authors.lastname: Redwood
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D003324:Coronary Artery Disease / Q000628:therapy*; D005260:Female; D006801:Humans; D007423:Intra-Aortic Balloon Pumping / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D010351:Patient Discharge / Q000706:statistics & numerical data; D011446:Prospective Studies; D018570:Risk Assessment; D020521:Stroke / Q000209:etiology; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left