Elective intra-aortic balloon counterpulsation during high-risk percutaneous coronary intervention: a randomized controlled trial.
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.
Perera
Divaka
D
Cardiovascular Division, King's College London, London SE1 7EH, UK.
Stables
Rodney
R
Thomas
Martyn
M
Booth
Jean
J
Pitt
Michael
M
Blackman
Daniel
D
de Belder
Adam
A
Redwood
Simon
S
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