title: Intra-aortic balloon counterpulsation and infarct size in patients with acute anterior myocardial infarction without shock: the CRISP AMI randomized trial.
abstract: BACKGROUND
  Intra-aortic balloon counterpulsation (IABC) is an adjunct to revascularization in patients with cardiogenic shock and reduces infarct size when placed prior to reperfusion in animal models.
  
  
  OBJECTIVE
  To determine if routine IABC placement prior to reperfusion in patients with anterior ST-segment elevation myocardial infarction (STEMI) without shock reduces myocardial infarct size.
  
  
  METHODS
  An open, multicenter, randomized controlled trial, the Counterpulsation to Reduce Infarct Size Pre-PCI Acute Myocardial Infarction (CRISP AMI) included 337 patients with acute anterior STEMI but without cardiogenic shock at 30 sites in 9 countries from June 2009 through February 2011.
  
  
  METHODS
  Initiation of IABC before primary percutaneous coronary intervention (PCI) and continuation for at least 12 hours (IABC plus PCI) vs primary PCI alone.
  
  
  METHODS
  Infarct size expressed as a percentage of left ventricular (LV) mass and measured by cardiac magnetic resonance imaging performed 3 to 5 days after PCI. Secondary end points included all-cause death at 6 months and vascular complications and major bleeding at 30 days. Multiple imputations were performed for missing infarct size data.
  
  
  RESULTS
  The median time from first contact to first coronary device was 77 minutes (interquartile range, 53 to 114 minutes) for the IABC plus PCI group vs 68 minutes (interquartile range, 40 to 100 minutes) for the PCI alone group (P = .04). The mean infarct size was not significantly different between the patients in the IABC plus PCI group and in the PCI alone group (42.1% [95% CI, 38.7% to 45.6%] vs 37.5% [95% CI, 34.3% to 40.8%], respectively; difference of 4.6% [95% CI, -0.2% to 9.4%], P = .06; imputed difference of 4.5% [95% CI, -0.3% to 9.3%], P = .07) and in patients with proximal left anterior descending Thrombolysis in Myocardial Infarction flow scores of 0 or 1 (46.7% [95% CI, 42.8% to 50.6%] vs 42.3% [95% CI, 38.6% to 45.9%], respectively; difference of 4.4% [95% CI, -1.0% to 9.7%], P = .11; imputed difference of 4.8% [95% CI, -0.6% to 10.1%], P = .08). At 30 days, there were no significant differences between the IABC plus PCI group and the PCI alone group for major vascular complications (n = 7 [4.3%; 95% CI, 1.8% to 8.8%] vs n = 2 [1.1%; 95% CI, 0.1% to 4.0%], respectively; P = .09) and major bleeding or transfusions (n = 5 [3.1%; 95% CI, 1.0% to 7.1%] vs n = 3 [1.7%; 95% CI, 0.4% to 4.9%]; P = .49). By 6 months, 3 patients (1.9%; 95% CI, 0.6% to 5.7%) in the IABC plus PCI group and 9 patients (5.2%; 95% CI, 2.7% to 9.7%) in the PCI alone group had died (P = .12).
  
  
  CONCLUSIONS
  Among patients with acute anterior STEMI without shock, IABC plus primary PCI compared with PCI alone did not result in reduced infarct size.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00833612.
authors: Division of Cardiology, Department of Medicine, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina 27715, USA. manesh.patel@duke.edu
authors: Manesh R
authors: MR
authors: Patel
authors: Richard W
authors: RW
authors: Smalling
authors: Holger
authors: H
authors: Thiele
authors: Huiman X
authors: HX
authors: Barnhart
authors: Yi
authors: Y
authors: Zhou
authors: Praveen
authors: P
authors: Chandra
authors: Derek
authors: D
authors: Chew
authors: Marc
authors: M
authors: Cohen
authors: John
authors: J
authors: French
authors: Divaka
authors: D
authors: Perera
authors: E Magnus
authors: EM
authors: Ohman
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon; D005260:Female; D006352:Heart Ventricles; D006801:Humans; D007423:Intra-Aortic Balloon Pumping / Q000379:methods*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000145:classification / Q000473:pathology / Q000628:therapy*; D015425:Myocardial Reperfusion; D012770:Shock, Cardiogenic; D016896:Treatment Outcome