title: Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial.
abstract: BACKGROUND
  Thrombus embolization during percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) is common and results in suboptimal myocardial perfusion and increased infarct size. Two strategies proposed to reduce distal embolization and improve outcomes after primary PCI are bolus intracoronary abciximab and manual aspiration thrombectomy.
  
  
  OBJECTIVE
  To determine whether bolus intracoronary abciximab, manual aspiration thrombectomy, or both reduce infarct size in high-risk patients with STEMI.
  
  
  METHODS
  Between November 28, 2009, and December 2, 2011, 452 patients presenting at 37 sites in 6 countries within 4 hours of STEMI due to proximal or mid left anterior descending artery occlusion undergoing primary PCI with bivalirudin anticoagulation were randomized in an open-label, 2 x 2 factorial design to bolus intracoronary abciximab delivered locally at the infarct lesion site vs no abciximab and to manual aspiration thrombectomy vs no thrombectomy.
  
  
  METHODS
  A 0.25-mg/kg bolus of abciximab was administered at the site of the infarct lesion via a local drug delivery catheter. Manual aspiration thrombectomy was performed with a 6 F aspiration catheter.
  
  
  METHODS
  Primary end point: infarct size (percentage of total left ventricular mass) at 30 days assessed by cardiac magnetic resonance imaging (cMRI) in the abciximab vs no abciximab groups (pooled across the aspiration randomization); major secondary end point: 30-day infarct size in the aspiration vs no aspiration groups (pooled across the abciximab randomization).
  
  
  RESULTS
  Evaluable cMRI results at 30 days were present in 181 and 172 patients randomized to intracoronary abciximab vs no abciximab, respectively, and in 174 and 179 patients randomized to manual aspiration vs no aspiration, respectively. Patients randomized to intracoronary abciximab compared with no abciximab had a significant reduction in 30-day infarct size (median, 15.1%; interquartile range [IQR], 6.8%-22.7%; n = 181, vs 17.9% [IQR, 10.3%-25.4%]; n = 172; P = .03). Patients randomized to intracoronary abciximab also had a significant reduction in absolute infarct mass (median, 18.7 g [IQR, 7.4-31.3 g]; n = 184, vs 24.0 g [IQR, 12.1-34.2 g]; n = 175; P = .03) but not abnormal wall motion score (median, 7.0 [IQR, 2.0-10.0]; n = 188, vs 8.0 [IQR, 3.0-10.0]; n = 184; P = .08). Patients randomized to aspiration thrombectomy vs no aspiration had no significant difference in infarct size at 30 days (median, 17.0% [IQR, 9.0%-22.8%]; n = 174, vs 17.3% [IQR, 7.1%-25.5%]; n = 179; P = .51), absolute infarct mass (median, 20.3 g [IQR, 9.7-31.7 g]; n = 178, vs 21.0 g [IQR, 9.1-34.1 g]; n = 181; P = .36), or abnormal wall motion score (median, 7.5 [IQR, 2.0-10.0]; n = 186, vs 7.5 [IQR, 2.0-10.0]; n = 186; P = .89).
  
  
  CONCLUSIONS
  In patients with large anterior STEMI presenting early after symptom onset and undergoing primary PCI with bivalirudin anticoagulation, infarct size at 30 days was significantly reduced by bolus intracoronary abciximab delivered to the infarct lesion site but not by manual aspiration thrombectomy.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00976521.
authors.affiliation: Columbia University Medical Center and New York–Presbyterian Hospital, New York, New York 10022, USA. gs2184@columbia.edu
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Akiko
authors.initials: A
authors.lastname: Maehara
authors.forename: Bernhard
authors.initials: B
authors.lastname: Witzenbichler
authors.forename: Jacek
authors.initials: J
authors.lastname: Godlewski
authors.forename: Helen
authors.initials: H
authors.lastname: Parise
authors.forename: Jan-Henk E
authors.initials: JH
authors.lastname: Dambrink
authors.forename: Andrzej
authors.initials: A
authors.lastname: Ochala
authors.forename: Trevor W
authors.initials: TW
authors.lastname: Carlton
authors.forename: Ecaterina
authors.initials: E
authors.lastname: Cristea
authors.forename: Steven D
authors.initials: SD
authors.lastname: Wolff
authors.forename: Sorin J
authors.initials: SJ
authors.lastname: Brener
authors.forename: Saqib
authors.initials: S
authors.lastname: Chowdhary
authors.forename: Magdi
authors.initials: M
authors.lastname: El-Omar
authors.forename: Thomas
authors.initials: T
authors.lastname: Neunteufl
authors.forename: D Christopher
authors.initials: DC
authors.lastname: Metzger
authors.forename: Theodore
authors.initials: T
authors.lastname: Karwoski
authors.forename: Jose M
authors.initials: JM
authors.lastname: Dizon
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
mesh_terms: D000077284:Abciximab; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D003331:Coronary Vessels; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000473:pathology*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D011446:Prospective Studies; D017131:Thrombectomy / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D000077284:Abciximab