title: Intracoronary compared with intravenous bolus abciximab application during primary percutaneous coronary intervention: design and rationale of the Abciximab Intracoronary versus intravenously Drug Application in ST-Elevation Myocardial Infarction (AIDA STEMI) trial.
abstract: BACKGROUND
  Intravenous abciximab reduces major adverse cardiac events in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Intracoronary abciximab bolus application during PCI results in high local drug concentration, improved perfusion, reduction of infarct size, and less microvascular obstruction. The hypothesis of this trial is that abciximab bolus intracoronary in comparison to standard intravenous application will improve the outcome of patients undergoing primary PCI in STEMI.
  
  
  METHODS
  The Abciximab Intracoronary versus intravenously Drug Application in STEMI (AIDA STEMI) study is a 1,912-patient, prospective, multicenter, randomized, open-label, controlled trial. The study is designed to compare the efficacy and safety of intracoronary versus intravenous bolus abciximab administration during primary PCI with subsequent intravenous infusion for 12 hours. Patients will be randomized in a 1:1 fashion to 1 of the 2 treatments. The primary efficacy end point of AIDA STEMI is the composite of all-cause mortality, recurrent MI, or new congestive heart failure within 90 days of randomization. The primary safety outcome assessment will be major bleeding.
  
  
  CONCLUSIONS
  The AIDA STEMI study addresses important questions regarding the efficacy and safety of intracoronary abciximab bolus administration during primary PCI in patients with STEMI, potentially optimizing the route of administration of glycoprotein IIb/IIIa inhibitors in the catheterization laboratory.
authors.affiliation: Universität Leipzig-Heart Center, Department of Internal Medicine-Cardiology, Germany. thielh@medizin.uni-leipzig.de
authors.forename: Holger
authors.initials: H
authors.lastname: Thiele
authors.forename: Jochen
authors.initials: J
authors.lastname: Wöhrle
authors.forename: Petra
authors.initials: P
authors.lastname: Neuhaus
authors.forename: Oana
authors.initials: O
authors.lastname: Brosteanu
authors.forename: Peter
authors.initials: P
authors.lastname: Sick
authors.forename: Roland
authors.initials: R
authors.lastname: Prondzinsky
authors.forename: Ralf
authors.initials: R
authors.lastname: Birkemeyer
authors.forename: Marcus
authors.initials: M
authors.lastname: Wiemer
authors.forename: Sebastian
authors.initials: S
authors.lastname: Kerber
authors.forename: Helmut
authors.initials: H
authors.lastname: Schuehlen
authors.forename: Klaus
authors.initials: K
authors.lastname: Kleinertz
authors.forename: Christoph
authors.initials: C
authors.lastname: Axthelm
authors.forename: Rainer
authors.initials: R
authors.lastname: Zimmermann
authors.forename: Harald
authors.initials: H
authors.lastname: Rittger
authors.forename: Rüdiger C
authors.initials: RC
authors.lastname: Braun-Dullaeus
authors.forename: Bernward
authors.initials: B
authors.lastname: Lauer
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Burckhardt
authors.forename: Markus
authors.initials: M
authors.lastname: Ferrari
authors.forename: Martin W
authors.initials: MW
authors.lastname: Bergmann
authors.forename: Rainer
authors.initials: R
authors.lastname: Hambrecht
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
mesh_terms: D000077284:Abciximab; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage*; D007269:Injections, Intra-Arterial; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy / Q000628:therapy*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D000077284:Abciximab