title: Intracoronary versus intravenous bolus abciximab during primary percutaneous coronary intervention in patients with acute ST-elevation myocardial infarction: a randomised trial.
abstract: BACKGROUND
  Intracoronary administration of an abciximab bolus during a primary percutaneous coronary intervention results in a high local drug concentration, improved perfusion, and reduction of infarct size compared with intravenous bolus application. However, the safety and efficacy of intracoronary versus standard intravenous bolus application in patients with ST-elevation myocardial infarction (STEMI) undergoing this intervention has not been tested in a large-scale clinical trial.
  
  
  METHODS
  The AIDA STEMI trial was a randomised, open-label, multicentre trial. Patients presenting with STEMI in the previous 12 h with no contraindications for abciximab were randomly assigned in a 1:1 ratio by a central web-based randomisation system to intracoronary versus intravenous abciximab bolus (0·25 mg/kg bodyweight) during percutaneous coronary intervention with a subsequent 12 h intravenous infusion 0·125 μg/kg per min (maximum 10 μg/min). The primary endpoint was a composite of all-cause mortality, recurrent infarction, or new congestive heart failure within 90 days of randomisation. Secondary endpoints were the time to occurrence of the primary endpoint, each individual component of that endpoint, early ST-segment resolution, thrombolysis in myocardial infarction (TIMI) flow grade, and enzymatic infarct size. A masked central committee adjudicated the primary outcome and its components. Treatment allocation was not concealed from patients and investigators. This trial is registered with ClinicalTrials.gov, NCT00712101.
  
  
  RESULTS
  Between July, 2008, and April, 2011, 2065 patients were randomly assigned intracoronary abciximab (n=1032) or intravenous abciximab (n=1033). Intracoronary, as compared with intravenous abciximab, resulted in a similar rate of the primary composite clinical endpoint at 90 days in 1876 analysable patients (7·0%vs 7·6%; odds ratio [OR] 0·91; 95% CI 0·64-1·28; p=0·58). The incidence of death (4·5%vs 3·6%; 1·24; 0·78-1·97; p=0·36) and reinfarction (1·8%vs 1·8%; 1·0; 0·51-1·96; p=0·99) did not differ between the treatment groups, whereas less patients in the intracoronary group had new congestive heart failure (2·4%vs 4·1%; 0·57; 0·33-0·97; p=0·04). None of the secondary endpoints or safety measures differed significantly between groups.
  
  
  CONCLUSIONS
  In patients with STEMI undergoing primary percutaneous coronary intervention, intracoronary as compared to intravenous abciximab did not result in a difference in the combined endpoint of death, reinfarction, or congestive heart failure. Since intracoronary abciximab bolus administration is safe and might be related to reduced rates of congestive heart failure the intracoronary route might be preferred if abciximab is indicated.
  
  
  BACKGROUND
  Lilly, Germany. University of Leipzig-Heart Centre. University of Leipzig, Clinical Trial Centre Leipzig, supported by the Federal Ministry of Education and Research (BMBF).
authors.affiliation: Universität Leipzig-Heart Centre, Department of Internal Medicine-Cardiology, Leipzig, Germany. Electronic address: thielh@medizin.uni-leipzig.de.
authors.forename: Holger
authors.initials: H
authors.lastname: Thiele
authors.affiliation: University of Ulm, Department of Internal Medicine-Cardiology, Ulm, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Wöhrle
authors.affiliation: Klinikum Links der Weser, Bremen, Germany.
authors.forename: Rainer
authors.initials: R
authors.lastname: Hambrecht
authors.affiliation: Klinikum Coburg, Coburg, Germany.
authors.forename: Harald
authors.initials: H
authors.lastname: Rittger
authors.affiliation: Schwarzwald-Baar Klinikum Villingen-Schwenningen, Villingen-Schwenningen, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Birkemeyer
authors.affiliation: Zentralklinik Bad Berka, Bad Berka, Germany.
authors.forename: Bernward
authors.initials: B
authors.lastname: Lauer
authors.affiliation: University Leipzig-Clinical Trial Centre, Leipzig, Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Neuhaus
authors.affiliation: University Leipzig-Clinical Trial Centre, Leipzig, Germany.
authors.forename: Oana
authors.initials: O
authors.lastname: Brosteanu
authors.affiliation: Krankenhaus der Barmherzigen Brüder, Regensburg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Sick
authors.affiliation: Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen, Germany.
authors.forename: Marcus
authors.initials: M
authors.lastname: Wiemer
authors.affiliation: Herz- und Gefäß-Klinik, Bad Neustadt, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Kerber
authors.affiliation: Ambulantes Herzzentrum Chemnitz, Chemnitz, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Kleinertz
authors.affiliation: Universität Leipzig-Heart Centre, Department of Internal Medicine-Cardiology, Leipzig, Germany.
authors.forename: Ingo
authors.initials: I
authors.lastname: Eitel
authors.affiliation: Universität Leipzig-Heart Centre, Department of Internal Medicine-Cardiology, Leipzig, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Desch
authors.affiliation: Universität Leipzig-Heart Centre, Department of Internal Medicine-Cardiology, Leipzig, Germany.
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*; D003331:Coronary Vessels; D004562:Electrocardiography; 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 / Q000628:therapy*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D015607:Stents
chemical_list: D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D000077284:Abciximab