title: Abciximab and heparin versus bivalirudin for non-ST-elevation myocardial infarction.
abstract: BACKGROUND
  The combination of glycoprotein IIb/IIIa inhibitors and heparin has not been compared with bivalirudin in studies specifically involving patients with non-ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI). We compared the two treatments in this patient population.
  
  
  METHODS
  Immediately before PCI, we randomly assigned, in a double-blind manner, 1721 patients with acute non-ST-segment elevation myocardial infarction to receive abciximab plus unfractionated heparin (861 patients) or bivalirudin (860 patients). The study tested the hypothesis that abciximab and heparin would be superior to bivalirudin with respect to the primary composite end point of death, large recurrent myocardial infarction, urgent target-vessel revascularization, or major bleeding within 30 days. Secondary end points included the composite of death, any recurrent myocardial infarction, or urgent target-vessel revascularization (efficacy end point) and major bleeding (safety end point) within 30 days.
  
  
  RESULTS
  The primary end point occurred in 10.9% of the patients in the abciximab group (94 patients) and in 11.0% in the bivalirudin group (95 patients) (relative risk with abciximab, 0.99; 95% confidence interval [CI], 0.74 to 1.32; P=0.94). Death, any recurrent myocardial infarction, or urgent target-vessel revascularization occurred in 12.8% of the patients in the abciximab group (110 patients) and in 13.4% in the bivalirudin group (115 patients) (relative risk, 0.96; 95% CI, 0.74 to 1.25; P=0.76). Major bleeding occurred in 4.6% of the patients in the abciximab group (40 patients) as compared with 2.6% in the bivalirudin group (22 patients) (relative risk, 1.84; 95% CI, 1.10 to 3.07; P=0.02).
  
  
  CONCLUSIONS
  Abciximab and unfractionated heparin, as compared with bivalirudin, failed to reduce the rate of the primary end point and increased the risk of bleeding among patients with non-ST-segment elevation myocardial infarction who were undergoing PCI. (Funded by Nycomed Pharma and others; ISAR-REACT 4 ClinicalTrials.gov number, NCT00373451.).
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany. kastrati@dhm.mhn.de
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Stefanie
authors.initials: S
authors.lastname: Schulz
authors.forename: Steffen
authors.initials: S
authors.lastname: Massberg
authors.forename: Robert A
authors.initials: RA
authors.lastname: Byrne
authors.forename: Miroslaw
authors.initials: M
authors.lastname: Ferenc
authors.forename: Karl-Ludwig
authors.initials: KL
authors.lastname: Laugwitz
authors.forename: Jürgen
authors.initials: J
authors.lastname: Pache
authors.forename: Ilka
authors.initials: I
authors.lastname: Ott
authors.forename: Jörg
authors.initials: J
authors.lastname: Hausleiter
authors.forename: Melchior
authors.initials: M
authors.lastname: Seyfarth
authors.forename: Michael
authors.initials: M
authors.lastname: Gick
authors.forename: David
authors.initials: D
authors.lastname: Antoniucci
authors.forename: Albert
authors.initials: A
authors.lastname: Schömig
authors.forename: Peter B
authors.initials: PB
authors.lastname: Berger
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
mesh_terms: D000077284:Abciximab; D000328:Adult; D000368:Aged; D000787:Angina Pectoris / Q000188:drug therapy; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012008:Recurrence; D013917:Thrombin / Q000037:antagonists & inhibitors
chemical_list: D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D006629:Hirudins; D007140:Immunoglobulin Fab Fragments; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; D013917:Thrombin; C074619:bivalirudin; D000077284:Abciximab