title: A clinical trial of abciximab in elective percutaneous coronary intervention after pretreatment with clopidogrel.
abstract: BACKGROUND
  Whether the glycoprotein IIb/IIIa inhibitor abciximab is beneficial in patients undergoing elective percutaneous coronary intervention after pretreatment with clopidogrel is unknown.
  
  
  METHODS
  We enrolled 2159 patients with coronary artery disease who underwent a percutaneous coronary intervention: 1079 patients were randomly assigned in a double-blind manner to receive abciximab and 1080 patients to receive placebo. All patients were pretreated with a 600-mg dose of clopidogrel at least two hours before the procedure. The primary end point of the trial was the composite of death, myocardial infarction, and urgent target-vessel revascularization within 30 days after randomization.
  
  
  RESULTS
  The incidence of the primary end point was 4 percent (45 patients) in the abciximab group, as compared with 4 percent (43 patients) in the placebo group (relative risk, 1.05; 95 percent confidence interval, 0.69 to 1.59; P=0.82). Most adverse events were myocardial infarctions: the incidence was 4 percent (40 patients) in the abciximab group and 4 percent (41 patients) in the placebo group (P=0.91). Twelve patients (1 percent) in the abciximab group and eight patients (1 percent) in the placebo group had major bleeding complications (P=0.37). Profound thrombocytopenia occurred in 10 patients (1 percent) in the abciximab group but in none in the placebo group (P=0.002).
  
  
  CONCLUSIONS
  Our data suggest that in patients at low-to-intermediate risk who undergo elective percutaneous coronary intervention after pretreatment with a high loading dose of clopidogrel, abciximab is associated with no clinically measurable benefit within the first 30 days.
authors.affiliation: Deutsches Herzzentrum, Munich, Germany. kastrati@dhm.mhn.de
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.forename: Helmut
authors.initials: H
authors.lastname: Schühlen
authors.forename: Josef
authors.initials: J
authors.lastname: Dirschinger
authors.forename: Franz
authors.initials: F
authors.lastname: Dotzer
authors.forename: Jurriën M
authors.initials: JM
authors.lastname: ten Berg
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Hildegard
authors.initials: H
authors.lastname: Bollwein
authors.forename: Christian
authors.initials: C
authors.lastname: Volmer
authors.forename: Meinrad
authors.initials: M
authors.lastname: Gawaz
authors.forename: Peter B
authors.initials: PB
authors.lastname: Berger
authors.forename: Albert
authors.initials: A
authors.lastname: Schömig
mesh_terms: D000077284:Abciximab; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D000077144:Clopidogrel; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000453:epidemiology; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D011300:Preoperative Care; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*
chemical_list: D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D000077144:Clopidogrel; D013988:Ticlopidine; D000077284:Abciximab