title: Abciximab and angiographic restenosis after coronary stent placement. Analysis of the angiographic substudy of ISAR-REACT--a double-blind, placebo-controlled, randomized trial evaluating abciximab in patients undergoing elective percutaneous coronary interventions after pretreatment with a high loading dose of clopidogrel.
abstract: BACKGROUND
  ISAR-REACT was a trial designed to evaluate whether the glycoprotein IIb/IIIa inhibitor abciximab is beneficial in patients undergoing elective percutaneous coronary intervention (PCI) with stent placement after pretreatment with a 600 mg loading dose of clopidogrel. Objective for the angiographic substudy was to determine the impact of abciximab on angiographic restenosis after coronary stent placement. Previous analyses have suggested a reduction in the incidence of restenosis after the administration of abciximab.
  
  
  METHODS
  The angiographic substudy comprises 1885 of 2159 patients enrolled in ISAR-REACT: 994 patients were randomly assigned to abciximab and 941 patients to placebo. All patients were scheduled for a routine angiographic follow-up after 6 months (performed in 80% of eligible patients). End points for the angiographic substudy were the rates of angiographic restenosis (> or = 50% diameter stenosis) and target lesion revascularization.
  
  
  RESULTS
  The incidence of angiographic restenosis was 27% in the abciximab group and 29% in the placebo group (relative risk 0.92, 95% CI 0.79-1.06, P = .27). Late angiographic lumen loss was 0.95 +/- 0.68 and 0.99 +/- 0.70 mm, respectively (P = .25). Similar results were obtained in a subgroup analysis focusing on high-risk subsets. The rate of target lesion revascularization procedures was 22% in the abciximab group and 23% in the placebo group (relative risk 0.94, 95% CI 0.79-1.12, P = .52).
  
  
  CONCLUSIONS
  In low- to intermediate-risk patients who undergo elective PCI after pretreatment with a high loading dose of clopidogrel >2 hours before PCI, the additional administration of the glycoprotein IIb/IIIa inhibitor abciximab is not associated with a significant reduction in angiographic restenosis.
authors.affiliation: Deutsches Herzzentrum, Munich, Germany. schuehlen@dhm.mhn.de
authors.forename: Helmut
authors.initials: H
authors.lastname: Schühlen
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.forename: Jörg
authors.initials: J
authors.lastname: Hausleiter
authors.forename: Josef
authors.initials: J
authors.lastname: Dirschinger
authors.forename: Franz
authors.initials: F
authors.lastname: Dotzer
authors.forename: Hildegard
authors.initials: H
authors.lastname: Bollwein
authors.forename: Albert
authors.initials: A
authors.lastname: Schömig
mesh_terms: D000077284:Abciximab; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000077144:Clopidogrel; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control* / Q000628:therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D008297:Male; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D015607:Stents; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*
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