title: Efficacy of abciximab for patients undergoing balloon angioplasty: data from Japanese evaluation of c7E3 Fab for elective and primary PCI organization in randomized trial (JEPPORT).
abstract: BACKGROUND
  The efficacy and safety of abciximab were investigated in Japanese patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (MI) or unstable angina.
  
  
  RESULTS
  The 973 patients were randomized into 3 groups: the low-dose group (L group) received bolus injection of 0.20 mg/kg followed by 12-h infusion; the high-dose group (H group) received bolus injection of 0.25 mg/kg followed by 12-h infusion; the placebo group (P group) received bolus and infusion of placebo. The incidence of the primary endpoint (30-day post-PCI coronary events: death, MI or urgent revascularization) was 3.6%, 1.6%, and 4.1% in the P, L, and H groups, respectively, with no significant difference between the P and L groups (P=0.104) or between the P and H groups (P=0.772). The incidence of bleeding tended to increase in a dose-dependent manner.
  
  
  CONCLUSIONS
  No significant difference in the incidence of coronary events was found between the placebo and abciximab groups, so the efficacy of abciximab in preventing post-PCI coronary events in Japanese patients was not confirmed.
authors.affiliation: Department of Cardiology, Tenri Hospital, Tenri, Japan. nakagawa@tenriyorozu-hp.or.jp
authors.forename: Yoshihisa
authors.initials: Y
authors.lastname: Nakagawa
authors.forename: Masakiyo
authors.initials: M
authors.lastname: Nobuyoshi
authors.forename: Tetsu
authors.initials: T
authors.lastname: Yamaguchi
authors.forename: Taiichiro
authors.initials: T
authors.lastname: Meguro
authors.forename: Hiroyoshi
authors.initials: H
authors.lastname: Yokoi
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
authors.forename: Saichi
authors.initials: S
authors.lastname: Hosoda
authors.forename: Katsuo
authors.initials: K
authors.lastname: Kanmatsuse
authors.forename: Akira
authors.initials: A
authors.lastname: Matsumori
authors.forename: Shigetake
authors.initials: S
authors.lastname: Sasayama
mesh_terms: D000077284:Abciximab; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000789:Angina, Unstable / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000453:epidemiology; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D012307:Risk Factors
chemical_list: D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D007140:Immunoglobulin Fab Fragments; D000077284:Abciximab