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)

• Published in: Circulation Journal Vol. 73; no. 1; pp. 145 - 151
• Main Authors: Nakagawa, Yoshihisa, Nobuyoshi, Masakiyo, Yamaguchi, Tetsu, Meguro, Taiichiro, Yokoi, Hiroyoshi, Kimura, Takeshi, Hosoda, Saichi, Kanmatsuse, Katsuo, Matsumori, Akira, Sasayama, Shigetake
• Format: Journal Article
• Language: English
• Published: Japan The Japanese Circulation Society 2009
• Subjects: Abciximab; Adult; Aged; Aged, 80 and over; Angina, Unstable - therapy; Angioplasty; Angioplasty, Balloon, Coronary - methods; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - therapeutic use; Anticoagulants - adverse effects; Anticoagulants - therapeutic use; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; GPIIb/IIIa; Hemorrhage - epidemiology; Humans; Immunoglobulin Fab Fragments - adverse effects; Immunoglobulin Fab Fragments - therapeutic use; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial infarction; Myocardial Infarction - therapy; Risk Factors; Unstable angina
• ISSN: 1346-9843; 1347-4820
• DOI: 10.1253/circj.CJ-08-0560

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. Methods and 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. Conclusion 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. (Circ J 2009; 73: 145 - 151)