A randomized, double-blind, placebo-controlled trial of abciximab for prevention of in-stent restenosis in diabetic patients after coronary stenting: results of the ASIAD (Abciximab in Stenting Inhibits restenosis Among Diabetics) Trial

• Published in: The Journal of invasive cardiology Vol. 17; no. 10; pp. 534 - 538
• Main Authors: Chen, Wai-Hong, Kaul, Upendra, Leung, Sum-Kin, Lau, Yuk-Kong, Tan, Huay-Cheem, Leung, Albert Wai-Suen, Lee, Michael Kang-Yin, Li, Shu-Kin, Ng, William, Lee, Pui-Yin, Lam, Kwok-Fai, Tse, Hung-Fat, Lau, Chu-Pak
• Format: Journal Article
• Language: English
• Published: United States 01.10.2005
• Subjects: Antibodies, Monoclonal - therapeutic use; Aspirin - therapeutic use; Blood Coagulation - drug effects; Coronary Angiography - methods; Coronary Disease - etiology; Coronary Disease - therapy; Coronary Restenosis - prevention & control; Diabetes Mellitus, Type 2 - complications; Double-Blind Method; Female; Follow-Up Studies; Humans; Immunoglobulin Fab Fragments - therapeutic use; Male; Middle Aged; Platelet Aggregation Inhibitors - therapeutic use; Platelet Glycoprotein GPIIb-IIIa Complex - antagonists & inhibitors; Prospective Studies; Stents; Ticlopidine - analogs & derivatives; Ticlopidine - therapeutic use
• ISSN: 1557-2501

Coronary stenting is associated with a high incidence of restenosis in patients with diabetes mellitus. Recent data suggest that diabetic patients treated with abciximab have a lower rate of target vessel revascularization (TVR). We sought to investigate whether abciximab can reduce in-stent restenosis after coronary stenting in diabetic patients. In this prospective double-blind trial, we randomly assigned 254 patients with type 2 diabetes mellitus undergoing nonurgent coronary stenting to receive abciximab with an initial heparin bolus of 50 U/kg (n = 128) or placebo with an initial heparin bolus of 70 U/kg (n = 126). All patients received aspirin and clopidogrel before the procedure. The primary endpoint was angiographic restenosis by quantitative coronary angiography at 6 months. The secondary endpoint was death, myocardial infarction (MI), or target lesion revascularization (TLR) at 6 months. The clinical, angiographic, and procedural characteristics were matched between the 2 groups. Angiographic follow-up was completed in 226 patients (90%). Angiographic restenosis occurred in 29.1% of the abciximab group, and 24% of the placebo group (p = 0.30). The rates of the secondary endpoint were similar between the 2 groups (23.4% in the abciximab group versus 22.2% in the placebo group; p = 0.88). TLR was performed on 36 (18.4%) lesions in 29 (23.4%) patients of the abciximab group, and 26 (13.6%) lesions in 23 (18.3%) patients of the placebo groups, respectively (p = 0.21 and 0.35, respectively). Abciximab does not reduce angiographic restenosis or TLR in type 2 diabetic patients undergoing nonurgent coronary stenting.