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.
OBJECTIVE
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.


METHODS
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.


RESULTS
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).


CONCLUSIONS
Abciximab does not reduce angiographic restenosis or TLR in type 2 diabetic patients undergoing nonurgent coronary stenting.
Chen
Wai-Hong
WH
Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong, China.
Kaul
Upendra
U
Leung
Sum-Kin
SK
Lau
Yuk-Kong
YK
Tan
Huay-Cheem
HC
Leung
Albert Wai-Suen
AW
Lee
Michael Kang-Yin
MK
Li
Shu-Kin
SK
Ng
William
W
Lee
Pui-Yin
PY
Lam
Kwok-Fai
KF
Tse
Hung-Fat
HF
Lau
Chu-Pak
CP
D000077284:Abciximab; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D001241:Aspirin / Q000627:therapeutic use; D001777:Blood Coagulation / Q000187:drug effects; D000077144:Clopidogrel; D017023:Coronary Angiography / Q000379:methods; D003327:Coronary Disease / Q000209:etiology / Q000628:therapy*; D023903:Coronary Restenosis / Q000517:prevention & control*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D011446:Prospective Studies; D015607:Stents; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use
D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin; D000077284:Abciximab