Impact of abciximab on coronary restenosis in diabetic patients undergoing elective paclitaxel-eluting stent implantation. A prospective, randomized, placebo-controlled study.
OBJECTIVE
Recent studies suggested that abciximab reduces the risk of restenosis in diabetic patients receiving coronary bare metal stent. We sought to evaluate whether abciximab may reduce in-segment late luminal loss (LLL), in patients with diabetes mellitus undergoing elective drug-eluting stents (PES) implantation.


RESULTS
We conducted a prospective, randomized, double-blind study on diabetic patients after a paclitaxel-eluting stent (PES) implantation on de novo coronary artery lesions. 132 consecutive patients with diabetes (mean age 63.1+/-7.4 years, 82 males) were randomized to abciximab (n=66) or placebo (n=66). Among the 124 (93.9%) patients who underwent a 6-months angiographic follow-up, the mean difference in in-segment LLL between patients who received abciximab and placebo was 0.02 mm (P=0.8). In addition, the rates of angiographic in-segment restenosis were comparable between the two groups (14.3 versus 9.8%, P=0.5). Cumulative rates of clinical events did not differ (death: 1.5 versus 1.5, P=0.9 and MI: 1.5 versus 3%, P=0.8) between abciximab and placebo group, respectively. Similarly, the incidence of target lesion revascularization was 9.1% and 6.1% (P=0.7) at six months, in the two groups.


CONCLUSIONS
Abciximab does not seem to have any impact on the extent of in-segment LLL in diabetic patients undergoing an elective PES implantation.
De Luca
Leonardo
L
Department of Cardiovascular Sciences, Laboratory of Interventional Cardiology, European Hospital, Rome, Italy. leo.deluca@libero.it
Sardella
Gennaro
G
De Persio
Giovanni
G
Petrolini
Alessandro
A
Fedele
Francesco
F
D000077284:Abciximab; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000150:complications / Q000000981:diagnostic imaging / Q000601:surgery*; D048909:Diabetes Complications / Q000097:blood / Q000150:complications*; D004311:Double-Blind Method; D017558:Elective Surgical Procedures / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization / Q000295:instrumentation*; D017239:Paclitaxel / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D000972:Antineoplastic Agents, Phytogenic; D020099:Coated Materials, Biocompatible; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D017239:Paclitaxel; D000077284:Abciximab