Two-year clinical outcome after abciximab-coated stent implantation in patients with coronary artery disease.

BACKGROUND Despite abciximab-coated stents having an inhibitory effect on coronary artery restenosis, the medium-term clinical outcome is unknown. METHODS AND RESULTS This prospective, randomized study compared the effects of the abciximab-coated stent, which was implanted in 95 patients, with those of control bare metal stents (BMS) implanted in 93 patients for de novo coronary lesions. Stent implantation was performed without any complications associated with the procedure. The 6-month intravascular ultrasound analysis showed that the area of neointimal hyperplasia was significantly smaller in the abciximab-coated stent group compared with the control stent group (+2.0+/-1.6 mm(2) vs +3.4+/-1.7 mm(2), P=0.001). However, at 2-year clinical follow up, there were no statistically significant differences in the incidences of total major adverse cardiac events (16% vs 24%, P=0.19) and cardiac death (0% vs 1.1%, P=0.3), target vessel revascularization (16% vs 21%, P=0.4) or non-fatal myocardial infarction (0% vs 2.3%, P=0.16) in the abciximab-coated stent group compared with the control stent group. CONCLUSIONS Although abciximab-coated stents are safe and inhibit neointimal hyperplasia, they have no superiority over BMS in 2-year clinical outcome.