Catheter-Based Delivery of Fluid Paclitaxel for Prevention of Restenosis in Native Coronary Artery Lesions After Stent Implantation

Abstract

Background-Stents eluting antiproliferative drugs reduce the incidence of restenosis but delay healing of the vascular wall.We assessed the safety and efficacy of catheter-based local delivery of fluid paclitaxel in patients with coronary de novo stenoses after implantation of a bare metal stent.Methods and Results-We conducted a prospective, randomized trial comparing the local delivery of fluid paclitaxel after bare metal stent implantation (group I) with the implantation of a bare metal stent (group II) and the implantation of a paclitaxel-eluting stent (group III) in 204 patients.The primary end point was in-stent late lumen loss.Secondary end points included binary restenosis rate Ͼ50%, minimal lumen diameter, diameter stenosis, and a composite clinical end point (major adverse cardiac events and revascularization of the target lesion) 6 months after intervention.At 6 months, angiography showed an in-stent late lumen loss of 0.61Ϯ0.44mm in group I versus 0.99Ϯ0.72 mm in group II (I versus II, Pϭ0.0006) and 0.44Ϯ0.48mm in group III (noninferiority of I versus III, Pϭ0.023).The 1-sided 95% CI for the true difference of the means of in-stent late lumen loss in groups I and III was Ϫϱ to 0.3174188.The cumulative overall rate of major cardiac events was 13.4% in group I, 26.8% in group II, and 14.9% in group III.Target lesion revascularization rate was 13.4% (group I), 22.1% (group II), and 13.4% (group III).Conclusions-Additional antiproliferative treatment of de novo lesions in native coronary arteries with catheter-based delivery of fluid paclitaxel after bare metal stenting was safe and significantly reduced neointimal proliferation, restenosis, and clinical events compared with bare metal stent implantation alone.