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

From the Medizinische Klinik III (C.H., K.G.F., T.G., C.Z., A.M., M.G.), Eberhard Karls Universität Tübingen, Germany; Medizinische Klinik II (K.K.H.), Klinikum am Steinenberg, Reutlingen, Germany; Universitätsapotheke (U.H.), Eberhard Karls Universität Tübingen, Germany; Abteilung Innere Medizin II (J.W., T.N.), Universitätsklinikum Ulm, Germany; and Fachbereich Mathematik (J.D.), Universität Stuttgart, Germany.

Correspondence to Christian Herdeg, MD, FESC, Medizinische Klinik III, Eberhard Karls Universität Tübingen, Otfried-Mueller-Straße 10, D-72076 Tübingen, Germany. E-mail christian.herdeg{at}med.uni-tuebingen.de

Received October 10, 2008; accepted April 30, 2009.

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 >50%, 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 0.61±0.44 mm in group I versus 0.99±0.72 mm in group II (I versus II, P=0.0006) and 0.44±0.48 mm in group III (noninferiority of I versus III, P=0.023). The 1-sided 95% CI for the true difference of the means of in-stent late lumen loss in groups I and III was – 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.

Key Words: local drug delivery • angioplasty • paclitaxel • drug-eluting stent • catheter

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