title: 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.
  
  
  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 -infinity 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.
authors.affiliation: Medizinische Klinik III, Eberhard Karls Universität Tübingen, Germany. christian.herdeg@med.uni-tuebingen.de
authors.forename: Christian
authors.initials: C
authors.lastname: Herdeg
authors.forename: Katrin
authors.initials: K
authors.lastname: Göhring-Frischholz
authors.forename: Karl K
authors.initials: KK
authors.lastname: Haase
authors.forename: Tobias
authors.initials: T
authors.lastname: Geisler
authors.forename: Christine
authors.initials: C
authors.lastname: Zürn
authors.forename: Ulrike
authors.initials: U
authors.lastname: Hartmann
authors.forename: Jochen
authors.initials: J
authors.lastname: Wöhrle
authors.forename: Thorsten
authors.initials: T
authors.lastname: Nusser
authors.forename: Jürgen
authors.initials: J
authors.lastname: Dippon
authors.forename: Andreas E
authors.initials: AE
authors.lastname: May
authors.forename: Meinrad
authors.initials: M
authors.lastname: Gawaz
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D006328:Cardiac Catheterization; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D049109:Cell Proliferation / Q000187:drug effects; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D011474:Prosthesis Design; D016037:Single-Blind Method; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D017539:Tunica Intima / Q000000981:diagnostic imaging / Q000187:drug effects
chemical_list: D002317:Cardiovascular Agents; D008670:Metals; D017239:Paclitaxel