Catheter-based delivery of fluid paclitaxel for prevention of restenosis in native coronary artery lesions after stent implantation

• Published in: Circulation. Cardiovascular interventions Vol. 2; no. 4; pp. 294 - 301
• Main Authors: Herdeg, Christian, Göhring-Frischholz, Katrin, Haase, Karl K, Geisler, Tobias, Zürn, Christine, Hartmann, Ulrike, Wöhrle, Jochen, Nusser, Thorsten, Dippon, Jürgen, May, Andreas E, Gawaz, Meinrad
• Format: Journal Article
• Language: English
• Published: United States 01-08-2009
• Subjects: Aged; Angioplasty, Balloon, Coronary - adverse effects; Angioplasty, Balloon, Coronary - instrumentation; Cardiac Catheterization; Cardiovascular Agents - administration & dosage; Cell Proliferation - drug effects; Coronary Angiography; Coronary Restenosis - diagnostic imaging; Coronary Restenosis - etiology; Coronary Restenosis - prevention & control; Coronary Stenosis - diagnostic imaging; Coronary Stenosis - therapy; Drug-Eluting Stents; Female; Humans; Male; Metals; Middle Aged; Myocardial Infarction - etiology; Myocardial Infarction - prevention & control; Paclitaxel - administration & dosage; Prospective Studies; Prosthesis Design; Single-Blind Method; Stents; Time Factors; Treatment Outcome; Tunica Intima - diagnostic imaging; Tunica Intima - drug effects
• ISSN: 1941-7640; 1941-7632
• DOI: 10.1161/CIRCINTERVENTIONS.108.827865.108.827865

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.
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).
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.