Published online before print January 26, 2004, doi: 10.1161/01.CIR.0000109694.58299.A0
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(Circulation. 2004;109:487-493.)
© 2004 American Heart Association, Inc.
Clinical Investigation and Reports |
Inhibition of Restenosis With a Paclitaxel-Eluting, Polymer-Free Coronary Stent
The European evaLUation of pacliTaxel Eluting Stent (ELUTES) Trial
From the Department of Cardiology, University Hospitals of Leicester (A.G., A.S.-L.), Glenfield Hospital, Leicester, UK; Department of Interventional Cardiology, University Hospitals Leuven (I.D.S.), Leuven, Belgium; Department of Interventional Cardiology, Centre Cardiologique du Nord (B.C.), Saint-Denis, France; University Hospital of Geneva (E.C.), Geneva, Switzerland; University Hospital Antwerp (C.V.), Edegem, Belgium; Department of Kardiologisches Institute of Bad Soden (N.R.), Bad Soden, Germany; A Z St Jan Hospital (L.M.), Brugges, Belgium; Clinique Cecil (J.-J.G.), Lausanne, Switzerland; The Johns Hopkins Medical Institutions (J.A.B., A.W.H.), Baltimore, Md; Methodist De Bakey Heart Center and Baylor College of Medicine (A.E.R.), Houston, Tex; and Cardiovascular Department (P.U.), La Tour Hospital, Geneva, Switzerland.
Correspondence to Anthony Gershlick, Department of Cardiology, University Hospitals of Leicester, Glenfield Hospital, Leicester, UK LE3 9QP.
Received September 26, 2002; de novo received August 11, 2003; revision received October 13, 2003; accepted October 24, 2003.
Background— The use of a stent to deliver a drug may reduce in-stent restenosis. Paclitaxel interrupts the smooth muscle cell cycle by stabilizing microtubules, thereby arresting mitosis.
Methods and Results— On the basis of prior animal studies, the European evaLUation of the pacliTaxel Eluting Stent (ELUTES) pilot clinical trial (n=190) investigated the safety and efficacy of V-Flex Plus coronary stents (Cook Inc) coated with escalating doses of paclitaxel (0.2, 0.7, 1.4, and 2.7 µg/mm2 stent surface area) applied directly to the abluminal surface of the stent in de novo lesions compared with bare stent alone. The primary efficacy end point was angiographic percent diameter stenosis at 6 months. At angiographic follow-up, percent diameter stenosis was 33.9±26.7% in controls (n=34) and 14.2±16.6% in the 2.7-µg/mm2 group (n=31; P=0.006). Late loss decreased from 0.73±0.73 to 0.11±0.50 mm (P=0.002). Binary restenosis (
50% at follow-up) decreased from 20.6% to 3.2% (P=0.056), with no significant benefit from intermediate paclitaxel doses. Freedom from major adverse cardiac events in the highest (effective) dose group was 92%, 89%, and 86% at 1, 6, and 12 months, respectively (P=NS versus control). No late stent thromboses were seen in any treated group despite clopidogrel treatment for 3 months only.
Conclusions— Paclitaxel applied directly to the abluminal surface of a bare metal coronary stent, at a dose density of 2.7 µg/mm2, reduced angiographic indicators of in-stent restenosis without short- or medium-term side effects.
Key Words: stents • restenosis • paclitaxel
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