Inhibition of Restenosis With a Paclitaxel-Eluting, Polymer-Free Coronary Stent

Abstract

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 fr...