Gershlick Anthony, De Scheerder Ivan, Chevalier Bernard, Stephens-Lloyd Amanda, Camenzind Edoardo, Vrints Christian, Reifart Nicolaus, Missault Luc, Goy Jean-Jacques, Brinker Jeffrey A, Raizner Albert E, Urban Philip, Heldman Alan W
Department of Cardiology, University Hospitals of Leicester, Glenfield Hospital, Leicester, UK.
Circulation. 2004 Feb 3;109(4):487-93. doi: 10.1161/01.CIR.0000109694.58299.A0. Epub 2004 Jan 26.
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.
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 microg/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-microg/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 (> or =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.
Paclitaxel applied directly to the abluminal surface of a bare metal coronary stent, at a dose density of 2.7 microg/mm2, reduced angiographic indicators of in-stent restenosis without short- or medium-term side effects.
使用支架输送药物可能会减少支架内再狭窄。紫杉醇通过稳定微管来中断平滑肌细胞周期，从而阻止有丝分裂。
基于先前的动物研究，欧洲紫杉醇洗脱支架（ELUTES）试点临床试验（n = 190）研究了V-Flex Plus冠状动脉支架（库克公司）的安全性和有效性，该支架直接在新生病变的支架外膜表面涂覆递增剂量的紫杉醇（0.2、0.7、1.4和2.7μg/mm²支架表面积），并与单纯裸支架进行比较。主要疗效终点是6个月时血管造影的直径狭窄百分比。在血管造影随访中，对照组（n = 34）的直径狭窄百分比为33.9±26.7%，2.7μg/mm²组（n = 31）为14.2±16.6%（P = 0.006）。晚期管腔丢失从0.73±0.73降至0.11±0.50mm（P = 0.002）。二元再狭窄（随访时≥50%）从20.6%降至3.2%（P = 0.056），中等剂量紫杉醇未显示出显著益处。最高（有效）剂量组在1、6和12个月时无重大不良心脏事件的发生率分别为92%、89%和86%（与对照组相比P = 无显著性差异）。尽管仅使用氯吡格雷治疗3个月，但任何治疗组均未观察到晚期支架血栓形成。
以2.7μg/mm²的剂量密度将紫杉醇直接应用于裸金属冠状动脉支架的外膜表面，可降低支架内再狭窄的血管造影指标，且无短期或中期副作用。
