Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions
Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions
复制标题
DOI：
10.1161/01.cir.0000086926.62288.a6
复制
发表时间：
2003-08-19
期刊：
影响因子：
37.8
通讯作者：
Russell, ME
中科院分区：
文献类型：
--
作者：
Colombo, A;Drzewiecki, J;Russell, ME
背景：早期临床研究表明，在小患者群体中，局部给药紫杉醇可减少新发冠状动脉病变治疗后的再狭窄。方法和结果：我们对38个医疗中心的536名患者进行了一项随机、双盲试验，评估聚合物基紫杉醇洗脱支架（TAXUS）缓释（SR）和中释（MR）制剂用于原生冠状动脉单一原发病变的血供重建术。队列1将TAXUS-SR与对照支架进行比较，队列2将TAXUS-MR与第二个对照组进行比较。主要终点为血管内超声测量的支架内净容积梗阻6个月。次要终点为6个月血管造影再狭窄、6个月和12个月主要心脏不良事件发生率，包括心源性死亡、心肌梗死和重复血运重建术。6个月时，TAXUS支架内的净体积阻塞百分比（SR为7.9%，MR为7.8%）明显低于相应的对照组(23.2%和20.5%
Background-Early clinical studies demonstrated the feasibility of local paclitaxel delivery in reducing restenosis after treatment of de novo coronary lesions in small patient populations.Methods and Results-We conducted a randomized, double-blind trial of 536 patients at 38 medical centers evaluating slow-release (SR) and moderate-release (MR) formulations of a polymer-based paclitaxel-eluting stent (TAXUS) for revascularization of single, primary lesions in native coronary arteries. Cohort I compared TAXUS-SR with control stents, and Cohort II compared TAXUS-MR with a second control group. The primary end point was 6-month percent in-stent net volume obstruction measured by intravascular ultrasound. Secondary end points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse cardiac events, a composite of cardiac death, myocardial infarction, and repeat revascularization. At 6 months, percent net volume obstruction within the stent was significantly lower for TAXUS stents (7.9% SR and 7.8% MR) than for respective controls (23.2% and 20.5%; P