Weissman Neil J, Ellis Stephen G, Grube Eberhard, Dawkins Keith D, Greenberg Joel D, Mann Tift, Cannon Louis A, Cambier Patrick A, Fernandez Stephen, Mintz Gary S, Mandinov Lazar, Koglin Joerg, Stone Gregg W
Cardiac Ultrasound and Ultrasound Core Laboratory, Cardiovascular Research Institute/Medstar Research Institute, Washington Hospital Center, 100 Irving Street, NW, Suite EB-5123, Washington, DC 20010, USA.
Eur Heart J. 2007 Jul;28(13):1574-82. doi: 10.1093/eurheartj/ehm174. Epub 2007 May 31.
The TAXUS Express stent has been shown to reduce angiographic restenosis, repeat revascularizations, and neointimal hyperplasia when compared with bare metal stent (BMS) control (TAXUS IV, V, and VI) in individual TAXUS trials. Since intravascular ultrasound (IVUS) methodology and core laboratory were consistent among all three TAXUS trials, an integrated analysis of 956 patients across all IVUS cohorts can be performed providing superior power.
In the TAXUS randomized trials, patients received an Express BMS or paclitaxel-eluting TAXUS Express stent. Volumetric analysis was performed on a selected subgroup at implantation and 9 months. Compared with BMS control, TAXUS increased 9-month lumen volumes (144 +/- 79 vs. 179 +/- 95 mm(3); P < 0.0001) due to reduced neointimal volume (66 +/- 49 vs. 27 +/- 30 mm(3); P < 0.0001). This corresponded to a 61% decrease in net lumen volume obstruction (31 +/- 15 vs. 12 +/- 12 mm(3); P < 0.0001). Lumen loss was similar between groups for the proximal 5 mm outside the stent but was reduced in TAXUS at the distal edge (P = 0.0056). Neointimal hyperplasia was significantly reduced in the double-strut region of overlapping TAXUS vs. BMS control and in high-risk patients with diabetes, long lesions, multiple stents, and multiple overlapping stents. Late-acquired incomplete stent apposition (ISA) was more common with moderate-release TAXUS stents. Importantly, there were no major adverse cardiac events or stent thromboses in any late-acquired ISA patient through 2 years. Univariate and multivariable analyses revealed that longer lesion length and previous myocardial infarction are risk factors for late-acquired ISA.
Integrated analysis of the TAXUS trials shows that the paclitaxel-eluting TAXUS Express stent effectively inhibits in-stent neointimal proliferation, even in high-risk and overlapping stent patients.
与裸金属支架（BMS）对照组相比，TAXUS Express支架在TAXUS各项独立试验（TAXUS IV、V和VI）中已显示出可减少血管造影再狭窄、再次血管重建及新生内膜增生。由于在所有三项TAXUS试验中血管内超声（IVUS）方法和核心实验室保持一致，因此可以对所有IVUS队列中的956例患者进行综合分析，从而提供更强的检验效能。
在TAXUS随机试验中，患者接受了Express BMS或紫杉醇洗脱TAXUS Express支架。在植入时和9个月时对选定亚组进行容积分析。与BMS对照组相比，TAXUS组9个月时管腔容积增加（144±79 vs. 179±95 mm³；P<0.0001），这是由于新生内膜容积减少（从66±49降至27±30 mm³；P<0.0001）。这相当于净管腔容积阻塞减少了61%（从31±15降至12±12 mm³；P<0.0001）。支架外近端5 mm处两组间的管腔丢失相似，但TAXUS组在远端边缘处管腔丢失减少（P = 0.0056）。与BMS对照组相比，在重叠TAXUS组的双支柱区域以及糖尿病、长病变、多支架和多重叠支架的高危患者中，新生内膜增生明显减少。缓释TAXUS支架更常出现迟发性不完全支架贴壁（ISA）。重要的是，在任何迟发性ISA患者中，2年内均未发生重大不良心脏事件或支架血栓形成。单因素和多因素分析显示，病变长度较长和既往心肌梗死是迟发性ISA的危险因素。
TAXUS试验的综合分析表明，紫杉醇洗脱TAXUS Express支架即使在高危和重叠支架患者中也能有效抑制支架内新生内膜增殖。
