Washington Hospital Center, Washington, DC 20010, USA.
Circ Cardiovasc Interv. 2012 Apr;5(2):211-9. doi: 10.1161/CIRCINTERVENTIONS.111.965780. Epub 2012 Apr 10.
Previous studies have not addressed vessel response >5 mm distal to the stent edge. Therefore, we investigated the impact of paclitaxel-eluting stents (PES) versus bare metal stents (BMS) on distal vessels in the serial intravascular ultrasound substudies of TAXUS IV, V, and VI.
TAXUS IV, V, and VI were double-blind, randomized, multicenter, controlled trials comparing PES with BMS. In their intravascular ultrasound substudies, 103 patients (54 BMS, 49 PES) had intravascular ultrasound data ≥10 mm distal to the stent both postprocedure and at 9 months follow-up. Baseline characteristics were similar between the 2 groups. Multilevel modeling was used to account for the variation between patients and within patients among distal segments. Effect of stent type, time, and their interaction was tested using a mixed effect model controlling for distal segments. Postprocedure lumen and vessel were not significantly different between PES versus BMS; however, lumen (P=0.006) and vessel (P=0.0001) were significantly reduced for BMS at 9-month follow-up but not for PES. Conversely, there was a significant plaque increase from postprocedure to 9-month follow-up for PES (P=0.0008) but not for BMS. These vessel responses were statistically consistent among 0- to 5-mm versus 5- to 10-mm versus 10- to 15-mm segments distal to the stent in both groups.
PES use was associated with plaque increase from baseline to 9-month follow-up >5 mm distal to the stent along with positive remodeling, whereas BMS use was associated with negative remodeling and no plaque increase. These vessel responses were consistent in 5-mm long subsegments: 0 to 5 mm versus 5 to 10 mm versus 10 to 15 mm distal to the stent.
URL: HTTP://WWW.CLINICALTRIAL.GOV. Unique identifiers: TAXUS IV: NCT00292474; TAXUS V: NCT00301522; TAXUS VI: NCT00297804.
先前的研究并未探讨支架边缘远端超过 5 毫米处的血管反应。因此，我们研究了紫杉醇洗脱支架（PES）与裸金属支架（BMS）对 TAXUS IV、V 和 VI 系列血管内超声亚研究中支架远端血管的影响。
TAXUS IV、V 和 VI 是双盲、随机、多中心、对照试验，比较了 PES 与 BMS。在血管内超声亚研究中，103 例患者（54 例 BMS，49 例 PES）在术后和 9 个月随访时均有支架远端 10 毫米以上的血管内超声数据。两组间基线特征相似。采用多水平模型来解释患者间和患者内的差异。使用混合效应模型控制远端节段，检验支架类型、时间及其相互作用的效果。PES 与 BMS 相比，术后管腔和血管无显著差异；然而，BMS 在 9 个月随访时管腔（P=0.006）和血管（P=0.0001）显著减小，但 PES 无显著变化。相反，PES 从术后到 9 个月随访时斑块明显增加（P=0.0008），但 BMS 无明显变化。两组支架远端 0 至 5 毫米、5 至 10 毫米、10 至 15 毫米的节段中，这些血管反应在统计学上是一致的。
PES 的使用与支架远端超过 5 毫米处从基线到 9 个月随访时的斑块增加有关，同时伴有正性重构，而 BMS 的使用与负性重构和斑块无增加有关。这些血管反应在 5 毫米长的亚节段中是一致的：支架远端 0 至 5 毫米、5 至 10 毫米、10 至 15 毫米。
网址：HTTP://WWW.CLINICALTRIAL.GOV。唯一标识符：TAXUS IV：NCT00292474；TAXUS V：NCT00301522；TAXUS VI：NCT00297804。
