药物洗脱支架对远端血管的影响。

Impact of drug-eluting stents on distal vessels.

机构信息

Washington Hospital Center, Washington, DC 20010, USA.

出版信息

Circ Cardiovasc Interv. 2012 Apr;5(2):211-9. doi: 10.1161/CIRCINTERVENTIONS.111.965780. Epub 2012 Apr 10.

DOI:10.1161/CIRCINTERVENTIONS.111.965780

PMID:22496083

Abstract

BACKGROUND

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.

METHODS AND RESULTS

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.

CONCLUSIONS

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.

CLINICAL TRIAL REGISTRATION

URL: HTTP://WWW.CLINICALTRIAL.GOV. Unique identifiers: TAXUS IV: NCT00292474; TAXUS V: NCT00301522; TAXUS VI: NCT00297804.

摘要

背景

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。

方法和结果

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。