Iyer Vikram, de Donato Gianmarco, Deloose Koen, Peeters Patrick, Castriota Fausto, Cremonesi Alberto, Setacci Carlo, Bosiers Marc
Department of Vascular Surgery, AZ St-Blasius, Dendermonde, Belgium.
J Vasc Surg. 2007 Aug;46(2):251-6. doi: 10.1016/j.jvs.2007.04.053.
The goal of this study was to review our experience with embolic protection devices (EPDs) during carotid artery stenting (CAS). Specifically, we aimed to verify their clinical effectiveness and to compare clinical outcomes between specific devices and types of EPDs.
The CAS databases at four participating centers were reviewed. Adverse events were defined as death, stroke (>24 hours), or transient ischemic attack (TIA) (<24 hours). We compared the risk of procedural and 30-day events between patients treated with and without an EPD. We also compared these risks between different EPDs and between the different types of EPDs.
A total of 3160 CAS procedures using nine EPDs were analyzed. The risk of a procedural adverse event was 0.9% in protected and 2.3% in unprotected procedures (P = .12). Compared with the most frequently used device (FilterWire, Boston Scientific, Natick, Mass), there was no significant difference in the risk of procedural adverse events for any of the other EPDs. There was, however, an increased risk of 30-day adverse events with the Accunet (Abbott Vascular, Redwood, Calif) filter compared with the FilterWire (relative risk [RR] 2.67, confidence interval [CI] 1.41 to 5.04, P = .005). Pairwise comparison of proximal occlusion balloons to filters, distal occlusion balloons to filters, and proximal to distal occlusion balloons revealed no significant difference in the risk of procedural or 30-day adverse events. There was no significant difference in risk of procedural events between eccentric and concentric filters, however, the relative risk of eccentric compared with concentric filters at 30 days was 0.59 (unadjusted, CI 0.38 to 0.92, P = .04). This difference was still apparent after adjustment for risk factors (RR 0.61, CI 0.39 to 0.95, P = .06), but not after adjustment for risk factors and stent-type [(open-cell vs closed-cell) RR 0.76, CI 0.47 to 1.22, P = .51].
The use of EPDs is associated with a low risk of procedural adverse events. We were unable to detect significant differences in risks of procedural adverse events between different devices or types of devices. We speculate that the observed differences seen at 30 days are largely attributable to differences in stent-type used.
本研究的目的是回顾我们在颈动脉支架置入术(CAS)中使用栓塞保护装置(EPD)的经验。具体而言,我们旨在验证其临床有效性,并比较特定装置和不同类型EPD之间的临床结果。
对四个参与中心的CAS数据库进行了回顾。不良事件定义为死亡、卒中(>24小时)或短暂性脑缺血发作(TIA,<24小时)。我们比较了使用和未使用EPD的患者发生手术相关不良事件和30天不良事件的风险。我们还比较了不同EPD之间以及不同类型EPD之间的这些风险。
共分析了使用9种EPD的3160例CAS手术。使用EPD的手术中发生手术相关不良事件的风险为0.9%,未使用EPD的手术中为2.3%(P = 0.12)。与最常用的装置(FilterWire,波士顿科学公司,马萨诸塞州纳蒂克)相比,其他任何EPD发生手术相关不良事件的风险均无显著差异。然而,与FilterWire相比,使用Accunet(雅培血管,加利福尼亚州红木城)滤网发生30天不良事件的风险增加(相对风险[RR]2.67,置信区间[CI]1.41至5.04,P = 0.005)。近端闭塞球囊与滤网、远端闭塞球囊与滤网以及近端与远端闭塞球囊的两两比较显示,手术相关不良事件或30天不良事件的风险无显著差异。偏心滤网和同心滤网在手术相关不良事件风险方面无显著差异,然而,偏心滤网与同心滤网在30天时的相对风险为0.59(未调整,CI 0.38至0.92,P = 0.04)。在对危险因素进行调整后,这种差异仍然明显(RR 0.61,CI 0.39至0.95,P = 0.06),但在对危险因素和支架类型(开孔型与闭孔型)进行调整后差异不再明显(RR 0.76,CI 0.47至1.22,P = 0.51)。
使用EPD与手术相关不良事件的低风险相关。我们未能检测到不同装置或不同类型装置在手术相关不良事件风险上的显著差异。我们推测,观察到的30天时的差异很大程度上归因于所使用支架类型的差异。