Jansen Olav, Fiehler Jens, Hartmann Marius, Brückmann Hartmut
University of Kiel, Arnold-Heller Str.3, Kiel, D-24105 Germany.
Stroke. 2009 Mar;40(3):841-6. doi: 10.1161/STROKEAHA.108.534289. Epub 2009 Jan 15.
The use of protection devices (PDs) and stents with different cell designs in carotid artery stenting (CAS) is a subject of controversy, and no data on their benefit are available from independently controlled multi-center studies.
We analyzed data from the prospective randomized SPACE trial, which included 563 patients randomized to CAS and treated per protocol. A total of 145 patients were treated with a PD and 418 without. Of the patients, 436 were treated with an open cell stent and 127 with a closed cell stent. Use of PDs and choice of device was chosen at the individual discretion of the interventionalist.
The outcome event (OE) of the analysis (ipsilateral stroke or ipsilateral stroke death within 30 days) was reached in 26/418 patients (6.2%, 95% CI: 4.1 to 9.0%) in the nonprotection [corrected] group and in 12/145 (8.3%, 95% CI: 4.3 to 14.0%) patients in the protection [corrected] group (P=0.40). The OE rate was significantly lower in patients treated with a closed cell stent (5.6% [95% CI: 3.7 to 8.2%]) than in those treated with an open cell stent.(11.0%, 95% CI: 6.2 to 17.8%; P=0.029). Predilatation showed a tendency to but no significant reduction of OE rate. Overall, 49% of all OEs occurred directly periinterventionally, 10% during the navigation procedure and 41% postinterventionally, including 10% of hyperperfusion syndromes. Time point of the event was not influenced by the use of a PD.
This secondary analysis of data from the SPACE trial does not support the need for a PD in CAS. Stent design seems to have an impact on the OE rate. Our analysis demonstrates that the choice of the interventional material may have an impact on the periprocedural complication rate in CAS and that the development of more specific stent systems for the treatment of carotid stenosis may reduce the complication rate significantly.
在颈动脉支架置入术（CAS）中使用具有不同网格设计的保护装置（PDs）和支架存在争议，且尚无来自独立对照多中心研究的关于其益处的数据。
我们分析了前瞻性随机SPACE试验的数据，该试验纳入了563例随机接受CAS并按方案治疗的患者。共有145例患者接受了PD治疗，418例未接受。在这些患者中，436例接受了开孔支架治疗，127例接受了闭孔支架治疗。PD的使用和器械的选择由介入医生自行决定。
在未使用保护装置组的418例患者中有26例（6.2%，95%CI：4.1%至9.0%）发生了分析的结局事件（OE）（同侧卒中或30天内同侧卒中死亡），在使用保护装置组的145例患者中有12例（8.3%，95%CI：4.3%至14.0%）发生（P = 0.40）。接受闭孔支架治疗的患者的OE率（5.6%[95%CI：3.7%至8.2%]）显著低于接受开孔支架治疗的患者（11.0%，95%CI：6.2%至17.8%；P = 0.029）。预扩张显示出OE率有降低趋势但不显著。总体而言，所有OE中有49%直接发生在介入治疗期间，10%发生在导航过程中，41%发生在介入治疗后，包括10%的高灌注综合征。事件发生的时间点不受PD使用的影响。
对SPACE试验数据的这项二次分析不支持在CAS中使用PD。支架设计似乎对OE率有影响。我们的分析表明，介入材料的选择可能对CAS的围手术期并发症率有影响，并且开发更具针对性的用于治疗颈动脉狭窄的支架系统可能会显著降低并发症率。
