Ringleb P, Kunze A, Allenberg J R, Hennerici M, Jansen O, Maurer P C, Zeumer H, Hacke W
Koordinationszentrum der SPACE-Studie, Neurologische Universitätsklinik, Neurologischen Klinik der Ruprect-Karls-Universität, Heidelberg.
Nervenarzt. 2003 Jun;74(6):482-8. doi: 10.1007/s00115-003-1507-4. Epub 2003 May 15.
During recent years, stent-protected angioplasty of the carotid artery (SPAC) has become an alternative to endartectomy (CEA) in many centers. Despite many case reports, case series, and open records, it has not been proven that these therapeutical regimens are comparable regarding complication rates and long-term outcome. Until now, only three randomized trials were published on this theme, two of them only as abstracts. This is not sufficient for answering the question of whether SPAC is a good alternative to CEA. At present, four major, randomized, multicenter trials are being run (EVA3S in France, CREST in the US, ICSS in Great Britain and several other countries, and SPACE in Germany and Austria). About 7,300 patients will be included in these trials. At present, 24 centers are participating in the SPACE trial, recruiting about 350 patients. It has been prospectively agreed that EVA-3S, ICSS, and SPACE will combine their results after completion of initial randomization and follow-up to conduct a combined European meta-analysis of the data. Three to 5 years are needed until these trials' final results will be published. Until then, stent-protected angioplasty should be done only under the consideration that it has not been scientifically evaluated.
近年来，在许多中心，颈动脉支架置入保护下的血管成形术（SPAC）已成为内膜切除术（CEA）的一种替代方法。尽管有许多病例报告、病例系列和公开记录，但尚未证实这些治疗方案在并发症发生率和长期疗效方面具有可比性。到目前为止，关于这个主题仅发表了三项随机试验，其中两项仅以摘要形式发表。这不足以回答SPAC是否是CEA的良好替代方法这一问题。目前，正在进行四项大型、随机、多中心试验（法国的EVA3S、美国的CREST、英国及其他几个国家的ICSS以及德国和奥地利的SPACE）。这些试验将纳入约7300名患者。目前，有24个中心参与SPACE试验，招募约350名患者。已前瞻性地达成共识，EVA - 3S、ICSS和SPACE将在完成初始随机分组和随访后合并其结果，以对数据进行欧洲联合荟萃分析。需要三到五年时间这些试验的最终结果才会公布。在此之前，进行颈动脉支架置入保护下的血管成形术时应仅在考虑到其尚未经过科学评估的情况下进行。
