Evaluation of stent-protected angioplasty for therapy of symptomatic stenoses of the carotid artery. SPACE and other randomized trials

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.