[Sapphire: precious stone or ersatz?].
The SAPPHIRE trial compared the results of carotid endarteriectomy to those of carotid artery stenting with an emboli-protection device in patients with carotid artery stenosis and coexisting conditions that potentially increased the risk posed by endarteriectomy. The trial concluded that stenting was not inferior to endarteriectomy. This publication was selected by the AHA among the "Top Ten of Heart Disease and Stroke Research" for 2004. Yet, from the start, it raised a considerable controversy which was already exposed in the Editorial which appeared in the same issue of the NEJM. The present paper analyses and summarizes the various potential bias which raised suspicion regarding the SAPPHIRE data. It also underlines the fact that the results obtained in the SAPPHIRE surgical series are considerably inferior to those generally cited in the literature, or those obtained locally.
Limet
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Département de Chirurgie, CHU Sart Tilman, Liège.
D000800:Angioplasty, Balloon; D016893:Carotid Stenosis / Q000628:therapy*; D016894:Endarterectomy, Carotid; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D015607:Stents