Design of the rosuvastatin pretreatment to reduce embolization during carotid artery stenting trial

BACKGROUND: Carotid artery stenting (CAS) is a worldwide diffuse intervention, but may be associated with distal plaque component embolization, and sometimes major and minor stroke. Statin use has been demonstrated to reduce atherosclerotic plaque burden, but its effect in reducing distal embolization during carotid stenting has not yet been well validated. AIMS: With the Rosuvastatin Pretreatment to Reduce Embolization during Carotid Artery Stenting trial, we aim to discover if a pretreatement with high doses of rosuvastatin in dyslipidemic patients is able to reduce periprocedural cerebral ischemic complications following carotid stenting. METHODS: This is a phase III prospective, randomized controlled trial. All consecutive patients with asymptomatic carotid stenosis at least 80% will be randomized to a 6-week rosuvastatin treatment followed by carotid stenting, and to direct carotid stenting. Carotid stenting will be performed following common practice with distal or proximal embolic protection. The primary efficacy end point of the trial will be the prevalence of 'relevant' embolization during CAS, as a surrogate end point for cerebral ischemic complications. Other laboratory and clinical data will be registered and patients will be followed up to 1 year. In order to obtain the expected superiority of statin pretreatment on primary end point, a population of 130 patients will be enrolled into the study. CONCLUSION: In conclusion, with the Rosuvastatin Pretreatment to Reduce Embolization during Carotid Artery Stenting trial, we want to evaluate whether a high dose of rosuvastatin for 6 weeks before CAS in asymptomatic patients with severe carotid stenosis is able to reduce the rate of plaque embolization during the procedure, thus suggesting a possible reduction in cerebral ischemic complications. © 2014 Italian Federation of Cardiology.