title: Design of the rosuvastatin pretreatment to reduce embolization during Carotid Artery Stenting trial.
abstract: 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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: aCardiac Catheterization Laboratory, Cardiothoracic and Vascular Department, Azienda Ospedaliero-Universitaria, Pisana bInterventional Cardiology, A.O. Fatebenefratelli, Milan cCliniche Humanitas Gavazzeni, Bergamo dCardioangiology Unit, Cardiothoracic and Vascular Department, Azienda Ospedaliero-Universitaria, Pisana, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: De Carlo
authors.forename: Bernardo
authors.initials: B
authors.lastname: Cortese
authors.forename: Matteo
authors.initials: M
authors.lastname: Pennesi
authors.forename: Leonardo
authors.initials: L
authors.lastname: Misuraca
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Conte
authors.forename: Antonino
authors.initials: A
authors.lastname: Pitì
authors.forename: A Sonia
authors.initials: AS
authors.lastname: Petronio
authors.forename: Alberto
authors.initials: A
authors.lastname: Balbarini
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019917:Blood Vessel Prosthesis Implantation / Q000379:methods*; D017536:Carotid Artery, Common / Q000601:surgery*; D016893:Carotid Stenosis / Q000175:diagnosis / Q000601:surgery*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005464:Fluorobenzenes / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage; D020766:Intracranial Embolism / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011300:Preoperative Care / Q000379:methods*; D011446:Prospective Studies; D011474:Prosthesis Design; D011743:Pyrimidines / Q000008:administration & dosage*; D012307:Risk Factors; D000068718:Rosuvastatin Calcium; D015607:Stents; D013449:Sulfonamides / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium