title: Critique of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST): flaws in CREST and its interpretation.
abstract: The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) has been used to support the equivalence of carotid artery stenting (CAS) and carotid endarterectomy (CEA) in the treatment of carotid stenosis in both symptomatic and asymptomatic patients. This inclusion of two different forms of the disease decreased the power and significance of the CREST results and weakened the trial. Other flaws in CREST were the equal weighting of mostly minor myocardial infarctions (MIs) with strokes and death in the peri-procedural, composite 'end' point, but not in the 4-year, long-term 'end' point. Although CAS was associated with 50% fewer peri-procedural MIs compared with CEA, there were >2.5-fold more MIs after CAS than CEA at 4 years. The 4-year MI rate, however, was not a component of the primary 'end' point. Additionally, although the initial CREST report indicated that there was no difference in the outcomes of CAS and CEA according to symptomatic status or sex, subsequent subgroup analyses showed that CAS was associated with significantly higher stroke and death rates than CEA in symptomatic patients, in females and in individuals ≥ 65 years of age. The present article will examine these and other flaws and the details of CREST's results derived from the trial's preplanned subanalyses to show why the claims that CREST demonstrates equivalence of the two therapeutic procedures are unjustified.
authors.affiliation: Department of Vascular Surgery, Red Cross Hospital, Athens, Greece.
authors.forename: K I
authors.initials: KI
authors.lastname: Paraskevas
authors.forename: D P
authors.initials: DP
authors.lastname: Mikhailidis
authors.forename: C D
authors.initials: CD
authors.lastname: Liapis
authors.forename: F J
authors.initials: FJ
authors.lastname: Veith
mesh_terms: D000368:Aged; D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D058070:Asymptomatic Diseases; D016893:Carotid Stenosis / Q000150:complications / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000379:methods; D016894:Endarterectomy, Carotid / Q000009:adverse effects / Q000401:mortality; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D012107:Research Design; D012307:Risk Factors; D015607:Stents; D020521:Stroke / Q000209:etiology; D013810:Therapeutic Equivalency; D013997:Time Factors; D016896:Treatment Outcome