Design of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST).

Academic Article

Abstract

  • RATIONALE: Carotid endarterectomy (CEA) and medical therapy were shown superior to medical therapy alone for symptomatic (> or =50%) and asymptomatic (> or =60%) stenosis. Carotid angioplasty stenting (CAS) offers a less invasive alternative. Establishing safety, efficacy, and durability of CAS requires rigorous comparison with CEA in symptomatic and asymptomatic patients. AIMS: The objective is to compare the efficacy of CAS versus CEA in patients with symptomatic (> or =50%) or asymptomatic (> or =60%) extracranial carotid stenosis. DESIGN: The Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) is a prospective, randomized, parallel, two-arm, multi-center trial with blinded endpoint adjudication. Primary endpoints are analyzed using standard time-to-event statistical modeling with adjustment for major baseline covariates. Primary analysis is on an intent-to-treat basis. STUDY OUTCOMES: The primary outcome is the occurrence of any stroke, myocardial infarction, or death during a 30-day peri-procedural period, and ipsilateral stroke during follow-up of up to four years. Secondary outcomes include restenosis and health-related quality of life.
  • Published In

    Keywords

  • Carotid Arteries, Carotid Stenosis, Computer Security, Data Interpretation, Statistical, Endarterectomy, Carotid, Humans, Patient Selection, Research Design, Sample Size, Stents, Treatment Outcome
  • Digital Object Identifier (doi)

    Author List

  • Sheffet AJ; Roubin G; Howard G; Howard V; Moore W; Meschia JF; Hobson RW; Brott TG
  • Start Page

  • 40
  • End Page

  • 46
  • Volume

  • 5
  • Issue

  • 1