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

Int J Stroke. 2010 Feb;5(1):40-6. doi: 10.1111/j.1747-4949.2009.00405.x.


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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Carotid Arteries / surgery*
  • Carotid Stenosis / surgery*
  • Computer Security
  • Data Interpretation, Statistical
  • Endarterectomy, Carotid* / adverse effects
  • Endarterectomy, Carotid* / instrumentation
  • Humans
  • Patient Selection
  • Research Design
  • Sample Size
  • Stents* / adverse effects
  • Treatment Outcome