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


OBJECTIVE
The objective is to compare the efficacy of CAS versus CEA in patients with symptomatic (> or =50%) or asymptomatic (> or =60%) extracranial carotid stenosis.


METHODS
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.


RESULTS
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.
Sheffet
A J
AJ
Department of Surgery, UMDNJ-New Jersey Medical School, Newark, NJ, USA.
Roubin
G
G
Howard
G
G
Howard
V
V
Moore
W
W
Meschia
J F
JF
Hobson
R W
RW
Brott
T G
TG
D002339:Carotid Arteries / Q000601:surgery*; D016893:Carotid Stenosis / Q000601:surgery*; D016494:Computer Security; D003627:Data Interpretation, Statistical; D016894:Endarterectomy, Carotid / Q000009:adverse effects / Q000295:instrumentation; D006801:Humans; D018579:Patient Selection; D012107:Research Design; D018401:Sample Size; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome