CREST
Carotid Revascularization Endarterectomy vs Stent Trial
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Status:
CREST is ongoing, but not recruiting participants. Use of CTA or MRA was approved by NIH and FDA for confirmation of randomization stenosis. The lead-in phase has been closed. Recruitment in the randomized phase was completed July 18, 2008 with 2522 total patient randomizations (1326 symptomatic and 1196 asymptomatic) at 118 U.S. and Canadian sites, CREST is the largest enrolling trial to address the efficacy of CAS versus CEA. Follow-up is ongoing.
Purpose:
To compare the efficacy of carotid artery stenting (CAS) and carotid endarterectomy (CEA) in preventing stroke, myocardial infarction or mortality in both symptomatic and asymptomatic patients with carotid stenosis.
Interventions:
Endarterectomy, carotid
Surgical therapy to remove atherosclerotic plaque in narrowed carotid arteries.
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Stent, carotid
Intravascular procedure to maintain carotid artery patency
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Location(s):
Several US states and Canadian provinces.
Year Started:
2000
Year Presented:
2009
Design:
Prospective, randomized, parallel, two-arm, multi-center clinical trial with blinded endpoint evaluation.
Inclusion Criteria
Patients who have experienced a transient ischemic attack (TIA), amaurosis fugax (AF), or non-disabling stroke within the past 180 days, and who have an ipsilateral carotid stenosis >=50% by angiography or >=70% by ultrasound or >= 70% by CTA or MRA are eligible for this study.
Asymptomatic subjects:
Patients who have carotid stenosis >=60% by angiography or >=70% by ultrasound or >= 80% by CTA or MRA are eligible for this study. (Subjects with symptoms beyond 180 days are considered asymptomatic).
Exclusion Criteria
Patients who have comorbid conditions that interfere with the evaluation of endpoints, that are known to interfere with the completion of CEA or CAS, or that affect the likelihood of survival for the 4-year study period, will be excluded from this study.
Patient Involvement:
Eligible patients will be randomized to undergo either CAS or CEA. All will receive aspirin antiplatelet therapy, treatment for hypertension, and management of other stroke risk factors. Follow-up will last four years, including clinic visits at 1, 6, 12, 18, 24, 30, 36, 42, and 48 months.
Primary Outcome:
Mortality, stroke, or myocardial infarction at 30 days postoperatively; ipsilateral stroke at 30 days post-operatively.
Results:
Of 429 stent operators who applied, 225 (52%) were approved for randomization. Initially, 117 applicants did not meet criteria to advance; the number of cases evaluated ranged from 1 to 56, median 12. The IMC judged that 70 operators of the 429 had sufficient experience, and sufficient experience with the study devices (range: 7–81), to be exempt from the lead-in. A total of 242 applicants met the criteria for the lead-in phase; the number of cases submitted by this group ranged from 3 to 63, median 29. Forty-four did not meet the regulatory and training requirements, moved to another institution or were from an institution that was not CREST-approved. The remaining 198 were approved by the IMC to enroll in the lead-in phase and are board certified (or the Canadian equivalent) in cardiology (40%), vascular surgery (21%), neuroradiology (15%), interventional radiology (15%), neurosurgery (8%) and neurology (2%). Of these 198 operators, 160, completing an average of 9 (range: 1–35) cases, were approved for randomization; the remaining 38 did not do the required number of cases before trial
enrollment ended. Of the 70 lead-in exempt, IMC-approved experienced operators, four were unable to meet the regulatory or training requirements, and one was from an unapproved site. A total of 225 operators at 122 sites were therefore qualified in the Interventional/CAS arm of CREST.
In conclusion, previous RCTs comparing CAS and CEA have been criticized for sub-optimal credentialing and training of
stent operators. The CREST credentialing and training process is the most rigorous reported to date and
may serve as a model for future trials.
Source of Information:
Clinicaltrials.gov.
Correspondence with trial coordinator.
Stroke 33:646, 2002.
Presented at the 30th International Stroke Conference [February 2005].
Presented at the 2006 International Stroke Conference [February 2006].
Presented at the 2007 International Stroke Conference [February 2007].
Presented at the 2008 International Stroke Conference [February 2008].
Presented at the 2009 International Stroke Conference [February 2009].
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Web Links and Publications:
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This information last updated on: 8/26/2009
Reviewed on: 08/26/2009.
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Trials
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