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Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)

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ClinicalTrials.gov Identifier: NCT00004732
Recruitment Status : Completed
First Posted : February 28, 2000
Results First Posted : December 10, 2013
Last Update Posted : May 17, 2017
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Alabama at Birmingham
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Atherosclerosis
Stroke
Carotid Stenosis
Cerebral Infarction
Myocardial Infarction
Interventions Procedure: Carotid Endarterectomy (CEA)
Device: Carotid Artery Stenting (CAS)
Enrollment 2502

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carotid-Artery Stenting (CAS) Carotid Endarterectomy (CEA)
Hide Arm/Group Description CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. The stent is then placed to cover the plaque and hold the artery open. CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.
Period Title: Overall Study
Started 1262 1240
Completed 1193 1129
Not Completed 69 111
Reason Not Completed
Withdrawal by Subject             36             64
Lost to Follow-up             33             47
Arm/Group Title Carotid-Artery Stenting Carotid Endarterectomy Total
Hide Arm/Group Description Patients Randomized to CAS Patients Randomized to CEA Total of all reporting groups
Overall Number of Baseline Participants 1262 1240 2502
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1262 participants 1240 participants 2502 participants
68.9  (9.0) 69.2  (8.7) 69.0  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1262 participants 1240 participants 2502 participants
Female
455
  36.1%
417
  33.6%
872
  34.9%
Male
807
  63.9%
823
  66.4%
1630
  65.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1262 participants 1240 participants 2502 participants
White 1172 1160 2332
Non-White 81 71 152
Not Specified 9 9 18
Symptomatic Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1262 participants 1240 participants 2502 participants
Asymptomatic 594 587 1181
Symptomatic 668 653 1321
Baseline Hypertension  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1262 participants 1240 participants 2502 participants
Yes 1080 1061 2141
No 179 172 351
Unknown 3 7 10
Diabetes Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1262 participants 1240 participants 2502 participants
Yes 384 375 759
No 873 857 1730
Unknown 5 8 13
Dyslipidemia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1262 participants 1240 participants 2502 participants
Yes 1040 1053 2093
No 214 174 388
Unknown 8 13 21
Present Smoker  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 1262 participants 1240 participants 2502 participants
Yes 329 317 646
No 915 899 1814
Unknown 18 24 42
Lesion Location  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1262 participants 1240 participants 2502 participants
Left 639 648 1287
Right 623 592 1215
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 1262 participants 1240 participants 2502 participants
141.6  (20.2) 141.2  (20.5) 141.4  (20.3)
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 1262 participants 1240 participants 2502 participants
74.0  (11.6) 73.9  (11.5) 74.0  (11.5)
Percent Stenosis at Randomization  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1262 participants 1240 participants 2502 participants
Moderate (<70%) 165 186 351
Severe (>=70%) 1097 1054 2151
1.Primary Outcome
Title Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years.
Hide Description The primary aim of CREST is to assess if the efficacy of CAS differs from that of CEA in preventing stroke, myocardial infarction and death during a 30-day peri-procedural period, or ipsilateral stroke over the follow-up period in patients with symptomatic (>=50%) or asymptomatic (>=60%) extracranial carotid stenosis. Four-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.
Time Frame 30 days and 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carotid-Artery Stenting Carotid Endarterectomy
Hide Arm/Group Description:
Patients Randomized to CAS
Patients Randomized to CEA
Overall Number of Participants Analyzed 1262 1240
Mean (Standard Error)
Unit of Measure: Percentage
7.2  (0.8) 6.8  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Carotid-Artery Stenting, Carotid Endarterectomy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.81 to 1.51
Estimation Comments HR (95% CI) adjusted for age, sex and symptomatic status
2.Secondary Outcome
Title Differential Efficacy of CAS and CEA in Male and Female Participants in the Primary Endpoint (Any Periprocedural Stroke, Myocardial Infarction, or Death or Postprocedural Ipsilateral Stroke).
Hide Description 4-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.
Time Frame 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carotid-Artery Stenting Carotid Endarterectomy
Hide Arm/Group Description:
Patients randomized to CAS
Patients randomized to CEA
Overall Number of Participants Analyzed 1262 1240
Mean (Standard Error)
Unit of Measure: Percentage
Men 6.2  (0.9) 6.8  (1.0)
Women 8.9  (1.4) 6.7  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Carotid-Artery Stenting, Carotid Endarterectomy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.35
Confidence Interval (2-Sided) 95%
0.82 to 2.23
Estimation Comments HR (95% CI) for WOMEN CAS vs CEA (adjusted for age and symptomatic status)
Time Frame Periprocedural period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carotid-Artery Stenting Carotid Endarterectomy
Hide Arm/Group Description Patients Randomized to CAS Patients Randomized to CEA
All-Cause Mortality
Carotid-Artery Stenting Carotid Endarterectomy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Carotid-Artery Stenting Carotid Endarterectomy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   322/1262 (25.52%)      292/1240 (23.55%)    
Blood and lymphatic system disorders     
Hemodynamic SAE   73/1262 (5.78%)  80 56/1240 (4.52%)  63
Cardiac disorders     
Cardiovascular SAE   36/1262 (2.85%)  41 49/1240 (3.95%)  58
General disorders     
Miscellaneous SAE   43/1262 (3.41%)  50 47/1240 (3.79%)  72
Other SAE   1/1262 (0.08%)  1 0/1240 (0.00%)  0
Infections and infestations     
Infectious Disorder SAE   27/1262 (2.14%)  31 19/1240 (1.53%)  19
Metabolism and nutrition disorders     
Metabolic/Electrolyte SAE   4/1262 (0.32%)  4 4/1240 (0.32%)  4
Nervous system disorders     
Neurologic SAE   98/1262 (7.77%)  124 93/1240 (7.50%)  108
Surgical and medical procedures     
Angiographic/Procedural SAE   9/1262 (0.71%)  10 9/1240 (0.73%)  11
Vascular disorders     
Hemorrhagic/Vascular SAE   32/1262 (2.54%)  40 40/1240 (3.23%)  53
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Carotid-Artery Stenting Carotid Endarterectomy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   213/1262 (16.88%)      212/1240 (17.10%)    
Blood and lymphatic system disorders     
Hemodynamic AE (not serious)   65/1262 (5.15%)  73 45/1240 (3.63%)  50
Cardiac disorders     
Cardiovascular AE (non-endpoint, non-serious)   34/1262 (2.69%)  41 36/1240 (2.90%)  42
General disorders     
Other AE (not serious)   0/1262 (0.00%)  0 1/1240 (0.08%)  1
Miscellaneous Types of AEs (not serious)   83/1262 (6.58%)  132 86/1240 (6.94%)  127
Infections and infestations     
Infectious Disorder AE (not serious)   13/1262 (1.03%)  13 12/1240 (0.97%)  13
Metabolism and nutrition disorders     
Metabolic/Electrolyte AE (not serious)   8/1262 (0.63%)  8 4/1240 (0.32%)  4
Nervous system disorders     
Neurologic AE (non-endpoint, non-serious)   65/1262 (5.15%)  81 72/1240 (5.81%)  83
Neurologic AE (endpoint, non-serious)   1/1262 (0.08%)  1 0/1240 (0.00%)  0
Surgical and medical procedures     
Angiographic/Procedural AE (not serious)   24/1262 (1.90%)  27 43/1240 (3.47%)  49
Vascular disorders     
Hemorrhagic/vascular AE (not serious)   21/1262 (1.66%)  23 20/1240 (1.61%)  23
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Thomas G. Brott, MD - Principal Investigator
Organization: Mayo Clinic
Phone: 904-953-0556
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00004732     History of Changes
Other Study ID Numbers: 0119970017
R01NS038384 ( U.S. NIH Grant/Contract )
First Submitted: February 25, 2000
First Posted: February 28, 2000
Results First Submitted: September 26, 2013
Results First Posted: December 10, 2013
Last Update Posted: May 17, 2017