Trial Outcomes & Findings for Carotid Revascularization Endarterectomy Versus Stenting Trial (NCT NCT00004732)
NCT ID: NCT00004732
Last Updated: 2017-05-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2502 participants
Primary outcome timeframe
30 days and 4 years
Results posted on
2017-05-17
Participant Flow
Participant milestones
| Measure |
Carotid-Artery Stenting (CAS)
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.
|
Carotid Endarterectomy (CEA)
CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.
|
|---|---|---|
|
Overall Study
STARTED
|
1262
|
1240
|
|
Overall Study
COMPLETED
|
1193
|
1129
|
|
Overall Study
NOT COMPLETED
|
69
|
111
|
Reasons for withdrawal
| Measure |
Carotid-Artery Stenting (CAS)
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.
|
Carotid Endarterectomy (CEA)
CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
36
|
64
|
|
Overall Study
Lost to Follow-up
|
33
|
47
|
Baseline Characteristics
Carotid Revascularization Endarterectomy Versus Stenting Trial
Baseline characteristics by cohort
| Measure |
Carotid-Artery Stenting
n=1262 Participants
Patients Randomized to CAS
|
Carotid Endarterectomy
n=1240 Participants
Patients Randomized to CEA
|
Total
n=2502 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
69.2 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
69.0 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
455 Participants
n=5 Participants
|
417 Participants
n=7 Participants
|
872 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
807 Participants
n=5 Participants
|
823 Participants
n=7 Participants
|
1630 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1172 Participants
n=5 Participants
|
1160 Participants
n=7 Participants
|
2332 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
81 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Specified
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Symptomatic Status
Asymptomatic
|
594 Participants
n=5 Participants
|
587 Participants
n=7 Participants
|
1181 Participants
n=5 Participants
|
|
Symptomatic Status
Symptomatic
|
668 Participants
n=5 Participants
|
653 Participants
n=7 Participants
|
1321 Participants
n=5 Participants
|
|
Baseline Hypertension
Yes
|
1080 Participants
n=5 Participants
|
1061 Participants
n=7 Participants
|
2141 Participants
n=5 Participants
|
|
Baseline Hypertension
No
|
179 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
351 Participants
n=5 Participants
|
|
Baseline Hypertension
Unknown
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Diabetes Status
Yes
|
384 Participants
n=5 Participants
|
375 Participants
n=7 Participants
|
759 Participants
n=5 Participants
|
|
Diabetes Status
No
|
873 Participants
n=5 Participants
|
857 Participants
n=7 Participants
|
1730 Participants
n=5 Participants
|
|
Diabetes Status
Unknown
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Dyslipidemia
Yes
|
1040 Participants
n=5 Participants
|
1053 Participants
n=7 Participants
|
2093 Participants
n=5 Participants
|
|
Dyslipidemia
No
|
214 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
388 Participants
n=5 Participants
|
|
Dyslipidemia
Unknown
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Present Smoker
Yes
|
329 Participant
n=5 Participants
|
317 Participant
n=7 Participants
|
646 Participant
n=5 Participants
|
|
Present Smoker
No
|
915 Participant
n=5 Participants
|
899 Participant
n=7 Participants
|
1814 Participant
n=5 Participants
|
|
Present Smoker
Unknown
|
18 Participant
n=5 Participants
|
24 Participant
n=7 Participants
|
42 Participant
n=5 Participants
|
|
Lesion Location
Left
|
639 Participants
n=5 Participants
|
648 Participants
n=7 Participants
|
1287 Participants
n=5 Participants
|
|
Lesion Location
Right
|
623 Participants
n=5 Participants
|
592 Participants
n=7 Participants
|
1215 Participants
n=5 Participants
|
|
Systolic Blood Pressure
|
141.6 mmHg
STANDARD_DEVIATION 20.2 • n=5 Participants
|
141.2 mmHg
STANDARD_DEVIATION 20.5 • n=7 Participants
|
141.4 mmHg
STANDARD_DEVIATION 20.3 • n=5 Participants
|
|
Diastolic Blood Pressure
|
74.0 mmHg
STANDARD_DEVIATION 11.6 • n=5 Participants
|
73.9 mmHg
STANDARD_DEVIATION 11.5 • n=7 Participants
|
74.0 mmHg
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Percent Stenosis at Randomization
Moderate (<70%)
|
165 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
351 Participants
n=5 Participants
|
|
Percent Stenosis at Randomization
Severe (>=70%)
|
1097 Participants
n=5 Participants
|
1054 Participants
n=7 Participants
|
2151 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days and 4 yearsThe 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.
Outcome measures
| Measure |
Carotid-Artery Stenting
n=1262 Participants
Patients Randomized to CAS
|
Carotid Endarterectomy
n=1240 Participants
Patients Randomized to CEA
|
|---|---|---|
|
Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years.
|
7.2 Percentage
Standard Error 0.8
|
6.8 Percentage
Standard Error 0.8
|
SECONDARY outcome
Timeframe: 4 years4-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.
Outcome measures
| Measure |
Carotid-Artery Stenting
n=1262 Participants
Patients Randomized to CAS
|
Carotid Endarterectomy
n=1240 Participants
Patients Randomized to CEA
|
|---|---|---|
|
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).
Men
|
6.2 Percentage
Standard Error 0.9
|
6.8 Percentage
Standard Error 1.0
|
|
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).
Women
|
8.9 Percentage
Standard Error 1.4
|
6.7 Percentage
Standard Error 1.3
|
Adverse Events
Carotid-Artery Stenting
Serious events: 322 serious events
Other events: 213 other events
Deaths: 0 deaths
Carotid Endarterectomy
Serious events: 292 serious events
Other events: 212 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carotid-Artery Stenting
n=1262 participants at risk
Patients Randomized to CAS
|
Carotid Endarterectomy
n=1240 participants at risk
Patients Randomized to CEA
|
|---|---|---|
|
Nervous system disorders
Neurologic SAE
|
7.8%
98/1262 • Number of events 124 • Periprocedural period
|
7.5%
93/1240 • Number of events 108 • Periprocedural period
|
|
Vascular disorders
Hemorrhagic/Vascular SAE
|
2.5%
32/1262 • Number of events 40 • Periprocedural period
|
3.2%
40/1240 • Number of events 53 • Periprocedural period
|
|
Blood and lymphatic system disorders
Hemodynamic SAE
|
5.8%
73/1262 • Number of events 80 • Periprocedural period
|
4.5%
56/1240 • Number of events 63 • Periprocedural period
|
|
Infections and infestations
Infectious Disorder SAE
|
2.1%
27/1262 • Number of events 31 • Periprocedural period
|
1.5%
19/1240 • Number of events 19 • Periprocedural period
|
|
Cardiac disorders
Cardiovascular SAE
|
2.9%
36/1262 • Number of events 41 • Periprocedural period
|
4.0%
49/1240 • Number of events 58 • Periprocedural period
|
|
Surgical and medical procedures
Angiographic/Procedural SAE
|
0.71%
9/1262 • Number of events 10 • Periprocedural period
|
0.73%
9/1240 • Number of events 11 • Periprocedural period
|
|
General disorders
Miscellaneous SAE
|
3.4%
43/1262 • Number of events 50 • Periprocedural period
|
3.8%
47/1240 • Number of events 72 • Periprocedural period
|
|
Metabolism and nutrition disorders
Metabolic/Electrolyte SAE
|
0.32%
4/1262 • Number of events 4 • Periprocedural period
|
0.32%
4/1240 • Number of events 4 • Periprocedural period
|
|
General disorders
Other SAE
|
0.08%
1/1262 • Number of events 1 • Periprocedural period
|
0.00%
0/1240 • Periprocedural period
|
Other adverse events
| Measure |
Carotid-Artery Stenting
n=1262 participants at risk
Patients Randomized to CAS
|
Carotid Endarterectomy
n=1240 participants at risk
Patients Randomized to CEA
|
|---|---|---|
|
Nervous system disorders
Neurologic AE (non-endpoint, non-serious)
|
5.2%
65/1262 • Number of events 81 • Periprocedural period
|
5.8%
72/1240 • Number of events 83 • Periprocedural period
|
|
Vascular disorders
Hemorrhagic/vascular AE (not serious)
|
1.7%
21/1262 • Number of events 23 • Periprocedural period
|
1.6%
20/1240 • Number of events 23 • Periprocedural period
|
|
Blood and lymphatic system disorders
Hemodynamic AE (not serious)
|
5.2%
65/1262 • Number of events 73 • Periprocedural period
|
3.6%
45/1240 • Number of events 50 • Periprocedural period
|
|
Infections and infestations
Infectious Disorder AE (not serious)
|
1.0%
13/1262 • Number of events 13 • Periprocedural period
|
0.97%
12/1240 • Number of events 13 • Periprocedural period
|
|
Cardiac disorders
Cardiovascular AE (non-endpoint, non-serious)
|
2.7%
34/1262 • Number of events 41 • Periprocedural period
|
2.9%
36/1240 • Number of events 42 • Periprocedural period
|
|
Surgical and medical procedures
Angiographic/Procedural AE (not serious)
|
1.9%
24/1262 • Number of events 27 • Periprocedural period
|
3.5%
43/1240 • Number of events 49 • Periprocedural period
|
|
General disorders
Other AE (not serious)
|
0.00%
0/1262 • Periprocedural period
|
0.08%
1/1240 • Number of events 1 • Periprocedural period
|
|
Metabolism and nutrition disorders
Metabolic/Electrolyte AE (not serious)
|
0.63%
8/1262 • Number of events 8 • Periprocedural period
|
0.32%
4/1240 • Number of events 4 • Periprocedural period
|
|
General disorders
Miscellaneous Types of AEs (not serious)
|
6.6%
83/1262 • Number of events 132 • Periprocedural period
|
6.9%
86/1240 • Number of events 127 • Periprocedural period
|
|
Nervous system disorders
Neurologic AE (endpoint, non-serious)
|
0.08%
1/1262 • Number of events 1 • Periprocedural period
|
0.00%
0/1240 • Periprocedural period
|
Additional Information
Thomas G. Brott, MD - Principal Investigator
Mayo Clinic
Phone: 904-953-0556
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place