Appendix Table 3. Randomized, Controlled Trials of Effectiveness of Surgery versus Medical Management for Asymptomatic Carotid Artery Stenosisa
Study |
Sample Size &
Intervention Groups |
Demographics/ Comorbidities |
Source of Patients |
Prerandomization
Evaluation & Required Stenosis |
Required
Preoperative
Angiography? |
Angiography Complic. Rate |
WRAMC29 |
Total=29
ASA=14
CEA=15 |
Mean age=63 years
Male: 72%
HTN: 69%
DM: 14%
↑Chol: 10%
Smoke: 72% |
Not reported |
OPG |
Yes | NR |
MACE30 |
Total=71
ASA=35
CEA=36 |
70% >65 years
Male: 56-60%
White: 100% in aspirin group, 97.2% in
CEA group
HTN: 63%
DM: 14-19%
↑Chol: 44-66%
Smoke: 67-74% |
Not reported |
OPG, U/S, or angiogram |
Yes | NR |
VACS31 |
Total=444
MM=233
CEA=211 |
Mean age 65 years
Male: 100%
White: 86-88%
HTN: 63-64%
DM: 27-30%
↑Chol: NR
Smoke: 49-52%
Contralateral TIA/stroke=32% |
Not reported |
A-gram ≥50% |
Yes |
0.4% |
ACAS32 |
Total=1659
MM=834
CEA=825 |
Mean age=67 years
Male: 66%
White: 94-95%
HTN: 64%
DM: 23%
CAD: 69%
↑Chol: %NR
Smoke: 26%
Contralateral CEA=20% |
Vascular ultrasonography
laboratories, physicians who found bruits during evaluation for PVD or
contralateral CEA |
U/S or angiogram ≥60% |
Yes |
1.2% |
ACST33 |
Total=3,120
MM=1,560
CEA=1,560 |
Mean age=68 years
Male: 66%
HTN: 65%
DM: 20%
↑Chol: 73%
Smoke: NR
Non-DM CAD: 27%
Contralateral CEA: 24% |
Medical and surgical clinics |
U/S ≥60% |
No |
- |
Appendix Table 3, Continued
Study |
Mean Follow-up Time |
30-day Complic. Rate of
CEA: Stroke/Death, MI |
Results: any CVA & Perioper. Stroke/death (95% CI) |
Rate of Perioperative
CVA/Death & Subseq. Ipsilat. Stroke (95% CI) |
Quality Rating |
WRAMC29 |
3 years |
Not reported |
ASA=0/15
CEA=3/15 |
Not reported |
Poor |
MACE30 |
23.6 months |
Stroke/death: 4%
MI: 8% |
ASA=0%
CEA=8.3% |
Not reported |
Poor |
VACS31 |
48 months |
Stroke/death: 4.7%
MI: 1.9% |
Five-year incidence of death
or stroke:
MM: 44.2%b
CEA: 41.2%
RR 0.92 (0.69-1.22) |
Not reported |
Fair |
ACAS32 |
2.7 years |
Stroke/death: 2.7%
MI: NR%
Sex:b
Women: 3.6%
Men: 1.7% |
RRR = 20% (-2-37%) |
Five Year:
MM = 11%
CEA = 5.1%
RRR = 53%
ARR = 5.9%
Sex:b
W: RRR 0.17c (-0.96-0.65)
M: RRR 0.66 (0.36-0.82)
Age: b
<68: RRR 0.60 (0.11-0.82)
≥68: RRR 0.43 c (-0.07-0.70) |
Good |
ACST33 |
3.4 years |
Stroke/death: 2.8%
MI: 0.6 %
Sex:e
W: 3.1%
M: 2.2%
Age:e
<65: 2.4%
65-74: 2.3%
≥75: 3.3% |
Five year:
MM = 11.8%
CEA = 6.4%
ARR = 5.4%
RRR = 46%
Sex:d,e
W: ARR = 4.1%
M: ARR= 8.2%
Age:d,e
<65: ARR 7.8%
65-74: ARR 7.5%
≥75: ARR 3.3%c |
Not reported |
Good |
a. Five-year non-perioperative
stroke.
b. Not statistically significantly different.
c. Statistically
significantly different.
d. No significant benefit to CEA in this group.
e. Statistical significance between groups not reported
WRAMC = Walter Reed Army
Medical Center Study; MACE = Mayo Asymptomatic Carotid Endarterectomy Study;
VACS = Veterans Affairs Cooperative Study; ACAS = Asymptomatic Carotid
Atherosclerosis Study; ACST = Asymptomatic Carotid Surgery Trial; NR = Not
reported, MM = Medical Management; ASA = aspirin; CEA = carotid endarterectomy
group; HTN = hypertension; DM = diabetes mellitus; ↑Chol =
hyperlipidemia; CAD = coronary artery disease; TIA = transient ischemic attack;
OPG = ocular pneumoplethysmography; U/S = ultrasound; PVD = peripheral
vascular disease; MI = myocardial infarction; CI = confidence interval; RR =
relative risk; ARR = absolute risk reduction; RRR = relative risk reduction; SE
= standard error; W = women; M = men
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