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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