| Methods |
R = odd/even social security number (patients randomised)
Neither duplex nor clinical FU blind
Crossovers: none
Exclusions during trial: none
Patients lost to FU: 12 in total |
| Participants |
USA
87 patients
100 operations
56% male
Mean age: 67 years
40% asymptomatic carotid disease
Comparability: age, sex, vascular risk factors, % asymptomatic disease were similar in each group |
| Interventions |
Rx: polytetrafluoroethylene patch
Control: primary closure
Routine shunting for all
Postoperative aspirin (325 mg) for all |
| Outcomes |
Death < 30 days and end of FU
Stroke < 30 days and end of FU
Perioperative occlusion (Duplex)
Wound haemorrhage, infection, cranial nerve palsy
Restenosis > 50% or occlusion at end of FU (Duplex) |
| Notes |
Ex: previous endarterectomy, simultaneous cardiac surgery, internal carotid artery diameter < 3.5 mm
FU: mean 29 months |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
High risk |
C ‐ Inadequate |
