| Methods |
R = opaque, sequentially numbered sealed envelopes (artery randomised)
Duplex blind, clinical FU not blind
Crossovers: none
Exclusions during trial: none
Patients lost to FU: 6 patch, 8 no patch |
| Participants |
USA
136 (109) patients
152 (126) operations
99% male
Mean age: 62 years
23% asymptomatic carotid disease
Comparability: age, sex, vascular risk factors, % asymptomatic disease similar in each group |
| Interventions |
Rx: saphenous vein patch
Control: primary closure
Routine shunt for all
Peri and postoperative aspirin (325 mg) for all |
| Outcomes |
Death < 30 days and end of FU
Stroke < 30 days and end of FU
Perioperative occlusion (ocular pneumoplethysmography)
Wound haemorrhage, infection, cranial nerve palsy
Restenosis > 50% or occlusion at end of FU (Duplex) |
| Notes |
Ex: ICA diameter < 5mm, arteriotomy > 3 cm, looped or kinked ICA
FU: 4 to 5 years |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
