| Methods |
R = odd/even hospital number (patients randomised)
Duplex blind, clinical FU not blind
Crossovers: 3 primary closure to patch, 3 patch to primary closure (all analysed in original group)
Exclusion during trial: none
Patients lost to FU: 10 patch, 7 no patch |
| Participants |
The Netherlands
126 patients
129 operations
73% male
Mean age: 63 years
18% asymptomatic carotid disease
All arteries > 60% stenosis
Comparability: age, sex, vascular risk factors, % asymptomatic disease were similar in each group |
| Interventions |
Rx: saphenous vein patch
Control: primary closure
20% shunted
Postoperative warfarin +/‐ antiplatelet for all |
| Outcomes |
Deaths < 30 days and end of FU
Strokes < 30 days and end of FU
Perioperative occlusion (intravenous DSA)
Wound haemorrhage
Restenosis > 50% or occlusion at end of FU (Duplex and intravenous DSA) |
| Notes |
Ex: simultaneous cardiac surgery
FU: mean 5 years |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
High risk |
C ‐ Inadequate |