| Methods |
R = envelope
Duplex blind, clinical FU not blind
Crossovers: unknown
Indication for shunt in any sign of ischaemia from transcranial Doppler, cerebral function monitor, near infrared spectrscopy, Doppler flowmetry
Exclusion during trial: none
Patients lost to FU: 7 patch, 8 no patch |
| Participants |
England
321 patients
338 operations
68% male
Mean age: 69 years
10% asymptomatic carotid disease
% stenosis unknown
Comparability: age, sex, vascular risk factors, % asymptomatic disease were similar in each group |
| Interventions |
Rx: collagen‐coated polyester vascular patch
Control: primary closure
% shunted: unknown
After surgery, all patients were given rectal aspirin (600 mg) |
| Outcomes |
Deaths < 30 days and end of FU
Strokes < 30 days and end of FU
Perioperative occlusion
Bleeding or evacuation clot
Cardiac event
Restenosis > 50% or occlusion at end of FU (ultrasound) |
| Notes |
Ex: 10 patients due to: poor cerebral blood flow (3 patients), ST depression (1 patient), high tortuosity (6 patients)
FU: 12 months |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
C ‐ Inadequate |
