| Study characteristics |
| Methods |
Randomisation was done by a random number generator using computational method.
Concealment: not reported
Blinding outcome assessment: unclear
No cross‐overs
Exclusions during trial: unclear
Loss to follow‐up: none |
| Participants |
Italy
96 participants
Shunt: 48 participants; no shunt: 48 participants
Age: mean 71.45 years
Gender: 67% male, 33% female
Comparability: age, gender, vascular risk factors, indication for operation, degree of ipsilateral/contralateral stenosis in each group not given
Overall: 66% of all patients had asymptomatic severe carotid stenosis |
| Interventions |
Treatment: Pruitt‐Inahara shunt
Control: no shunt (shunted if stump pressure < 50 mmHg)
All operations done under general anaesthetic with stump pressure measurement
All operations done by eversion carotid endarterectomy technique |
| Outcomes |
Death and stroke, cerebral CT scan, serum concentration of S100 protein, neuron specific enolase, interleukin‐6, neuropsychological test |
| Notes |
Exclusions: contralateral severe carotid stenosis or carotid occlusion, right‐side involvement, age greater than 80 years, dementia, previous disabling stroke, brain tumour, neuroleptic therapy and Mini Mental State Examination score < 24 points
Follow‐up: unclear |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "Randomisation was done by a random number generator using computational method that was managed by a statistician." |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Not reported |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Neuropsychological test was done by psychologists but author did not report whether they knew the randomisation code |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No participants lost to follow‐up |
| Selective reporting (reporting bias) |
Low risk |
Study authors reported all prespecified outcomes. |
| Other bias |
Low risk |
No other potential biases |
