| Methods |
Method of randomisation: opaque, sequentially‐numbered sealed envelopes (artery randomised)
Blind outcome assessment
Cross‐overs: shunt: 35 participants not shunted; no shunt: 10 participants shunted (all participants analysed in original group)
Exclusions during trial: none
Loss to follow‐up: none |
| Participants |
Germany
472 participants, 441 with unilateral operations
Shunt: 250 operations
No shunt: 253 operations
Age: mean 64 years
Sex: 70% male, 30% female
Comparability: age, sex, vascular risk factors, indication for operation, degree of ipsilateral/contralateral stenosis in each group not given
Overall: all had ipsilateral stenosis > 70% (20% asymptomatic); 20% had contralateral stenosis > 80% |
| Interventions |
Treatment: Javid shunt
Control: no shunt (shunted if significant changes on monitoring)
All operations done under general anaesthetic with EEG/SEP monitoring; at end of operation plication, resection, vein interposition was performed to achieve laminar flow on Doppler |
| Outcomes |
Death plus stroke‐related death, any stroke (during the operation and within 30 days), ipsilateral stroke, haemorrhage from operation site, infection at operation site |
| Notes |
Exclusions: bilateral simultaneous endarterectomies, simultaneous reconstruction of supra‐aortic branch and carotid bifurcation
Follow‐up: 30 days |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "the use of the intraluminal Javid shunt was prospectively randomised in a continuous series of 503 CEs" |
| Allocation concealment (selection bias) |
High risk |
Not reported |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Based on unpublished data, a neurologist who was blind to treatment allocation assessed participants post‐operatively |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "In 503 cases evaluated preoperatively and postoperatively by an independent neurologist, the use of a Javid shunt was prospectively randomised." |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Based on unpublished data, there was no loss to follow‐up in this study |
| Selective reporting (reporting bias) |
High risk |
Study authors did not report prespecified outcome |
| Other bias |
High risk |
Not reported |
