Methods |
R = computer‐generated sealed envelopes (artery randomised)
Both duplex and clinical FU blinded
Crossovers: 4 patients in vein group underwent primary closure and were excluded from the trial; 3 jugular vein patients had saphenous vein and were included in trial |
Participants |
USA
357 patients, 399 operations in three arms: 130 vein, 134 PTFE and 135 primary closure
50% male
Mean age: 68 years
33% asymptomatic
Comparability: age, sex, vascular risk factors, % asymptomatic disease similar in each group |
Interventions |
Rx: polytetrafluoroethylene patch or alternating saphenous vein patch (from ankle) and jugular vein
Control: primary closure
Routine shunting for all and GA
325 mg daily aspirin was started within 24 hours of surgery for all patients |
Outcomes |
Death, ipsilateral stroke, ipsilateral TIA and ipsilateral RIND at 30 days and 48 months
Duplex evidence of restenosis > 50% during follow up |
Notes |
Ex: patients with ICA < 4 mm or combined CABG or redo surgery
FU: mean 30 months |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Low risk |
A ‐ Adequate |