Abbot 1997.
Methods | Site: Femoral to AK popliteal Study design: Multicentre RCT Method of randomisation: central randomisation, but exact method unclear Blinding: unblinded, intention to treat Exclusions post randomisation: not discussed Losses to follow up: high rate of losses to follow‐up (37 within first 12 months of follow‐up) |
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Participants | Country: USA Setting: multicentre No. of participants: 231 patients (240 limbs; 122 PTFE, 118 Dacron) Age: mean 67.1 yrs Sex: 145 male, 95 female Inclusion criteria: angiographically demonstrated superficial femoral artery occlusion with reconstitution of a popliteal segment above the knee Exclusion criteria: earlier infrainguinal vascular procedures Unclear whether patients had IC or critical ischaemia |
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Interventions | PTFE versus Dacron (diameter at discretion of operating surgeon) | |
Outcomes | Primary patency, secondary patency, peri‐operative complications | |
Notes | 13 patients randomised but not described. Unclear how many patients had post‐op aspirin | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomised centrally after eligibility was determined by the operating surgeon and informed consent obtained." |
Allocation concealment (selection bias) | Unclear risk | Not specifically stated. Probably not done |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Operative blinding impossible in this type of trial |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessors and patients not obviously blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | 37 patients randomised lost by 12 months |
Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
Other bias | Unclear risk | Anticoagulation protocol not stated |