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. 2018 Feb 11;2018(2):CD001487. doi: 10.1002/14651858.CD001487.pub3

Post 2001.

Methods Site: Femoral to AK and BK popliteal
Study design: RCT
Method of randomisation: concealed randomisation using computer generated randomisation envelopes
Blinding: unblinded, intention to treat
Exclusions post randomisation: 3 (1%)
Losses to follow up: 6 (2%)
Participants Country: Germany
Setting: hospital
No. of participants: 203 (194 limbs analysed. AK: 65 PTFE, 76 Dacron, BK: 26 PTFE, 27 Dacron)
Age (median): 66 yrs
Sex: 155 males, 48 females
Inclusion criteria: severe claudication, rest pain, tissue loss
Exclusion criteria: infection, emergency surgery for acute ischaemia, distal anastomosis below anterior tibial origin, concomitant disease not expected to live past 3 years, contraindication to anticoagulants
Interventions PTFE and Dacron (diameter at discretion of operating surgeon)
Post‐op warfarin, heparin or antiplatelet agents
Outcomes Primary patency
3‐year follow up
Notes No consistent anticoagulation protocol. No compliance checks
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The order of Secondary end‐points assignment had been generated by random digits from a statistical software package (SAS)."
Allocation concealment (selection bias) Low risk Quote: "Patients were randomised to either treatment arm intraoperatively by sealed envelopes."
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 Low risk No losses, clear life table data
Selective reporting (reporting bias) Low risk All stated outcomes reported
Other bias Unclear risk No consistent anticoagulation protocol