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

Gupta 1991.

Methods Site: Femoral to AK or BK popliteal
Study design: single‐centre RCT
Method of randomisation: selecting a random card from an unsorted deck of cards marked with the choice of graft material
Blinding: unblinded, no documented crossover so as treated/intention to treat analysis not discussed
Exclusions post randomisation: none
Losses to follow up: none
Protocol violations: none
Participants Country: USA
Setting: hospital
No. of participants: 122 (59 AK of whom 29 ringed, 63 BK of whom 29 ringed)
Age (mean): 71 yrs
Sex: split not specified
Inclusion criteria: patients without an available ipsilateral ASV long enough to serve as femoro‐popliteal bypass on the basis of a history of prior removal, duplex ultrasonography, saphenous venography or operative findings requiring an AK or BK femoro‐popliteal bypass. Patients whose life expectancy was judged to be less than 3 years were also included whether or not an ipsilateral ASV was available
 Patients with Rutherford category 1 to 5 ischaemia were eligible, though all but 4 patients had rest pain or tissue loss
Exclusion criteria: patients with extensive necrosis requiring sequential grafts to distal arteries, patients requiring bypass for reasons other than arteriosclerotic occlusive disease
Interventions 6 mm ringed or unringed PTFE
Outcomes Primary patency, secondary patency, limb salvage (secondary patency and limb salvage not presented separately for above and below‐knee grafts so not included)
Notes Clear anticoagulation and antiplatelet protocol
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation by selection of "a random card from an unsorted deck of cards marked with the choice of graft material"
Allocation concealment (selection bias) Unclear risk Timing of randomisation not declared
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 Low risk Clear anticoagulation and antiplatelet protocol