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 |
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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 |
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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 |