Lumsden 2015.

Methods	Site: Femoral to AK or BK popliteal Study design: multicentre RCT Method of randomisation: not stated Blinding: unblinded, as treated analysis Exclusions post randomisation: 3 (1.4%) Losses to follow up: 4 (1.9%) Protocol violations: 1 (treatment with a non test graft)
Participants	Country: 18 centres in the USA and 7 in Europe Setting: hospital No. of participants: 209 (105 FUSION BIOLINE, 101 standard ePTFE, 2 no graft implanted, 1 non test graft implanted so latter 3 excluded) Age (median): 62 yrs in standard ePTFE group, 67 in FUSION BIOLINE group Sex: 145 males, 58 females; 2 excluded Inclusion criteria: patients requiring an AK or BK femoro‐popliteal bypass with the proximal anastomosis at the level of the distal external iliac, common femoral, profunda femoral, or proximal superficial femoral artery. The study protocol specified that a prosthetic femoro‐popliteal bypass must be medically necessary, but did not, per se, exclude those without an adequate autogenous conduit. Patients with Rutherford category 1 to 5 ischaemia were eligible, with symptoms of claudication, rest pain, or with superficial ulceration in the target lower extremity Exclusion criteria: acute arterial occlusion requiring urgent intervention; prior open surgical bypass in the target extremity; angioplasty or stenting at the site of a planned anastomosis within the previous 30 days; serum creatinine > 2.5 mg/dL; recent (< 6 weeks) MI or stroke; coagulation or bleeding disorders; receiving warfarin therapy where oral anticoagulation could not be withheld
Interventions	FUSION BIOLINE heparin coated vascular graft or standard ePTFE graft (diameter at discretion of operating surgeon)
Outcomes	Primary endpoints: efficacy: primary graft patency at 6 months as assessed by duplex ultrasound imaging and ABI. Safety: the composite of MALE and POD. MALE included major amputation, major graft reintervention with placement of a new graft or an interposition graft, open or percutaneous graft thrombectomy, pharmacologic thrombolysis, or graft excision. POD was defined as those that occurred within 30 days of the index procedure or any remedial procedure performed at the same anatomic site. Secondary endpoints: efficacy: primary assisted patency, secondary patency, and bleeding at the suture hole as judged subjectively by the operating surgeon and objectively by recording the time between restoration of flow into the graft and the absence of detectable bleeding from the suture holes
Notes	No consistent anticoagulation protocol
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No description of randomisation sequence generation technique
Allocation concealment (selection bias)	Unclear risk	Timing and method of randomisation allocation not stated
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	Only 4 patients had missing data at 6‐month follow‐up
Selective reporting (reporting bias)	Low risk	All stated outcomes reported
Other bias	Unclear risk	No consistent anticoagulation protocol