FAST Trial.

Methods	Study design: RCT Method of randomisation: Concealed randomisation using randomisation envelopes provided by an independent data management organisation. Blinding: Unblinded, intention‐to‐treat. Exclusions post‐randomisation: None. Losses to follow‐up: 6 PTA, 9 stent. Cross‐over to stenting in PTA group: 13.
Participants	Country: Germany. Setting: Hospital. No. of participants: 244 (244 limbs). Age (mean): 66.5 years. Gender: 168 men, 76 women. Inclusion criteria: SFA lesion at least 1 cm from SFA origin and 1cm ‐ 10 cm long; target lesion diameter at least 70% by visual estimate; all distal vessels patent; at least Rutherford 2 chronic limb ischaemia. Exclusion criteria: Target lesion requiring pretreatment such as debulking; target lesion extending into popliteal artery; previous stent in target SFA; multiple lesions exceeding 10 cm; acute or subacute (≤ 4 weeks) thrombotic occlusion; an untreated ipsilateral iliac artery stenosis; ongoing dialysis and treatment with oral anticoagulation other than antiplatelet therapy.
Interventions	PTA (121): over the wire. Stent (123): Nitinol. 100 mg aspirin for at least 10 days or 500 mg bolus preoperative. 3000 ‐ 5000 iu heparin intraoperatively
Outcomes	1, 6 and 12 month follow‐up: ABI, treadmill test, duplex ultrasound. 12‐month biplane radiographs for participants receiving stent (detection of fractures). Primary patency defined as proximal peak velocity ratio ≥ 2.4 on duplex ultrasound.
Notes	Participants with ipsilateral iliac artery stenosis underwent angioplasty and were not excluded. Total occlusion rate difference (25% in PTA participants, 37% stent participant) may bias restenosis results (acknowledged). Gender difference in restenosis rates in PTA arm only (acknowledged). Compliance with aspirin/clopidogrel not assessed. Reassessment blinding not stated. Sponsor: C.R. Bard Inc.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation envelopes.
Allocation concealment (selection bias)	Low risk	4‐block randomisation envelopes from independent data management company.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Impossible in this type of trial.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated but radiological investigations would show stent placement.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No major attrition.
Selective reporting (reporting bias)	Low risk	All outcomes accounted for.
Other bias	High risk	No statement of adherence to medication protocol. Medians quoted and participants with ipsilateral iliac artery stenosis underwent angioplasty but were not excluded.