Ott 2017.

Study characteristics
Methods	Randomisation method: computer‐generated sequence Allocation: sealed, opaque envelopes Intervention model: parallel assignment Blinding: single (outcomes assessor)
Participants	Country: Germany No. of participants: 155 Plain BA followed by PEB angioplasty and stenting: 48 BA and stenting: 52 Atherectomy with distal protection and bailout stenting: 55 Age (mean (years) ± SD): PEB + stent: 69.7 ± 9.4 BA + stent: 69.2 ± 8 Atherectomy: 68.8 ± 10 Inclusion criteria: de novo stenosis > 70% or occlusion of the SFA Exclusion criteria: acute ischaemia or acute thrombosis of the SFA; untreated ipsilateral iliac artery stenosis > 70%; previous stenting of the SFA; popliteal stenosis > 70%; severe renal insufficiency (estimated glomerular filtration rate < 30 mL/minute/1.73m2); life expectancy of < 1 year; and contraindication to required medications.
Interventions	Plain BA followed by PEB angioplasty and stenting versus BA and stenting versus atherectomy with distal protection and bailout stenting.
Outcomes	Primary outcome: percentage diameter stenosis after 6 months, measured by angiography. Secondary outcomes: TLR; thrombosis; ipsilateral amputation; binary restenosis; and all‐cause mortality at 6 and 24 months.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated sequence.
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes opened after decision to proceed with the intervention. Randomisation performed only after guidewire passed and inclusion and exclusion criteria assessed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding of participants or personnel.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Independent core laboratory was blinded to the treatment assignment.
Incomplete outcome data (attrition bias) All outcomes	High risk	39/155 (25%) participants did not provide primary outcome data.
Selective reporting (reporting bias)	Low risk	All primary and secondary outcomes addressed.
Other bias	Low risk	Clear antiplatelet protocol was the same in all arms.