Vroegindeweij 1995.

Study characteristics
Methods	Randomisation method: numbered envelopes opened sequentially Allocation: sealed envelopes, not stated if opaque Intervention model: parallel assignment Blinding: not stated, probably not done
Participants	Country: Netherlands No. of participants: 73 Simpson atherectomy: 38 BA: 35 Age (mean (years) range): Atherectomy: 64 (range 49 ‐ 77) BA: 64 (range 46 ‐ 80) Inclusion criteria: intermittent claudication of at least 3 months duration and obstructive lesions of the femoropopliteal arteries with a maximum length of 5 cm or complete occlusions shorter than 2 cm. Exclusion criteria: any previous ipsilateral femoropopliteal endovascular or operative intervention; participant unable to comply with the frequent follow‐up visits required by the protocol.
Interventions	BA versus Simpson atherectomy
Outcomes	Primary patency during follow‐up Restenosis as determined by duplex ultrasound
Notes	Four participants crossed over to the other treatment group: three participants had angioplasty following atherectomy, one participant had atherectomy in addition to angioplasty. Results were presented in an intention‐to‐treat format
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Numbered envelopes opened sequentially. Randomisation not performed until after inclusion and exclusion criteria evaluated.
Allocation concealment (selection bias)	Low risk	Sealed envelopes, not stated if opaque.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not stated, but impractical in trials of this type.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Not stated, probably not done.
Incomplete outcome data (attrition bias) All outcomes	High risk	Three participants in the BA group were not followed up to 6 months. One participant in the atherectomy group and 10 in the BA group were not followed up to one year.
Selective reporting (reporting bias)	Low risk	Primary patency reported fully in life‐table format; restenosis presented graphically.
Other bias	Low risk	Clear antiplatelet protocol.