Shammas 2011.

Study characteristics
Methods	Randomisation method: simple randomisation was performed on a 1:1 basis, no method of sequence generation described Allocation: sealed envelopes, not stated if opaque Intervention model: parallel assignment Blinding: not stated
Participants	Country: United States of America No. of participants: participants: 58; vessels: 84 Silverhawk atherectomy plus BA: participants: 29; vessels: 36 BA: participants: 29; vessels: 48 Age (mean (years) ± SD): atherectomy: 67.4 ± 9.1 BA: 70.9 ± 13.9 Inclusion criteria: adults with claudication, rest pain or minor tissue loss Exclusion criteria: heavily calcified vessels; total occlusions longer than 10 cm or any total occlusion with suspicion of subintimal wire recanalisation; inability to take aspirin or adenosine diphosphate receptor antagonists; bleeding disorder or platelet count less than 100,000/L; creatinine level greater than 2.5 mg/dL; unwillingness to give consent or return for future follow‐up visits; ongoing active infection; decompensated congestive heart failure or acute coronary syndrome; or a staged vascular procedure during the same hospital stay or 1 week after the index procedure.
Interventions	BA versus Silverhawk atherectomy with adjunctive BA
Outcomes	Primary: TLR at 1 year Secondary The rate of “bailout” stent implantation because of suboptimal acute angiographic results, defined as a residual stenosis of more than 30% or the presence of type C–F dissection. Final acute angiographic results in each arm at the end of the procedure TLR at 1 year Major adverse events including major amputation, death, distal embolisation, vascular complications (arteriovenous fistula, pseudoaneurysm, or perforation), major bleeding (loss of 3 U of packed red blood cells with a source of bleeding, or intracranial or retroperitoneal bleeding), unplanned urgent revascularisation of the treated vessel in the same hospital stay, myocardial infarction, embolic stroke, and renal failure (i.e. increase in creatinine clearance by 25% versus preprocedure baseline). Change in the ABI at 1 month, 6 months, and 1 year after the procedure versus baseline
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Simple randomisation was performed on a 1:1 basis, no method of sequence generation described.
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	Primary outcome only reported for 51/84 (61%) vessels.
Selective reporting (reporting bias)	High risk	Secondary outcomes major adverse events and change in ABI incompletely reported.
Other bias	Low risk	Clear antiplatelet protocol.