Dattilo 2014.

Study characteristics
Methods	Randomisation method: details of sequence generation not stated Allocation: sealed envelopes ‐ not stated if opaque Intervention model: parallel Blinding: not stated
Participants	Country: United States of America No. of participants: 50 OA + BA: 25 BA alone: 25 Age (mean (years) ± SD): OA + BA: 68.0 ± 11.0 BA alone: 71.3 ± 10.5 Inclusion criteria: eligible participants were 18 years or older; PAD with Rutherford class 2 to 4 symptoms and de novo FP lesions of ≥ 70% stenosis with fluoroscopically visible calcium; gave informed consent; all participants had to have at least 1 patent run‐off vessel Exclusion criteria: anticipated life span of less than 1 year; known allergy to heparin, aspirin, and clopidogrel, or sensitivity to contrast media; chronic renal failure; cardiac arrhythmias; congestive heart failure exacerbation; myocardial infarction
Interventions	OA + BA vs BA alone
Outcomes	Primary: freedom from TLR, including the need for adjunctive stenting or restenosis (PSVR ≥ 2.5 on duplex ultrasound) per lesion at 6 months. Secondary: changes in ABI and Rutherford Class from baseline to 30 days and 6 and 12 months
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No details given about method of random sequence generation.
Allocation concealment (selection bias)	Low risk	Randomisation performed only after guidewire passed and inclusion and exclusion criteria assessed. 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	No mention of blinding of outcome assessment.
Incomplete outcome data (attrition bias) All outcomes	High risk	Incomplete data set at 6 and 12 months, reasons for attrition not stated. Data only published for 45/50 (90%) at 6 months and 37/50 (74%) at 12 months.
Selective reporting (reporting bias)	Low risk	All primary and secondary outcomes reported.
Other bias	Unclear risk	Clear antiplatelet protocol specified, but unit of analysis issue as the trial randomised treated vessels