Rand 2006.

Methods	Country: Austria Setting: hospital Study design: RCT Level of randomisation: participant
Participants	No. of participants randomised: The study population consisted of 51 patients who were treated for critical chronic limb ischaemia (Fontaine stages III and IV), defined as rest pain, ischaemic ulcer, and gangrene. Patients with only claudication were not included in this study Exclusions post randomisation: none Number of participants evaluated: 51 participants with 95 lesions: PTA group: 27 participants (53 lesions), stent group: 24 participants (42 lesions) Shifted to another arm: none Number of participants evaluated: 51; 44 were consecutively investigated and randomised at 1 centre to treatment of lesions by either PTA or stent application; 7 from 2 other centres were enrolled Age (mean), years: 72; mean age for the individual group not specified Gender: did not specify Inclusion criteria: chronic critical limb ischaemia stages III and IV of the Fontaine classification; isolated stenosis > 70% or occlusion of the tibial arteries; up to 3 lesions; lesions that were up to 3 cm with cumulative lesion length ≤ 9 cm, including the tibiofibular trunk, anterior and posterior tibial arteries, and fibular artery. There was no further limitation regarding lesion position. Patients with a significant inflow obstruction at the pelvic or superficial femoral artery level were not included Exclusion criteria: evidence of a systemic coagulopathy with anticoagulant and antiplatelet treatment contraindicated; previously implanted stents in the target lesion; total occlusion in the target vessel following the target lesion; without distal runoff; inflammatory vascular disease; peptic ulcer or gastric/intestinal bleeding in the previous 6 months; clinically assessed intolerance to contrast medium
Interventions	PTA group: Lesions were routinely treated with a 5 Fr conventional balloon angioplasty catheter and guidewire (Bijou 2.5–4 mm, Boston Scientific, Galway, Ireland; guidewire M 0.035‐inch, Terumo, Tokyo, Japan) Stenting group: Stent applications were performed with a 0.014‐inch guidewire (HI Torque, Sparta Core 14, Guidant Corporation, Santa Clara, CA) and carbostents (Sorin, Biomedica, Italy) with diameter range of 2.0 to 4 mm and length of 15 to 25 mm Medication: At the beginning of the procedure, 5000 units of heparin was administered intra‐arterially Post‐interventional anticoagulation therapy for the PTA group consisted of low‐molecular‐weight heparin (Enoxaparin 2 to 40 mg) for 3 days and acetylsalicylic acid (ASA; ThromboAss, 100 mg per day permanently) Adjunct therapy for the stent group consisted of clopidogrel (Plavix), administered as a bolus of 300 mg on the day of the procedure and 75 mg per day orally for 4 weeks, and ASA medication permanently Quote: "Due to its main effect on early restenosis clopidogrel is given only to patients who have received stents and not to patients who underwent PTA, as early restenosis is not regarded a major problem in this patient group"
Outcomes	Primary endpoint: 6‐month angiographic patency rate of treated lesions, which was defined as re‐stenosis < 70% (threshold 1: critical re‐stenosis) or < 50% (threshold 2: subcritical re‐stenosis), documented by CTA or DSA Secondary endpoints: Minor and major amputations; major amputation referred to amputation above the metatarsal line Complications were classified according to recommended standards: major complications cause death, cause permanent disability, or necessitate revascularisation or other invasive treatment, or a prolonged hospital stay. Less significant complications were classified as minor complications Surgical revascularisation Death
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Random number generation not described
Allocation concealment (selection bias)	Low risk	Quote: "Numbered envelopes were prepared for one‐to‐one randomization to either PTA or primary stent placement. The randomization was performed per patient. Therefore, all lesions in a particular patient had to be treated by either PTA or primary stent placement" Type of envelope not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not reported
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Data evaluation performed by the 2 readers in a double‐blinded fashion
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Of the 51 patients, 2 patients died, 3 patients underwent amputation, 1 patient underwent major heart surgery, which did not allow further follow‐up, and 8 patients were lost to follow‐up" Survival analysis performed
Selective reporting (reporting bias)	Low risk	None
Other bias	Unclear risk	Quote: "Due to its main effect on early restenosis clopidogrel is given only to patients who have received stents and not to patients who underwent PTA, as early restenosis is not regarded a major problem in this patient group" Quote: "We also observed a higher incidence of PTAs than stent applications per patient. This might be due to a certain degree of investigator bias, as potentially one balloon can be used for several lesions in contrast to the necessity of one stent per lesion" Quote: "The study was supported by the Ludwig Boltzmann Institute for Radiologic Tumor Diagnosis and the Ludwig Boltzmann Institute of Interdisciplinary Vascular Research"