Randon 2010.

Methods	Country: Belgium Setting: Ghent University Hospital Study design: single‐centre RCT Level of randomisation: participant
Participants	No. of participants randomised: total of 38 limbs in 35 participants with critical limb ischaemia were randomised to angioplasty (n = 22) or primary stenting (n = 16) Exclusions post randomisation: 1 participant in the PTA group did not receive intervention (n = 1); reason: stenosis < 70% Shifted to another arm: none Number of participants evaluated: 22 in the PTA group and 16 in the stenting group Age (mean), years: 72 years old in both groups Gender: PTA group: 14 male/8 female; stenting group: 6 male/10 female Inclusion criteria: All patients with CLTI (Rutherford 4 to 6, Fontaine III and IV) hospitalised at the Department of Vascular Surgery, Ghent University Hospital, for primary angioplasty of 1 or more crural vessels were randomised to primary stenting or angioplasty alone. For most patients, this was a last attempt before major amputation because of intractable pain or tissue loss. Some had no adequate venous conduit or no surgical target vessel, and the level of comorbidity was generally too high for general anaesthesia (ASA scores III and IV). All patients with stenosis of 70% or occlusions of the crural arteries were considered suitable for endovascular therapy. The length of the lesion was not an exclusion criterion, as even stenoses or occlusions > 10 cm were accepted (an exclusion criterion in most angioplasty studies and registries) Exclusion criteria: acute limb ischaemia; multi‐segmental inflow lesions (longer than 3 cm) above the knee; sepsis; myocardial infarction during previous 14 days; blue toe syndrome (microembolisation); inability to ambulate. Patients who needed bypass surgery for popliteal or superficial femoral occlusions and those who needed simultaneous angioplasty of the crural and more then one proximal vessel were excluded Nine patients needed concomitant proximal angioplasty for stenosis: 6 patients at the level of the popliteal artery, 2 at the level of the superficial femoral artery, and 1 at the level of the common iliac artery. There were 20 men and 18 women. The mean age of all patients did not diverge statistically from the mean age of the subgroups (72 ± 9.8 years; range 50 to 88 years). In 15 limbs, 2 arteries were treated, and in 1 patient, all 3 crural arteries: only 1 of these vessels was included in the study
Interventions	Stenting group: The target lesion was pre‐dilated. Both coronary balloon expandable stents (Jostent, Jomed Benelux Multi‐link Vision Coronary Stent, Abbott, Abbott Park, IL, USA) and self‐expandable stents (Astron Pulsar Stent, Biotronik, Berlin, Germany; Xpert Stent, Abbott) were used PTA group (control): Bijou Dilatation Balloon (Boston Scientific, Natick, MA, USA), Fox SV Balloons (Abbott), or cutting balloons (Boston Scientific) were used Additional intervention: Additional devices were used in 4 participants: 1 participant in the PTA group had a residual stenosis of 50%, which was treated during the same procedure with a cutting balloon (Boston Scientific), and in 3 participants, an Excimer laser was used to cross the lesion Quote: "In five patients we performed a subintimal instead of a transluminal recanalisation (two in the stent group and three in the PTA group). When it was impossible to cross the lesion, even with the use of an Excimer laser (used in three patients), the procedure was considered a technical failure and patients were treated conservatively, by bypass surgery, or with a major amputation, according to the runoff state of the vessels and patient condition" Medication: Heparin was administrated at a dose of 5000 IU at the beginning of the intervention All participants were discharged on antiplatelet drugs: low‐molecular‐weight heparin at a therapeutic dose for 1 week, 75 mg clopidogrel per day for 2 months, and low‐dose aspirin (< 160 mg) indefinitely
Outcomes	Primary patency at 6 months and 12 months, defined as clinical primary patency: this means freedom from re‐stenosis; occlusion with recurrence of ischaemic rest pain or recurrence of ulceration, leading to redo angioplasty; bypass surgery; or major amputation Secondary patency at 6 months and 12 months, defined as freedom from redo angioplasty until recurrence of symptoms Limb salvage at 6 months and 12 months, defined as successful when a full‐length limb was preserved; an above‐the‐ankle amputation was considered a failure Patient survival at 6 months and 12 months Technical success, defined as the ability to cross the lesion and perform an angioplasty with > 30% re‐stenosis Quote: "Patients were examined every 3 – 6 months after discharge till the end of the trial. Standard duplex scanning was performed every 6 months by one independent experienced investigator to exclude bias. The PSV was measured over the stent if possible. In the case of angioplasty alone the PSV was measured over the whole length of the treated artery. When the PSV was > 400 cm/s or when the treated artery was re‐occluded, and the patients showed recurrence of rest pain, cessation of ulcer healing, or a new ulcer, a new angiography was performed. In most of the patients ABPI measurements were not possible or not reliable due to calcifications of the vessels. We preferred duplex over angiography for follow up because of the renal comorbidity of our patients and the fact that the most important outcome for these patients is not patency of the vessel but relief of rest pain and healing of their ulcers"
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was performed by computer‐generated randomization sequence"
Allocation concealment (selection bias)	Low risk	Quote: "The allocation sequence was concealed by means of sealed, consecutively numbered envelopes"
Blinding of participants and personnel (performance bias) All outcomes	High risk	None
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Standard duplex scanning was performed every 6 months by one independent experienced investigator to exclude bias"
Incomplete outcome data (attrition bias) All outcomes	Low risk	No losses to follow‐up
Selective reporting (reporting bias)	Low risk	None
Other bias	Unclear risk	Declaration of conflict of interest not stated in the paper