Vroegindeweij 1997.
Methods | Study design: RCT Method of randomisation: Concealed randomisation using sealed randomisation envelopes. Blinding: Unblinded, intention‐to‐treat. Exclusions post‐randomisation: None. Losses to follow‐up: None. Cross‐over to stenting in PTA group: 4. |
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Participants | Country: The Netherlands. Setting: Hospital. No. of participants: 51 (51 limbs). Age (mean): 64.5 years. Gender: 36 men, 15 women. Inclusion criteria: Lesions confined to femoropopliteal artery. Exclusion criteria: Below‐knee popliteal disease; multisegmental disease; disease > 5 cm in length. |
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Interventions | PTA (27): over the wire. Stent (24): stainless steel 'Palmaz'. 5000 iu heparin intraoperative. 3 months warfarin. |
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Outcomes | 6 weeks, 3, 6, 9, 12, 18 and 24 month follow‐up: ABI, treadmill test, duplex ultrasound. Primary patency defined as proximal peak velocity ratio > 2.5 on duplex ultrasound. |
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Notes | Runoff vessel patency at time of intervention unclear. Participants with coexisting ipsilateral proximal arterial stenosis included. Sponsor: No statement. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Concealed randomisation using sealed randomisation envelopes. |
Allocation concealment (selection bias) | Low risk | Concealed randomisation using sealed randomisation envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Impossible in this type of trial. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated but radiological investigations would show stent placement. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No statement on attrition. |
Selective reporting (reporting bias) | Low risk | All outcomes accounted for. |
Other bias | Unclear risk | Warfarin used initially then unclear medication protocol. |