. 2010 Jan 20;2010(1):CD003228. doi:10.1002/14651858.CD003228.pub2
Copyright © 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Vroegindeweij 1997.
| Methods | Study design: single centre, randomised controlled trial with 2 parallel groups. Recruitment period two years. No power calculation | |
| Participants | Country: the Netherlands Sample size 51: 36 males, 15 females=15 Mean age (range): experimental group 65 (46‐78) years, control group 64 (41‐82) years Inclusion criteria: intermittent claudication; above knee femoropopliteal stenosis or occlusions, maximal length of lesion 5cm; no previous interventions in ipsilateral femoropoliteal segment. Exclusion criteria: multisegmental disease, poor run off, unable to comply with follow‐up protocol . | |
| Interventions | Experimental group: primary stenting using a balloon expanded Palmaz stent, n=24. Control: balloon angioplasty, n=27. | |
| Outcomes | Primary outcome: restenosis or reocclusion Secondary outcome Clinical: ABI, technical failure, embolic episodes, clinical deterioration and thrombosis. | |
| Notes | Only experimental group offered post‐interventional anticoagulant heparin pharmacotherapy. All patients started on oral coumadin after the procedure for the first three months, thereafter the treatment was changed to aspirin 80 mg/d indefinitely. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Unclear risk | Described as randomised; numbered envelopes opened sequentially. |
| Allocation concealment? | Unclear risk | Not clear if opaque envelopes. |
| Blinding? All outcomes | High risk | Neither the surgical or radiological staff were blinded and it remains unclear whether the subjects were themselves blinded. |
| Incomplete outcome data addressed? All outcomes | Low risk | "intention to treat".. "patients with crossover treatments remained assigned to the treatment group of randomization". |
| Free of selective reporting? | Low risk | All measures of technical and clinical success reported. |
| Free of other bias? | Low risk | No significant difference between groups of baseline risk factors or clinical status. |
ABPI = ankle brachial pressure index g = gram i.v. = intravenous