Ramo 1995.
Methods | Single‐centre randomized controlled trial. | |
Participants | 37 participants undergoing percutaneous transluminal angioplasty (PTA) below inguinal ligament for critical ischaemia or severe claudication (< 20 m). University Hospital, Helsinki, Finland. Not stated that statin naive. Mean age, 68 years 45% female. |
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Interventions | Intervention (N = 18): 20 mg/day lovastatin plus 250 mg aspirin/day. Commenced on referral and angiogram usually within 2 days. Assume continued for 1 year. Control (N = 19) had aspirin only. |
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Outcomes | Participants followed up for 1 year. Outcomes reported repeated PTA (4/18 statin and 8/19 control), time to repeat PTA, amputation (2/18 statin users and 4/19 control). |
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Funding sources | No statement about funding sources. | |
Duration of statin use before surgery | 2 days on average. | |
Notes | Authors emailed for further information 20/8/12 and 27/9/12. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "All patients were randomized into two groups". No further details given. |
Allocation concealment (selection bias) | Unclear risk | No details given. |
Blinding of participants and personnel (performance bias) Mortality /complications | High risk | No mention of blinding and no placebo given. |
Blinding of outcome assessment (detection bias) Mortality/complications | High risk | "Angiograms were evaluated by two experienced interventional radiologists independently and without knowing the treatment patients were receiving". But angiograms during 1‐year follow‐up initiated by clinical staff who were aware of allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed follow‐up. |
Selective reporting (reporting bias) | Low risk | Study objective was to study restenosis only. |
Other bias | Low risk | Statin group had worse clinical condition and fewer run‐off vessels at baseline. Therefore, reduced restenosis rate may be under‐estimate. |