APVS study.
Methods | Atorvastatin in the Perioperative of Vascular Surgery (APVS) study. Single‐centre randomized controlled trial. | |
Participants | 106 participants undergoing vascular surgery (aortic aneurysm, carotid endarterectomy and lower limb arterial surgery) in University Hospital, Brazil. Statin naive. Mean age, 69.6 years in A20 group and 65.8 years in A80 group. |
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Interventions | High‐dose (80 mg/day) atorvastatin (A80) compared with 20 mg/day atorvastatin (A20). 53 participants in each group, received drug for 60 days. | |
Outcomes | Follow‐up for 30 days after surgery. Primary endpoint: composite of cardiac death, non‐fatal myocardial infarction and stroke. 3 events in A80 group and 7 events in A20 group. Secondary endpoint: reduction in total and low‐density cholesterol CRP. Safety monitored via hepatic enzymes and creatinine kinase. |
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Funding sources | No statement about funding sources. | |
Duration of statin use before surgery | 33 days average between randomization and surgery in both groups. | |
Notes | Study reported in two conference abstracts only. Emailed for further information 20/8/12 and 27/9/12. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were randomly assigned". No further details. |
Allocation concealment (selection bias) | Unclear risk | No details given. |
Blinding of participants and personnel (performance bias) Mortality /complications | Low risk | Study described as "double‐blind". |
Blinding of outcome assessment (detection bias) Mortality/complications | Unclear risk | Criteria and assessment process not described. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No details of losses to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | Premiminary reports only. Combined endpoint only reported. |
Other bias | Unclear risk | Insufficient information to assess other potential risks of bias. |