Durazzo 2004.

Methods	Single‐centre randomized controlled trial.
Participants	100 participants scheduled for elective non‐cardiac vascular surgery－aortic,femoropopliteal and carotid procedures. University Hospital, Sao Paulo, Brazil. Statin naive. Atorvastatin: 66% > 65 years, 20% female. Placebo: 64% > 65 years, 22% female.
Interventions	50 participants randomly assigned to intervention group 20 mg/day atorvastatin. 44 participants underwent planned surgery. 50 participants randomly assigned to control group, placebo. 46 participants underwent planned surgery. 45‐Day course. Surgery not earlier than 2 weeks after start of therapy. Beta‐blockers if indicated by current guidelines. 56% in atorvastatin group, 64% in placebo group.
Outcomes	All‐cause mortality at 30 days: 7 in atorvastatin group, including 1 stroke; 10 in control group, including 1 cardiac death. Non‐fatal MI at 30 days: 3 in atorvastatin group and 8 in control group. Non‐fatal stroke at 30 days: 1 in control group. Adverse muscle effects: 1 participant with rhabdomyolysis and elevated aminotransferase levels in atorvastatin group. Study primary outcome: composite of death from cardiac causes, non‐fatal MI, ischaemic stroke and unstable angina. Hepatic transaminase and creatine kinase (CK) monitored during hospital stay. Lipid profile after discharge.
Funding sources	Supported by Fundacao de Amparo a Pesquisa do Estado de Sao Paulo, Brazil. Statement that no conflicts of interest present.
Duration of statin use before surgery	Average, 30 days before surgery.
Notes	Authors supplied additional data by email October 2012.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer algorithm used.
Allocation concealment (selection bias)	Low risk	Additional information from authors. "Adequate allocation concealment was obtained using sequentially numbered and sealed opaque envelopes and randomization was performed by the pharmacy of the hospital".
Blinding of participants and personnel (performance bias) Mortality /complications	Low risk	"All clinical and study investigators were blinded to study group assignments throughout all phases of the trial". Described as double‐blind. Authors confirmed that participants and clinical staff were blinded to study allocation.
Blinding of outcome assessment (detection bias) Mortality/complications	Low risk	Data collected by study investigators analysed by endpoint committee unaware of allocation.
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT: ll participants included in analysis, including 6 participants in atorvastatin group and 4 in placebo group who did not undergo surgery. These participants are not eligible and were excluded from analyses of cardiovascular outcomes. .
Selective reporting (reporting bias)	Low risk	All outcomes described in methods section reported.
Other bias	Low risk	Baseline characteristics, β‐blocker use and type of operation similar in the 2 groups.