Kouvelos 2013.

Methods	Design: prospective randomised, open‐label study Number of study centres: single centre in Greece Setting: inpatient and outpatient follow‐up Patient recruitment: patients who underwent elective vascular surgery from January 2007 to June 2009 Duration of study: 12 months Clinical setting: patients Undergoing elective vascular surgery
Participants	Enrolment (N): 262 Randomised (N): intervention: 126; control: 136 Withdrawn (N): intervention: 4; control: 2 Lost to follow‐up (N): Eight patients did not attend their follow‐up visit but were reached via telephone Completed the study (N): not reported Analysed (N): intervention: 126; control: 136 Age (years) (range): intervention: 70 (41‐89); control: 72 (46‐88) Sex (male, N, %): intervention: 113 (89.7%); control: 122 (89.7%) Smoking history (N, %): intervention: 68 (54%); control: 78 (57.4%) BMI (kg/m², mean ± SD):): not reported Diabetes (N, %): intervention: 40 (31.7%); control: 39 (28.7%) Hypertension (N, %): intervention: 103 (81.7%); control: 110 (80.9%) Existing CHD: (N, %): intervention: 62 (49.2%); control: 67 (49.3%) Statin pretreatment (N, %): intervention: 0%; control: 0% Inclusion criteria: Patients who underwent elective vascular surgery. Exclusion criteria: any contraindication to the use of statins; emergency surgery; a re‐operation within 30 days after a previous procedure; liver disease; a history of a cardiovascular event within the previous 6 months prior to randomisation (MI or stroke).
Interventions	Intervention: ezetimibe (10 mg/day) plus rosuvastatin (10 mg/day) Comparison: rosuvastatin alone (10 mg/day) Details of any 'run‐in' period: 8‐week washout period for the patients already on a statin Concomitant medications: not reported Excluded medications: not reported
Outcomes	Primary: composite of death from cardiac causes, nonfatal acute MI, ischaemic stroke, and unstable angina. Secondary: lipids and high‐sensitivity C‐reactive protein (hs‐CRP) Others: serum creatine kinase (CK) and AST levels as well as clinical evaluation of any adverse event.
Notes	Funding: Quote: "The author(s) received no financial support for the research, authorship, and/or publication of this article"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A computer algorithm was used in the randomisation
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Open‐label study, insufficient information to make a judgement
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Eight patients did not attend their follow‐up visit but were reached via telephone."
Selective reporting (reporting bias)	Unclear risk	No protocol published, or trials registry record found.
Other bias	Low risk	Funding:Quote: "The author(s) received no financial support for the research, authorship, and/or publication of this article" Declaration of Conflicting Interests: Quote: "no potential conflicts of interest with respect to the research, authorship, and/or publication of this article."