Van der Linde 2011.

Methods	Randomised, double‐blind, placebo‐controlled trial.
Participants	Women and men between 18 and 45 years of age (mean of age 33 years). Total participants = 242; 63 randomised with congenital aortic valve stenosis and peak aortic valve velocity of 2.5 m/s. The median follow‐up was 2.4 years. Baseline Characteristics of Participants: Men: 70% (rosuvastatin group) and 73% (placebo group). Bicuspid Valve: 93% (rosuvastatin group) and 88% (placebo group). Tricuspid Valve: 7 % (rosuvastatin group) and 12% (placebo group). Mean Pressure Gradient, mean (± SD) mmHg = 27 (± 10) (rosuvastatin group) and 32 (± 17) (placebo group). Peak Pressure Gradient, mean (± SD) mmHg = 48 (± 18) (rosuvastatin group) and 56 (± 28) (placebo group). Aortic Valve Area, mean (± SD) cm² = 1.3 (± 0.4) (rosuvastatin group) and 1.3 (± 0.5) (placebo group). Peak AS Velocity, mean (± SD) m/s = 3.4 (± 0.7) (rosuvastatin group) and 3.6 (± 0.9) (placebo group). Most of the participants had a previous intervention (surgical valvulotomy or balloon valvuloplasty) and none or a grade 1 of aortic regurgitation. Systolic blood pressure, mean (± SD) mmHg = 129 (± 16) (rosuvastatin group) and 131 (±16) (placebo group). Diastolic blood pressure, mean (± SD) mmHg = 76 (± 10) (rosuvastatin group) and 78 (± 10) (placebo group). Aortic valve calcium = 40% (rosuvastatin group) and 36% (placebo group). Left ventricular hypertrophy = 20% (rosuvastatin group) and 33%(placebo group). LDL value, (± SD) = 106 mg/dL (± 31) (rosuvastatin group) and 104 mg/dL (± 35) (placebo group).
Interventions	Rosuvastatin 10 mg (n = 30) or matching placebo (n = 33).
Outcomes	Primary outcome: progression of peak aortic valve velocity. Secondary outcome: temporal changes in the left ventricular mass, ascending aortic diameter and N‐terminal pro‐brain natriuretic peptide.
Notes	Study Site: 6 tertiary referral centres for congenital heart disease in The Netherlands and Belgium.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Rosuvastatin and placebo groups were randomised using a computer program at the Erasmus Medical University Center pharmacology department, which had no access to the rest of data.
Allocation concealment (selection bias)	Low risk	A randomisation number was sent by pharmacology department to the site co‐ordinator and the study medication to the participants. The participants were unaware of the treatment assignment.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Patients, physicians and investigators were blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The investigators that evaluated all outcomes were blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Patients who withdrew from the study were well‐described all the randomised patients were evaluated.
Selective reporting (reporting bias)	Low risk	Study protocol is not available, but all data were properly reported.
Other bias	Low risk	There was no other bias. The study did not received support from any organisations.

LDL: low‐density lipoprotein
 SD: standard deviation