Randomised controlled trial

Atorvastatin Effect on Aortic Dilatation and Valvular Calcification Progression in Bicuspid Aortic Valve (BICATOR): A Randomized Clinical Trial

CirculationPublished

  • Randomised controlled trial
  • placebo-controlled

28 patients (12.7%) discontinued treatment (15 on atorvastatin, 13 on placebo)

Authors' conclusion

Among patients with bicuspid aortic valve without severe valvular dysfunction, atorvastatin treatment was not effective in reducing the progression of ascending aorta dilation and aortic valve calcification during 3 years of treatment despite a significant reduction in low-density lipoprotein cholesterol levels.

Study context

Population
Adults with bicuspid aortic valve, nonsevere valvular dysfunction and calcification, ascending aorta diameter ≤50 mm192 completed 36 months
Participants
220 adults
Comparison
Atorvastatin vs placebo
Primary endpoint
Growth of maximum ascending aorta diameter
Follow-up
3 years

Primary result

As reported in the abstract

Increase in maximum ascending aorta diameter

P = 0.613

Further findings

Median, mg/dL

OutcomeAtorvastatinPlaceboP value
Change in LDL-C−30 (IQR −51.65 to −1.75 mg/dL)6 (IQR −4, 22.5 mg/dL)P < 0.001

Progression of aortic valve calcium score

No significant difference between groups
P = 0.167

Valvular dysfunction

No significant difference between groups

Original publication

Atorvastatin Effect on Aortic Dilatation and Valvular Calcification Progression in Bicuspid Aortic Valve (BICATOR): A Randomized Clinical Trial. Circulation. Published 28 May 2024. doi:10.1161/circulationaha.123.067537

Summarised from the published abstract; every number is checked against it