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Atorvastatin Effect on Aortic Dilatation and Valvular Calcification Progression in Bicuspid Aortic Valve (BICATOR): A
Arturo Evangelista1,2,3, Laura Galian-Gay1,3, Andrea Guala2,3
1Servei de Cardiologia (A.E., L.G.-G., G.T.-T., A.R.-M., M.A.C., H.C.-C., I.F.-G., J.F.R.-P.), Hospital Universitari Vall d´Hebron, Barcelona, Spain.
Insights
Atorvastatin did not slow aortic dilation or valve calcification in patients with bicuspid aortic valve. This study found no significant differences between atorvastatin and placebo groups over three years.
Area of Science:
- Cardiology
- Medical Research
Background:
- Bicuspid aortic valve (BAV) is associated with ascending aorta dilation and aortic valve degeneration.
- Retrospective studies suggested statins may benefit BAV patients.
Purpose of the Study:
- To evaluate atorvastatin's efficacy in reducing aortic diameter growth in BAV patients.
- To determine if atorvastatin slows aortic valve calcification progression in BAV.
Main Methods:
- A randomized clinical trial involving 220 BAV patients treated with atorvastatin or placebo for 3 years.
- Inclusion criteria: age ≥18, non-severe valvular dysfunction/calcification, ascending aorta diameter ≤50 mm.
- Computed tomography and echocardiography assessed outcomes at baseline and 3 years.
Main Results:
- Low-density lipoprotein cholesterol significantly decreased in the atorvastatin group (P<0.001).
- No significant differences in ascending aorta diameter increase between atorvastatin (0.65 mm) and placebo (0.74 mm) groups (P=0.613).
- No significant differences in aortic valve calcification score progression or valvular dysfunction between groups (P=0.167).
Conclusions:
- Atorvastatin treatment did not effectively reduce ascending aorta dilation progression in BAV patients.
- Atorvastatin did not slow aortic valve calcification progression in BAV patients without severe valvular dysfunction.
- Despite lowering LDL, atorvastatin showed no benefit for these BAV complications over 3 years.
Background:
Ascending aorta dilation and aortic valve degeneration are common complications in patients with bicuspid aortic valve. Several retrospective studies have suggested the benefit of statins in reducing these complications. This study aimed to determine whether atorvastatin treatment is effective in reducing the growth of aortic diameters in bicuspid aortic valve and if it slows the progression of valve calcification.
Methods:
In a randomized clinical trial, 220 patients with bicuspid aortic valve (43 women; 46±13 years of age) were included and treated with either 20 mg of atorvastatin per day or placebo for 3 years. Inclusion criteria were ≥18 years of age, nonsevere valvular dysfunction, nonsevere valve calcification, and ascending aorta diameter ≤50 mm. Computed tomography and echocardiography studies were performed at baseline and after 3 years of treatment.
Results:
During follow-up, 28 patients (12.7%) discontinued medical treatment (15 on atorvastatin and 13 taking placebo). Thus, 192 patients completed the 36 months of treatment. Low-density lipoprotein cholesterol levels decreased significantly in the atorvastatin group (median [interquartile range], -30 mg/dL [-51.65 to -1.75 mg/dL] versus 6 mg/dL [-4, 22.5 mg/dL]; P<0.001). The maximum ascending aorta diameter increased with no differences between groups: 0.65 mm (95% CI, 0.45-0.85) in the atorvastatin group and 0.74 mm (95% CI, 0.45-1.04) in the placebo group (P=0.613). Similarly, no significant differences were found for the progression of the aortic valve calcium score (P=0.167) or valvular dysfunction.
Conclusions:
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.
Registration:
URL: https://www.clinicaltrialsregister.eu; Unique identifier: 2015-001808-57. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02679261.
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