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Atorvastatin Effect on Aortic Dilatation and Valvular Calcification Progression in Bicuspid Aortic Valve (BICATOR): A Randomized Clinical Trial.
- Source :
-
Circulation [Circulation] 2024 Jun 18; Vol. 149 (25), pp. 1938-1948. Date of Electronic Publication: 2024 May 28. - Publication Year :
- 2024
-
Abstract
- 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.<br />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.<br />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.<br />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.<br />Registration: URL: https://www.clinicaltrialsregister.eu; Unique identifier: 2015-001808-57. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02679261.<br />Competing Interests: Disclosures None.
- Subjects :
- Humans
Female
Male
Middle Aged
Adult
Dilatation, Pathologic drug therapy
Follow-Up Studies
Double-Blind Method
Treatment Outcome
Aorta diagnostic imaging
Aorta pathology
Aorta drug effects
Aortic Valve Disease drug therapy
Aortic Valve Stenosis
Atorvastatin therapeutic use
Aortic Valve diagnostic imaging
Aortic Valve pathology
Aortic Valve abnormalities
Aortic Valve drug effects
Disease Progression
Calcinosis drug therapy
Calcinosis diagnostic imaging
Calcinosis pathology
Bicuspid Aortic Valve Disease diagnostic imaging
Bicuspid Aortic Valve Disease drug therapy
Heart Valve Diseases drug therapy
Heart Valve Diseases diagnostic imaging
Heart Valve Diseases pathology
Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1524-4539
- Volume :
- 149
- Issue :
- 25
- Database :
- MEDLINE
- Journal :
- Circulation
- Publication Type :
- Academic Journal
- Accession number :
- 38804148
- Full Text :
- https://doi.org/10.1161/CIRCULATIONAHA.123.067537