阿托伐他汀对二叶式主动脉瓣（BICATOR）主动脉扩张和瓣膜钙化进展的影响：一项随机临床试验。
Atorvastatin Effect on Aortic Dilatation and Valvular Calcification Progression in Bicuspid Aortic Valve (BICATOR): A Randomized Clinical Trial.
机构信息
Servei 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.
CIBER-CV (A.E., A.G., G.T.-T., T.S., J.B., I.M., V.S., J.M.R.-C., E.F., D.S., A.R.-M., J.F.R.-P.), Instituto de Salud Carlos III, Madrid, Spain.
出版信息
Circulation. 2024 Jun 18;149(25):1938-1948. doi: 10.1161/CIRCULATIONAHA.123.067537. Epub 2024 May 28.
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]; <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 (=0.613). Similarly, no significant differences were found for the progression of the aortic valve calcium score (=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.
背景
升主动脉扩张和主动脉瓣退行性变是二叶式主动脉瓣患者的常见并发症。几项回顾性研究表明他汀类药物治疗可降低这些并发症的风险。本研究旨在确定阿托伐他汀治疗是否可有效减小二叶式主动脉瓣患者的主动脉直径生长，并减缓瓣钙化进展。
方法
在一项随机临床试验中，纳入了 220 名二叶式主动脉瓣患者（43 名女性；46±13 岁），每天给予 20mg 阿托伐他汀或安慰剂治疗 3 年。纳入标准为年龄≥18 岁、无严重瓣膜功能障碍、无严重瓣钙化、升主动脉直径≤50mm。基线时及治疗 3 年后进行计算机断层扫描和超声心动图检查。
结果
随访期间，28 名患者（12.7%）停止了药物治疗（阿托伐他汀组 15 名，安慰剂组 13 名）。因此，192 名患者完成了 36 个月的治疗。阿托伐他汀组的低密度脂蛋白胆固醇水平显著降低（中位数[四分位间距]，-30mg/dL[-51.65 至-1.75mg/dL]与 6mg/dL[-4，22.5mg/dL]；<0.001）。最大升主动脉直径在两组间均有增加，但无差异：阿托伐他汀组为 0.65mm（95%CI，0.45-0.85），安慰剂组为 0.74mm（95%CI，0.45-1.04）（=0.613）。同样，主动脉瓣钙评分的进展（=0.167）或瓣膜功能障碍也无显著差异。
结论
在无严重瓣膜功能障碍的二叶式主动脉瓣患者中，尽管低密度脂蛋白胆固醇水平显著降低，但阿托伐他汀治疗 3 年并不能有效减小升主动脉扩张和主动脉瓣钙化的进展。
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