Bicuspid Aortic Valve Atorvastatin Treatment Study - BICATOR

Jun 17, 2024
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Author/Summarized by Author:
Amit Saha, MD
Summary Reviewer:
Dharam J. Kumbhani, MD, SM, FACC
Trial Sponsor:
Spanish Ministry of Science and Innovation; Spanish Society of Cardiology
Date Published:
06/17/2024
Date Updated:
06/17/2024
Original Posted Date:
06/17/2024
References

Contribution To Literature:

The BICATOR trial showed that in patients with bicuspid aortic valve, low to moderate dose atorvastatin was not associated with slower progression of ascending aortic dilation or valvular dysfunction compared with placebo.

Description:

The goal of the trial was to determine whether treatment with low to moderate dose atorvastatin is associated with progression of ascending aortic dilation, valvular dysfunction, or valve calcification in patients with bicuspid aortic valve (BAV).

Study Design

  • Randomized
  • Double-blind
  • Multicenter

Patients with BAV and nonsevere valve dysfunction were randomized to receive atorvastatin 20 mg daily (n = 110) or placebo (n = 110). Valve and ascending aortic characteristics were assessed at baseline and follow-up by transthoracic echocardiography (TTE) and computed tomography calcium scoring and angiography.

  • Total number of enrollees: 220
  • Duration of follow-up: 3 years
  • Median patient age: 46 years
  • Percentage female: 20%

Inclusion criteria:

  • Age ≥18 years
  • BAV on TTE or additional confirmatory imaging
  • Nonsevere valve calcification
  • Mean AV gradient <30 mm Hg
  • Aortic root and ascending aorta diameter ≤50 mm

Exclusion criteria:

  • Aortic regurgitation with vena contracta width ≥7 mm or regurgitant jet width ≥10 mm
  • Already receiving or with an indication for lipid-lowering therapy
  • Prior cardiac or aortic surgery
  • Prior aortic dissection or coarctation
  • Uncontrolled hypertension
  • Creatinine clearance <30 mL/min or serum creatinine >2.5 mg/dL

Other salient features/characteristics:

  • Median ascending aorta diameter: 41 mm
  • Percentage AV calcium score >0: 45%
  • Percentage mild or moderate aortic stenosis: 22%
  • Percentage mild or moderate aortic regurgitation: 49%

Principal Findings:

The primary outcome, mean increase from baseline ascending aorta diameter at 3 years, for atorvastatin vs. placebo, was: 0.65 vs. 0.74 mm (p = 0.613).

Secondary outcomes for atorvastatin vs. placebo at 3 years:

  • Mean increase in AV calcium score: 278.2 vs. 173.7 Agatston units (p = 0.167)
  • Mean increase in peak AV velocity: 1.7 vs. 1.9 m/s (p = 0.659)
  • Mean increase in regurgitant vena contracta width: 0.19 vs. 0.27 mm (p = 0.547)
  • Median change in low-density lipoprotein (LDL) cholesterol: -30.5 vs. +6 mg/dL (p < 0.001)

Interpretation:

Statins are known to slow the growth of abdominal aortic aneurysms, and limited observational data have suggested similar benefit in the ascending aorta. Similarly, several observational studies in patients with aortic stenosis have reported lower valve dysfunction progression in patients treated with statins compared with control subjects. However, none of these findings were supported in at least three randomized controlled trials (PROCAS, ASTRONOMER, and SEAS). The current study demonstrated no change in progression of ascending aortic dilatation or AV calcification or hemodynamics after 3 years of low to moderate dose atorvastatin therapy. Sustained decrease in total and LDL cholesterol confirmed good medication adherence in the treatment arm.

The annular rate of aortic enlargement was lower than expected in the control arm, which may have limited detection of any treatment effect over the study period. Moreover, atorvastatin was not associated with slower progression of AV calcification or the development of aortic stenosis or regurgitation. Exploratory subgroup analyses weakly suggested differences in aortic dilatation and valve calcification in patients <45 years old and with an AV calcium score of 0, respectively. Future studies in these populations may provide more information regarding the preventive efficacy of statin therapy in BAV.

References:

Evangelista A, Galian-Gay L, Guala A, et al. Atorvastatin Effect on Aortic Dilatation and Valvular Calcification Progression in Bicuspid Aortic Valve (BICATOR): A Randomized Clinical Trial. Circulation 2024;May 28:[Epub ahead of print].

Clinical Topics: Congenital Heart Disease and Pediatric Cardiology, Dyslipidemia, Valvular Heart Disease, Congenital Heart Disease, CHD and Pediatrics and Prevention, Lipid Metabolism, Statins

Keywords: Atorvastatin, Bicuspid Aortic Valve Disease


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